Viracept
1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
ANNEX I 

 
SUMMARY OF PRODUCT CHARACTERISTICS 

 

 
 

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1. NAME OF THE MEDICINAL PRODUCT 
 
VIRACEPT 50 mg/g oral powder. 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
The bottle contains 144 g of oral powder. Each gram of oral powder contains nelfinavir mesilate 
corresponding to 50 mg of nelfinavir. 
 
Excipients: 
- Contains sucrose palmitate: 10.0 mg per gram of oral powder. 10.0 mg of sucrose palmitate, 

which is an ester, theoretically corresponds to maximally 5.9 mg of sucrose when fully 
hydrolysed. 

- Contains aspartame (E951): 20.0 mg of aspartame per gram of oral powder. 
- Contains potassium: 50.0 mg of dibasic potassium phosphate corresponding to 22.5 mg of 

potassium per gram of oral powder. 
See section 4.4 
 
For a full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Oral powder. 
White to off-white amorphous powder. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
VIRACEPT is indicated in antiretroviral combination treatment of human immunodeficiency virus 
(HIV-1) infected adults, adolescents and children of 3 years of age and older. 
 
In protease inhibitor (PI) experienced patients the choice of nelfinavir should be based on individual 
viral resistance testing and treatment history. 
 
See section 5.1. 
 
4.2 Posology and method of administration 
 
Therapy with VIRACEPT should be initiated by a physician experienced in the management of HIV 
infection. 
 
VIRACEPT is administered orally and should always be ingested with food (see section 5.2). 
 
Patients older than 13 years: VIRACEPT 250 mg tablets are recommended for adults and older 
children (see Summary of Product Characteristics for VIRACEPT 250 mg tablets). The recommended 
dose of VIRACEPT 50 mg/g oral powder is 1250 mg twice a day (BID) or 750 mg three times a day 
(TID), for patients unable to take tablets. All patients older than 13 years should take either 5 level 
scoops of the blue 5 gram spoon twice daily or 3 level scoops of the blue 5 gram spoon three times 
daily. The efficacy of the BID (twice daily) regimen has been evaluated versus the TID (three times 
daily) regimen primarily in patients naïve to PIs (see section 5.1)  
 

 

 
 

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Patients aged 3 to 13 years: for children, the recommended starting dose is 50-55 mg/kg BID or if 
using a TID regimen, 25 – 35 mg/kg body weight per dose. For children able to take tablets, 
VIRACEPT tablets may be administered instead of the oral powder (see Summary of Product 
Characteristics for VIRACEPT tablets). 
 
The recommended dose of VIRACEPT oral powder to be administered BID to children aged 3 to 13 
years, using a combination of both the white 1 gram and the blue 5 gram scoop is shown in the 
following table. The prescriber should advise the patient to use the handle of the second scoop to 
scrape off extra powder and obtain a level scoop. 
 

 
Dose to be administered two times a day to children aged 3 to 13 
 
Body weight 
of the patient in 
kg 
 

Blue Scoop           White Scoop 
   5 gram                          1 gram 
 

Total grams 
 of Powder 
  per dose 

  7.5 to  8.5  kg       1               plus         3       8 g 
  8.5 to 10.5 kg       2                               -      10 g 
10.5 to 12    kg       2               plus         2      12 g 
12    to 14    kg       2               plus         4      14 g 
14    to 16    kg       3               plus         1      16 g 
16    to 18    kg       3               plus         3      18 g 
18    to 22    kg       4               plus         1      21 g 
  over   22   kg       5                               -      25 g 

 
The recommended dose of VIRACEPT oral powder to be administered TID to children aged 3 to 13 
years, using a combination of both the white 1 gram and the blue 5 gram scoop is shown in the 
following table. The prescriber should advise the patient to use the handle of the second scoop to 
scrape off extra powder and obtain a level scoop. 
 

 
Dose to be administered three times a day to children aged 3 to 13 
 
Body weight 
of the patient in 
kg 
 

Blue Scoop           White Scoop 
   5 gram                          1 gram 
 

Total grams 
 of Powder 
  per dose 

  7.5 to  8.5  kg       1                                       5 g 
  8.5 to 10.5 kg       1              plus           1       6 g 
10.5 to 12    kg       1              plus           2       7 g 
12    to 14    kg       1              plus           3       8 g 
14    to 16    kg       2                    10 g 
16    to 18    kg       2              plus           1      11 g 
18    to 22  kg       2              plus           3      13 g 
  over   22    kg       3                                      15 g 

 
The oral powder may be mixed with a small amount of water, milk, formula, soy formula, soy milk, 
dietary supplements, or pudding.  Once mixed, the entire contents must be consumed in order to obtain 
the full dose. If the mixture is not consumed immediately, it must be stored under refrigeration, but 
storage must not exceed 6 hours. Acidic food or juice (e.g., orange juice, apple juice or apple sauce) 
are not recommended to be used in combination with VIRACEPT, because the combination may 
result in a bitter taste. VIRACEPT oral powder should not be reconstituted with water in its original 
container. 

 

 
 

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Renal and hepatic impairment: there are no data specific for HIV positive patients with renal 
impairment and therefore specific dosage recommendations cannot be made (see section 4.4). 
Nelfinavir is principally metabolised and eliminated by the liver. There are not sufficient data from 
patients with liver impairment and therefore specific dose recommendations cannot be made (see 
section 5.2). Caution should be used when administering VIRACEPT to patients with impaired renal 
or hepatic function. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients. 
 
Co-administration with medicinal products with narrow therapeutic windows and which are substrates 
of CYP3A4 [e.g., terfenadine, astemizole, cisapride, amiodarone, quinidine, pimozide, triazolam, 
orally administered midazolam (for caution on parenterally administered midazolam, see section 4.5), 
ergot derivatives, lovastatin and simvastatin, alfuzosin, and sildenafil when used for treatment of 
pulmonary arterial hypertension,  (for the use of sildenafil and other PDE-5 inhibitors in patients with 
erectile dysfunction, see section 4.5)]. 
 
Potent inducers of CYP3A (e.g., rifampicin, phenobarbital and carbamazepine) reduce nelfinavir 
plasma concentrations.  
Co- administration with rifampicin is contra-indicated due to a reduction in exposure to nelfinavir.  
Physicians should not use potent inducers of CYP 3A4 in combination with Viracept and should 
consider using alternatives when a patient is taking VIRACEPT (see section 4.5). 
 
Herbal preparations containing St. John’s wort (Hypericum perforatum) must not be used while taking 
nelfinavir due to the risk of decreased plasma concentrations and reduced clinical effects of nelfinavir 
(see section 4.5).  
 
VIRACEPT should not be co-administered with omeprazole due to a reduction in exposure to 
nelfinavir and its active metabolite M8 (Tert-butyl hydroxy nelfinavir). This may lead to a loss of 
virologic response and possible resistance to VIRACEPT (see section 4.5). 
 
4.4 Special warnings and precautions for use 
 
Patients should be instructed that VIRACEPT is not a cure for HIV infection, that they may continue 
to develop infections or other illnesses associated with HIV disease, and that VIRACEPT has not been 
shown to reduce the risk of transmission of HIV disease through sexual contact or blood 
contamination. 
 
Immune reactivation syndrome: In HIV-infected patients with severe immune deficiency at the time of 
institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic 
or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of 
symptoms. Typically, such reactions have been observed within the first few weeks or months of 
initiation of CART. Relevant examples are cytomegalovirus retinitis, generalised and/or focal 
mycobacterium infections, and Pneumocystis carinii pneumonia. Any inflammatory symptoms should 
be evaluated and treatment instituted when necessary. 
 
Liver disease: The safety and efficacy of nelfinavir has not been established in patients with 
significant underlying liver disorders. Patients with chronic hepatitis B or C and treated with 
combination antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic 
adverse events. In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the 
relevant product information for these medicinal products. 
Patients with pre-existing liver dysfunction including chronic active hepatitis have an increased 
frequency of liver function abnormalities during combination antiretroviral therapy and should be 
monitored according to standard practice. If there is evidence of worsening liver disease in such 
patients, interruption or discontinuation of treatment must be considered. The use of nelfinavir in 

 

 
 

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patients with moderate hepatic impairment has not been studied. In the absence of such studies, 
caution should be exercised, as increases in nelfinavir levels and/or increases in liver enzymes may 
occur.  
Patients with hepatic impairment should not be given colchicine with VIRACEPT. 
 
Osteonecrosis: Although the aetiology is considered to be multifactorial (including corticosteroid use, 
alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis 
have been reported particularly in patients with advanced HIV-disease and/or long-term exposure to 
combination antiretroviral therapy (CART). Patients should be advised to seek medical advice if they 
experience joint aches and pain, joint stiffness or difficulty in movement. 
 
Renal impairment: Since nelfinavir is highly bound to plasma proteins, it is unlikely that it will be 
significantly removed by haemodiaylisis or peritoneal dialysis. Therefore, no special precautions or 
dose adjustments are required in these patients.  
Patients with renal impairment should not be given colchicine with VIRACEPT. 
 
Diabetes mellitus and hyperglycaemia: New onset diabetes mellitus, hyperglycaemia or exacerbation 
of existing diabetes mellitus has been reported in patients receiving PIs. In some of these the 
hyperglycaemia was severe and in some cases also associated with ketoacidosis. Many patients had 
confounding medical conditions, some of which required therapy with agents that have been 
associated with the development of diabetes or hyperglycaemia. 
 
Patients with haemophilia: There have been reports of increased bleeding, including spontaneous skin 
haematomas and haemarthroses, in haemophiliac patients type A and B treated with PIs. In some 
patients additional factor VIII was given. In more than half of the reported cases, treatment with PIs 
was continued or reintroduced if treatment had been discontinued. A causal relationship has been 
evoked, although the mechanism of action has not been elucidated. Haemophiliac patients should 
therefore be made aware of the possibility of increased bleeding. 
 
Lipodystrophy: Combination antiretroviral therapy has been associated with the redistribution of body 
fat (acquired lipodystrophy) in HIV patients. The long-term consequences of these events are currently 
unknown. Knowledge about the mechanism is incomplete. A connection between visceral lipomatosis 
and PIs and lipoatrophy and nucleoside analogue reverse transcriptase inhibitors (NRTIs) has been 
hypothesised. A higher risk of lipodystrophy has been associated with individual factors such as older 
age, and with drug related factors such as longer duration of antiretroviral treatment and associated 
metabolic disturbances. Clinical examination should include evaluation for physical signs of fat 
redistribution. Consideration should be given to the measurement of fasting serum lipids and blood 
glucose. Lipid disorders should be managed as clinically appropriate (see section 4.8).  
 
PDE5 inhibitors: particular caution should be used when prescribing sildenafil, tadalafil or vardenafil 
for the treatment of erectile dysfunction in patients receiving VIRACEPT. Co-administration of 
VIRACEPT with these medicinal products is expected to increase their concentrations and may result 
in associated adverse events such as hypotension, syncope, visual changes and prolonged erection (see 
section 4.5). Concomitant use of sildenafil prescribed for the treatment of pulmonary arterial 
hypertension with VIRACEPT is contraindicated (see section 4.3). 
 
HMG-CoA reductase inhibitors (statins): HMG-CoA reductase inhibitors may interact with 
protease inhibitors and increase the risk of myopathy, including rhabdomyolysis. Concomitant use of 
protease inhibitors with lovastatin or simvastatin is contraindicated. Other HMG-CoA reductase 
inhibitors may also interact with protease inhibitors and should be used with caution.  
 
Excipients: VIRACEPT oral powder contains aspartame (E951) as a sweetening agent. Aspartame 
provides a source of phenylalanine and, therefore, may not be suitable for persons with 
phenylketonuria. 
VIRACEPT oral powder contains potassium.  

 

 
 

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VIRACEPT oral powder also contains sucrose. Patients with rare hereditary problems of fructose 
intolerance, glucose-galactose malabsorption or sucrase-isomaltese insufficiency should not take this 
medicine. 
See section 2 and 6.1 for further information on excipients. 
 
Concurrent administration of salmeterol with VIRACEPT is not recommended. The combination may 
result in increased risk of cardiovascular adverse events associated with salmeterol, including QT 
prolongation, palpitations and sinus tachycardia. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Nelfinavir is primarily metabolised via the cytochrome P450 isoenzymes CYP3A4 and CYP2C19 (see 
section 5.2). Nelfinavir is also an inhibitor of CYP 3A4. Based on in vitro data, nelfinavir is unlikely 
to inhibit other cytochrome P450 isoforms at concentrations in the therapeutic range. 
 
Combination with other medicinal products: Caution is advised whenever VIRACEPT is co-
administered with agents that are inducers or inhibitors and/or substrates of CYP3A4; such 
combinations may require dose adjustment (see also sections 4.3 and 4.8). 
 
Substrates for CYP3A4: Co-administration is contraindicated with the following agents that are 
substrates for CYP3A4 and that have narrow therapeutic windows:  
terfenadine, astemizole, cisapride, amiodarone, quinidine, ergot derivatives, pimozide, oral 
midazolam, triazolam, alfuzosin, and sildenafil when used to treat pulmonary arterial hypertension 
(see section 4.3). 
 
Co-administration of a PI with sildenafil is expected to substantially increase sildenafil concentration 
and may result in an increase in sildenafil associated adverse events, including hypotension, visual 
changes, and priapism. 
 
For other substrates of CYP3A4 a dose reduction or consideration of an alternative may be required 
(Table 1).  
Coadministration of nelfinavir with fluticasone proprionate may increase plasma concentrations of 
fluticasone propionate. Consider alternatives that are not metabolised by CYP3A4 such as 
beclomethasone. 
Concomitant use of trazodone and nelfinavir may increase plasma concentrations of trazodone and a 
lower dose of trazodone should be considered. 
 
Coadministration of nelfinavir with simvastatin or lovastatin may result in significant increases in 
simvastatin and lovastatin plasma concentrations and is contraindicated (see section 4.3). Consider 
alternatives that are not substrates of CYP3A4 such as pravastatin or fluvastatin.Other HMG-CoA 
reductase inhibitors may also interact with protease inhibitors and should be used with caution.  
Concurrent administration of salmeterol with VIRACEPT is not recommended. The combination may 
result in increased risk of cardiovascular adverse events associated with salmeterol, including QT 
prolongation, palpitations and sinus tachycardia.  
Coadministration of warfarin and VIRACEPT may affect concentrations of warfarin. It is 
recommended that the international normalized ratio (INR) be monitored carefully during treatment 
with VIRACEPT, especially when commencing therapy. 
 
Metabolic enzyme inducers: Potent inducers of CYP3A4 (e.g., rifampicin, pehnobarbital and 
carbamazepine) may reduce nelfianvir plasma concentrations and their coadministration is 
contraindicated (see section 4.3). Caution should be used when co-administering other agents that 
induce CYP3A4   Plasma concentrations of midazolam are expected to be significantly higher when 
midazolam is given orally and should therefore not be coadministered with nelfinavir.  Parenteral 
midazolam should be coadministered with nelfinavir in an intensive care unit to ensure close clinical 
monitoring. Dose adjustment for midazolam should be considered if more than a single dose is 
administered (Table 1)   
 

 

 
 

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Metabolic enzyme inhibitors:Co-administration of nelfinavir with inhibitors of CYP2C19 (e.g., 
fluconazole, fluoxetine, paroxetine, lansoprazole, imipramine, amitriptyline and diazepam) may be 
expected to reduce the conversion of nelfinavir to its major active metabolite M8 (tert-butyl hydroxy 
nelfinavir) with a concomitant increase in plasma nelfinavir levels (see section 5.2). Limited clinical 
trial data from patients receiving one or more of these medicinal products with nelfinavir indicated 
that a clinically significant effect on safety and efficacy is not expected. However, such an effect 
cannot be ruled out. 
 
Interactions of nelfinavir with selected compounds that describe the impact of nelfinavir on the 
pharmacokinetics of the co-administered compound and the impact of other drugs on 
pharmacokinetics of nelfinavir are listed in Table 1. 
 
Table 1: Interactions and dose recommendations with other medical products 
Medicinal product by 
therapeutic areas 
(dose of nelfinavir 
used in study) 

 
Effects on drug levels 
% Change 

 
Recommendations concerning 
coadministration 

NRTIs 
  Clinically significant interactions 

have not been observed between 
nelfinavir and nucleoside 
analogues. At present, there is no 
evidence of inadequate efficacy 
of zidovudine in the CNS that 
could be associated with the 
modest reduction in plasma levels 
of zidovudine when co-
administered with nelfinavir. 
Since it is recommended that 
didanosine be administered on an 
empty stomach, VIRACEPT 
should be administered (with 
food) one hour after or more than 
2 hours before didanosine. 

Protease Inhibitors 
Ritonavir 500 mg single dose 
(nelfinavir 750 mg tid 6 days) 

Ritonavir AUC ↔ 
Ritonavir Cmax ↔ 
Nelfinavir concentrations not 
measured 

No dosage adjustment for needed 
for either product 

Ritonavir 500 mg BID, 3 doses 
(nelfinavir 750 single dose) 

Ritonavir concentrations not 
measured 
Nelfinavir AUC ↑ 152 %  
  

No dosage adjustment for needed 
for either product 

Ritonavir 100 mg or 200 mg BID 
(nelfinavir 1250 mg BID morning 
administration) 

Ritonavir concentrations not 
measured 
Nelfinavir AUC ↑ 20% 
M8 metabolite AUC ↑ 74% 

Ritonavir 100 mg or 200 mg BID 
(nelfinavir 1250 mg BID evening 
administration) 

Ritonavir concentrations not 
measured 
Nelfinavir AUC ↑ 39 % 
M8 metabolite AUC ↑ 86% 

There were no significant 
differences between low doses of 
ritonavir (either 100 or 
200 mg BID) for effects on AUCs 
of nelfinavir and M8. The clinical 
relevance of these findings has 
not been established. 

Indinavir 800 mg single dose 
(nelfinavir 750 mg TID X 7 days) 

Indinavir AUC ↑ 51% 
Indinavir Cmax ↔ 
Nelfinavir concentrations not 
measured 

Indinavir 800 mg Q8H X 7 days 
(nelfinavir 750 mg single dose) 

Indinavir concentrations not 
measured 
Nelfinavir AUC ↑ 83% 

The safety of the combination 
indinavir + nelfinavir has not 
been established 

Saquinavir 1200 mg single dose 
(nelfinavir 750 mg TID X 4 days) 

Saquinavir AUC ↑ 392%  
Nelfinavir concentrations not 
measured 

 

 

 
 

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Medicinal product by 
therapeutic areas 
(dose of nelfinavir 
used in study) 

 
Effects on drug levels 
% Change 

 
Recommendations concerning 
coadministration 

Saquinavir 1200 mg TID 
(nelfinavir 750 mg single dose) 

Saquinavir concentrations not 
measured 
Nelfinavir AUC ↑ 30% 
 

 

Amprenavir 800 mg TID 
(nelfinavir 750 mg TID) 

Amprenavir AUC ↔ 
Amprenavir Cmin ↑ 189 %  
Nelfinavir AUC ↔ 
 

No dosage adjustment for needed 
for either product 

Non-nucleoside Analogue Reverse Transcriptase Inhibitors (NNRTIs) 
Efavirenz 600 mg QD 
(Nelfinavir 750 mg TID) 

Efavirenz AUC ↔ 
Nelfinavir AUC ↓ 20 %  
 

No dosage adjustment for needed 
for either product 

Delavirdine 400 mg TID 
(Nelfinavir 750 mg TID) 

Delavirdine AUC ↓ 31 % 
Nelfinavir AUC ↑ 107 % 
 

Safety of combination not 
established; combination not 
recommended 

Nevirapine  
 

 Dose adjustment is not needed 
when nevirapine is administered 
with nelfinavir. 

Anti infective Agents 
Rifabutin 300 mg QD 
(Nelfinavir 750 mg TID) 

Rifabutin AUC ↑ 207 % 
Nelfinavir AUC ↓ 32 % 

Dosage reduction of rifabutin to 
150 mg QD is necessary when 
nelfinavir 750 mg TID or 
1250 mg BID and rifabutin are 
co-administered. 

Rifabutin 150 mg QD 
(Nelfinavir 750 mg TID) 

Rifabutin AUC ↑ 83 % 
Nelfinavir AUC ↓ 23 % 

Dosage reduction of rifabutin to 
150 mg QD is necessary when 
nelfinavir 750 mg TID or 
1250 mg BID and rifabutin are 
co-administered 

Rifampicin 600 mg qd x 7 days 
(Nelfinavir 750 mg q8h x 5-6 
days) 

Rifampicin concentrations not 
measured 
Nelfinavir AUC ↓82%  

Concomitant use of rifampicin is 
contraindicated with nelfinavir 

Ketoconazole  Ketoconazole concentrations not 
measured 
Nelfinavir AUC ↑35% 

Coadministration of nelfinavir 
and a strong inhibitor of CYP3A, 
ketoconazole, resulted in a 35 % 
increase in nelfinavir plasma 
AUC.The changes in nelfinavir 
concentrations are not considered 
clinically significant and no dose 
adjustment is needed when 
ketoconazole and nelfinavir are 
co-administered.  

Oral Contraceptives  
17 α-Ethinyl estradiol 35 μg qd x 
15 days 
(Nelfinavir 750 mg q8h x 7 days) 

Ethinyl estradiol AUC ↓47%  
Nelfinavir concentrations not 
measured 

Contraceptives with ethinyl 
estradiol should not be 
coadministered with nelfinavir. 
Alternative contraceptive 
measures should be considered. 

Norethindrone 0.4 mg qd x 15 
days 
(Nelfinavir 750 mg q8h x 7 days) 

Norethindrone AUC ↓18% 
Nelfinavir concentrations not 
measured 
 

Contraceptives with 
norethindrone should not be 
coadministered with nelfinavir. 
Alternative contraceptive 
measures should be considered. 

 

 
 

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Medicinal product by 
therapeutic areas 
(dose of nelfinavir 
used in study) 

 
Effects on drug levels 
% Change 

 
Recommendations concerning 
coadministration 

HMG-CoA reductase inhibitors (Statins) 
  Since increased concentrations of 

HMG-CoA reductase inhibitors 
may cause myopathy, including 
rhabdomyolysis, the combination 
of these medicinal products with 
nelfinavir is not recommended. 

Simvastatin or 
lovastatin(Nelfinavir 1250 mg 
bid) 

Simvastatin AUC ↑ 505% 
Nelfinavir AUC ↔ 
concentrations not measured 

Combination of simvastatin or 
lovastatin and nelfinavir is 
contraindicated (see 
contraindication) 

Atorvastatin 10 mg qd 
(Nelfinavir 1250 mg bid) 

Atorvastatin AUC ↑ 74 % 
Nelfinavir AUC concentrations 
not measured 

Atorvastatin is less dependent on 
CYP3A4 for metabolism. When 
used with nelfinavir, the lowest 
possible dose of atorvastatin 
should be administered.  

Pravastatin, fluvastatin, 
rosuvastatin 

 The metabolism of pravastatin, 
and fluvastatin is not dependent  
on CYP3A4, and interactions are 
not expected withnelfinavir. If 
treatment with HMG-CoA 
reductase inhibitors is indicated 
in combination with nelfinavir, 
pravastatin or fluvastatin are 
recommended. Rosuvastatin may 
also be administered with 
nelfinavir but patients should be 
monitored. 
 

Anticonvulsants 
Phenytoin 300 mg qd x 7 days 
(Nelfinavir 1250 mg bid x 14 
days) 

Phenytoin AUC ↓29%  
Free Phenytoin ↓28% 

No dose adjustment for nelfinavir 
is recommended. Nelfinavir may 
lead to decreased AUC of 
phenytoin; therefore phenytoin 
concentrations should be 
monitored during concomitant 
use with nelfinavir.  

Proton Pump Inhibitors 
Omeprazole 20 mg bid x 4 days 
administered 30 minutes before 
nelfinavir 
(Nelfinavir 1250 mg bid x 4 days) 

Omeprazole concentrations not 
measured 
Nelfinavir AUC ↓36%  
Nelfinavir Cmax ↓37%  
Nelfinavir Cmin ↓39%  
M8 metabolite AUC ↓92% 
M8 metabolite Cmax ↓ 89% 
M8 metabolite Cmin ↓ 75% 

Omeprazole should not be co-
administered with nelfinavir. The 
absorption of nelfinavir may be 
reduced in situations where the 
gastric pH is increased 
irrespective of cause. Co-
administration of nelfinavir with 
omeprazole may lead to a loss of 
virologic response and therefore 
concomitant use is contra-
indicated. Caution is 
recommended when nelfinavir is 
co-administered with other proton 
pump inhibitors 

 

 
 

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Medicinal product by 
therapeutic areas 
(dose of nelfinavir 
used in study) 

 
Effects on drug levels 
% Change 

 
Recommendations concerning 
coadministration 

Sedatives/Anxiolytics 
Midazolam No drug interaction study has 

been performed for the co-
administration of nelfinavir with 
benzodiazepines. 

Midazolam is extensively 
metabolised by CYP3A4. Co-
administration of midazolam with 
nelfinavir may cause a large 
increase in the concentration of 
this benzodiazepine. Based on 
data for other CYP3A4 inhibitors, 
plasma concentrations of 
midazolam are expected to be 
significantly higher when 
midazolam is given orally. 
Therefore nelfinavir should not 
be co-administered with orally 
administered midazolam. If 
nelfinavir is co-administered with 
parenteral midazolam, it should 
be done in an intensive care unit 
(ICU) or similar setting which 
ensures close clinical monitoring 
and appropriate medical 
management in case of 
respiratory depression and/or 
prolonged sedation. Dosage 
adjustment for midazolam should 
be considered, especially if more 
than a single dose of midazolam 
is administered 

H1 Receptor Antagonists, 5-HT Agonists 
Terfenadine, astemizole, 
cisapride 

Nelfinavir increases terfenadine 
plasma concentrations. Similar 
interactions are likely with 
astemizole and cisapride. 

Nelfinavir must not be 
administered concurrently with 
terfenadine, astemizole or 
cisapride because of the potential 
for serious and/or life-threatening 
cardiac arrhythmias. 

Endothelin receptor antagonists 
Bosentan Not studied. Concomitant use of 

bosentan and nelfinavir may 
increase plasma levels of 
bosentan. 

When administered 
concomitantly with nelfinavir, the 
patient’s tolerability of bosentan 
should be monitored. 

Analgesics 
Methadone 80 mg + 21 mg qd > 
1 month 
(Nelfinavir 1250mg bid x 8 days 

Methadone AUC ↓47%  
 

None of the subjects experienced 
withdrawal symptoms in this 
study; however, due to the 
pharmacokinetic changes, it 
should be expected that some 
patients who received this 
combination may experience 
withdrawal symptoms and require 
an upward adjustment of the 
methadone dose.  
Methadone AUC may be 
decreased when co-administered 
with nelfinavir; therefore upward 
adjustment of methadone dose 
may be required during 
concomitant use with nelfinavir. 

 

 
 

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Medicinal product by 
therapeutic areas 
(dose of nelfinavir 
used in study) 

 
Effects on drug levels 
% Change 

 
Recommendations concerning 
coadministration 

Inhaled/nasal steroid 
Fluticasone ↑ Fluticasone Concomitant use of fluticasone 

propionate and VIRACEPT may 
increase plasma concentrations of 
fluticasone propionate. Use with 
caution. Consider alternatives to 
fluticasone propionate, that are 
not metabolised by CYP3A4, 
such as beclometasone, 
particularly for long-term use. 

Antidepressants 
Trazodone ↑ Trazodone  Concomitant use of trazodone 

and VIRACEPT may increase 
plasma concentrations of 
trazodone. The combination 
should be used with caution and a 
lower dose of trazodone should 
be considered.  

PDE-5 inhibitors for the treatment of pulmonary arterial hypertension (PAH) 
Tadalafil Not studied. Concomitant use of 

tadalafil and nelfinavir may 
increase plasma levels of 
tadalafil. 

Co-administration of tadalafil for 
the treatment of pulmonary 
arterial hypertension with 
VIRACEPT is not recommended. 

Sildenafil Not studied. Concomitant use of 
sildenafil and nelfinavir may 
increase plasma levels of 
sildenafil. 

Sildenafil is contraindicated when 
coadministered with VIRACEPT 
(see contraindications). 

PDE-5 inhibitors for the treatment of erectile dysfunction (ED) 
Tadalafil Not studied. Concomitant use of 

tadalafil and nelfinavir may 
increase plasma levels of 
tadalafil. 

Use with increased monitoring 
for adverse events associated with 
increased exposure to tadalafil. 

Sildenafil Not studied. Concomitant use of 
sildenafil and nelfinavir may 
increase plasma levels of 
sildenafil. 

Sildenafil at a starting dose not 
exceeding 25 mg in 48 hours.  
Use with increased monitoring 
for adverse events associated with 
increased exposure to sildenafil. 

Vardenafil Not studied. Concomitant use of 
vardenafil and nelfinavir may 
increase plasma levels of 
vardenafil. 

Use with increased monitoring 
for adverse events associated with 
increased exposure to vardenafil. 

Antigout preparation 
Colchicine Not studied. Concomitant use of 

colchicine and nelfinavir may 
increase plasma levels of 
colchicine. 

A reduction in colchicine dosage 
or an interruption of colchicine 
treatment is recommended in 
patients with normal renal or 
hepatic function if treatment with 
nelfinavir is required. Patients 
with renal or hepatic impairment 
should not be given colchicine 
with nelfinavir (see section 4.4). 

 

 
 

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Medicinal product by 
therapeutic areas 
(dose of nelfinavir 
used in study) 

 
Effects on drug levels 
% Change 

 
Recommendations concerning 
coadministration 

Herbal Products 
St. John’s wort Plasma levels of nelfinavir can be 

reduced by concomitant use of 
the herbal preparation St. John’s 
wort (Hypericum perforatum). 
This is due to induction of drug 
metabolising enzymes and/or 
transport proteins by St. John’s 
wort. 

Herbal preparations containing 
St. John’s wort must not be used 
concomitantly with nelfinavir. If 
a patient is already taking 
St. John’s wort, stop St. John’s 
wort, check viral levels and if 
possible nelfinavir levels. 
Nelfinavir levels may increase on 
stopping St. John’s wort, and the 
dose of nelfinavir may need 
adjusting. The inducing effect of 
St. John’s wort may persist for at 
least 2 weeks after cessation of 
treatment. 

↑ Indicates increase, ↓ indicates decrease, ↔ indicates minimal change (< 10 %) 
 
4.6 Fertility, pregnancy and lactation 
 
No treatment-related adverse reactions were seen in animal reproductive toxicity studies in rats at 
doses providing systemic exposure comparable to that observed with the clinical dose. Clinical 
experience in pregnant women is limited. VIRACEPT should be given during pregnancy only if the 
expected benefit justifies the possible risk to the foetus.  
 
It is recommended that HIV-infected women must not breast-feed their infants under any 
circumstances in order to avoid transmission of HIV. Studies in lactating rats showed that nelfinavir is 
excreted in breast milk. There is no data available on nelfinavir excretion into human breast milk. 
Mothers must be instructed to discontinue breast-feeding if they are receiving VIRACEPT.  
 
4.7 Effects on ability to drive and use machines 
 
VIRACEPT has no or negligible influence on the ability to drive and use machines. 
 
4.8 Undesirable effects 
 
The safety of the VIRACEPT 250 mg tablet was studied in controlled clinical trials with over 
1300 patients. The majority of patients in these studies received either 750 mg TID either alone or in 
combination with nucleoside analogues or 1250 mg BID in combination with nucleoside analogues. 
The following adverse events with an at least possible relationship to nelfinavir (i.e. adverse reactions) 
were reported most frequently: diarrhoea, nausea, and rash. Within each frequency grouping, 
undesirable effects are presented in order of decreasing seriousness. 
 
Adverse reactions from clinical trials with nelfinavir 
 
Adverse reactions in clinical studies are summarised in Table 2. The list also includes marked 
laboratory abnormalities that have been observed with nelfinavir (at 48 weeks). 
 

 

 
 

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Table 2: Incidences of Adverse Reactions and marked laboratory abnormalities from the phase 
II and phase III studies. (Very common (≥ 10 %); common (≥ 1 % and < 10 %) 

Body System 
Frequency of Reaction 

Adverse Reactions 

 Grades 3&4 All Grades 
Gastrointestinal disorders 
Very common  Diarrhoea 
Common  Nausea, flatulence,  
Skin and subcutaneous tissue disorders 
Common  Rash 
Investigations 
Common  Increased alanine aminotransferase, 

increased aspartate aminotransferase, 
neutropenia, blood creatinine 
phosphokinase increased, neutrophil 
count decreased 
 

 
Children and neonates: 
A total of approximately 400 patients received nelfinavir in paediatric treatment trials (Studies 524, 
556, PACTG 377/725, and PENTA-7) for up to 96 weeks. The adverse reaction profile seen during 
paediatric clinical trials was similar to that for adults. Diarrhoea was the most commonly reported 
adverse event in children. Neutropenia/leukopenia was the most frequently observed laboratory 
abnormality. During these trials less than 13% of patients in total discontinued treatment due to 
adverse events. 
 
Post-marketing experience with nelfinavir 
Serious and non-serious adverse reactions from post-marketing spontaneous reports (where nelfinavir 
was taken as the sole protease inhibitor or in combination with other antiretroviral therapy), not 
mentioned previously in section 4.8, for which a causal relationship to nelfinavir cannot be excluded, 
are summarised below. As these data come from the spontaneous reporting system, the frequency of 
the adverse reactions is not confirmed. 
 
Immune system disorders: 
Uncommon (≥ 0.1 % - ≤ 1 %): hypersensitivity including bronchospasm, pyrexia, pruritus, facial 
oedema and rash maculo-papular or dermatitis bullous. 
 
Metabolism and nutrition disorders: 
Uncommon - rare (≥ 0.01 % - ≤ 1 %): Combination antiretroviral therapy has been associated with 
redistribution of body fat (Lipodystrophy aquired) in HIV patients including the loss of peripheral and 
facial subcutaneous fat, increased intra-abdominal and visceral fat, breast hypertrophy and 
dorsocervical fat accumulation (lipohypertrophy buffalo hump).  
Rare (≥ 0.01 % - ≤ 0.1 %): new onset diabetes mellitus, or exacerbation of existing diabetes mellitus. 
 
Gastrointestinal disorders: 
Uncommon (≥ 0.1 % - ≤ 1 %): vomiting, pancreatitis/blood amylase increased. 
Rare (≥ 0.01 % - ≤ 0.1 %): abdominal distension,  
 
Hepatobiliary disorders: 
Rare (≥ 0.01 % - ≤ 0.1 %): hepatitis, hepatic enzymes increased and jaundice when nelfinavir is used 
in combination with other antiretroviral agents. 
 
Musculoskeletal and connective tissue disorders: 
Rare (≥ 0.01 % - ≤ 0.1 %): Blood creatine phosphokinase increased, myalgia, myositis and 
rhabdomyolysis have been reported with PIs, particularly in combination with nucleoside analogues.  
 

 

 
 

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Vascular disorders: 
Rare (≥ 0.01 % - ≤ 0.1 %): increased spontaneous haemorrhage in patients with haemophilia. 
 
Skin and subcutaneous tissue disorders: 
Very rare (≤ 0.01 %), including isolated reports: Erythema multiforme. 
 
Paediatric population: 
Additional adverse reactions have been reported in the post-marketing experience and are listed below. 
As these data come from the spontaneous reporting system, the frequency of the adverse reactions is 
unknown: hypertriglyceridemia, anaemia, blood lactic acid increased, and pneumonia. 
 
Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk 
factors, advanced HIV disease or long-term exposure to combination antiretroviral therapy (CART). 
The frequency of this is unknown (see section 4.4). 
 
Combination antiretroviral therapy has been associated with metabolic abnormalities such asblood 
triglycerides increased, blood cholesterol increased, insulin resistance, hyperglycaemia and 
hyperlactaemia. The frequency of this is unknown (see section 4.4). 
 
In HIV-infected patients with severe immune deficiency at the time of initiation of combination 
antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic 
infections may arise. The frequency of this is unknown (see section 4.4). 
 
4.9 Overdose 
 
Human experience of acute overdose with VIRACEPT is limited. There is no specific antidote for 
overdose with nelfinavir. If indicated, elimination of unabsorbed nelfinavir should be achieved by 
emesis or gastric lavage. Administration of activated charcoal may also be used to aid removal of 
unabsorbed nelfinavir. Since nelfinavir is highly protein bound, dialysis is unlikely to significantly 
remove it from blood. 
 
Overdoses of nelfinavir could theoretically be associated with prolongation of the QT-interval of the 
ECG (see also section 5.3). Monitoring of overdosed patients is warranted.  
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group:direct acting antivirals, ATC code: J05AE04.  
 
Mechanism of action: HIV protease is an enzyme required for the proteolytic cleavage of the viral 
polyprotein precursors to the individual proteins found in infectious HIV. The cleavage of these viral 
polyproteins is essential for the maturation of infectious virus. Nelfinavir reversibly binds to the active 
site of HIV protease and prevents cleavage of the polyproteins resulting in the formation of immature 
non-infectious viral particles.  
 
Antiviral activity in vitro: the antiviral activity of nelfinavir in vitro has been demonstrated in both 
HIV acute and chronic infections in lymphoblastoid cell lines, peripheral blood lymphocytes and 
monocytes/macrophages. Nelfinavir was found to be active against a broad range of laboratory strains 
and clinical isolates of HIV-1 and the HIV-2 strain ROD. The EC95 (95 % effective concentration) of 
nelfinavir ranged from 7 to 111 nM (mean of 58 nM). Nelfinavir demonstrated additive to synergistic 
effects against HIV in combination with reverse transcriptase inhibitors zidovudine (ZDV), 
lamivudine (3TC), didanosine (ddI), zalcitabine (ddC) and stavudine (d4T) without enhanced 
cytotoxicity. 
 

 

 
 

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Resistance: Viral escape from nelfinavir can occure via viral protease mutations at amino acid 
positions 30, 88 and 90. 
 
In vitro: HIV isolates with reduced susceptibility to nelfinavir have been selected in vitro. HIV isolates 
from selected patients treated with nelfinavir alone or in combination with reverse transcriptase 
inhibitors were monitored for phenotypic (n=19) and genotypic (n=195, 157 of which were assessable) 
changes in clinical trials over a period of 2 to 82 weeks. One or more viral protease mutations at amino 
acid positions 30, 35, 36, 46, 71, 77 and 88 were detected in > 10 % of patients with assessable 
isolates. Of 19 patients for whom both phenotypic and genotypic analyses were performed on clinical 
isolates, 9 patients isolates showed reduced susceptibility (5- to 93-fold) to nelfinavir in vitro. Isolates 
from all 9 patients possessed one or more mutations in the viral protease gene. Amino acid position 30 
appeared to be the most frequent mutation site. 
 
Cross resistance in vitro: HIV isolates obtained from 5 patients during nelfinavir therapy showed a 
5- to 93-fold decrease in nelfinavir susceptibility in vitro when compared to matched baseline isolates 
but did not demonstrate a concordant decrease in susceptibility to indinavir, ritonavir, saquinavir or 
amprenavir in vitro. Conversely, following ritonavir therapy, 6 of 7 clinical isolates with decreased 
ritonavir susceptibility (8- to 113-fold) in vitro compared to baseline also exhibited decreased 
susceptibility to nelfinavir in vitro (5- to 40 fold). An HIV isolate obtained from a patient receiving 
saquinavir therapy showed decreased susceptibility to saquinavir (7- fold) but did not demonstrate a 
concordant decrease in susceptibility to nelfinavir. Cross-resistance between nelfinavir and reverse 
transcriptase inhibitors is unlikely because different enzyme targets are involved. Clinical isolates 
(n=5) with decreased susceptibility to zidovudine, lamivudine, or nevirapine remain fully susceptible 
to nelfinavir in vitro. 
 
In vivo: The overall incidence of the D30N mutation in the viral protease of assessable isolates 
(n=157) from patients receiving nelfinavir monotherapy or nelfinavir in combination with zidovudine 
and lamivudine or stavudine was 54.8 %. The overall incidence of other mutations associated with 
primary PI resistance was 9.6 % for the L90M substitution where as substitutions at 48, 82 and 84 
were not observed. 
 
Clinical pharmacodynamic data: treatment with nelfinavir alone or in combination with other 
antiretroviral agents has been documented to reduce viral load and increase CD4 cell counts in HIV-1 
seropositive patients. Decreases in HIV RNA observed with nelfinavir monotherapy were less 
pronounced and of shorter duration. The effects of nelfinavir (alone or combined with other 
antiretroviral agents) on biological markers of disease activity, CD4 cell count and viral RNA, were 
evaluated in several studies involving HIV-1 infected patients. 
 
The efficacy of the BID regimen has been evaluated versus the TID regimen with VIRACEPT 250 mg 
tablets primarily in patients naïve to PIs. A randomised open-label study compared the HIV RNA 
suppression of nelfinavir 1250 mg BID versus nelfinavir 750 mg TID in PI naïve patients also 
receiving stavudine (30-40 mg BID) and lamivudine (150 mg BID). 
 
Proportion of patients with HIV RNA below LOQ (sensitive and ultrasensitive assays) at Week 48 
Assay Analysis Viracept BID (%) Viracept TID (%) 95 % CI 

Observed data 135/164 (82 %) 146/169 (86 %) (-12, +4) 
LOCF 145/200 (73 %) 161/206 (78 %) (-14, +3) 

 
Sensitive  

ITT (NC = F) 135/200 (68 %) 146/206 (71 %) (-12, +6) 
Observed data 114/164 (70 %) 125/169 (74 %) (-14, +5) 
LOCF 121/200 (61 %) 136/206 (66 %) (-15, +4) 

 
Ultrasensitive  

ITT (NC = F) 114/200 (57 %) 125/206 (61 %) (-13, +6) 
LOCF= Last observation carried forward 
ITT = Intention to Treat 
NC = F: non-completers = failures 
 
The BID regimen produced statistically significantly higher peak nelfinavir plasma levels versus the 
TID regimen. Small, non-statistically significant differences were observed in other pharmacokinetic 
parameters with no trend favouring one regimen over the other. Although study 542 showed no 

 

 
 

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statistically significant differences between the two regimens in efficacy in a predominantly 
antiretroviral naïve patient population, the significance of these findings for antiretroviral experienced 
patients is unknown. 
 
In a study of 297 HIV-1 seropositive patients receiving zidovudine and lamivudine plus nelfinavir 
(2 different doses) or zidovudine and lamivudine alone, the mean baseline CD4 cell count was 
288 cells/mm3 and the mean baseline plasma HIV RNA was 5.21 log10 copies/ml (160,394 copies/ml). 
The mean decrease in plasma HIV RNA using a PCR assay (< 400 copies/ml) at 24 weeks was 
2.33 log10 in patients receiving combination therapy with nelfinavir 750 mg TID, compared to 
1.34 log10 in patients receiving zidovudine and lamivudine alone. At 24 weeks, the percentage of 
patients whose plasma HIV RNA levels had decreased to below the limit of detection of the assay 
(< 400 copies/ml) were 81 % and 8 % for the groups treated with nelfinavir 750 mg TID plus 
zidovudine and lamivudine or zidovudine and lamivudine, respectively. Mean CD4 cell counts at 
24 weeks were increased by 150 and 95 cells/mm3 for the groups treated with nelfinavir 750 mg TID 
plus zidovudine and lamivudine or zidovudine and lamivudine, respectively. At 48 weeks, 
approximately 75 % of the patients treated with nelfinavir 750 mg TID plus zidovudine and 
lamivudine remained below the level of detection of the assay (< 400 copies/ml); mean increase in 
CD4 cell counts was 198 cells/mm3 at 48 weeks in this group. 
 
No important differences in safety or tolerability were observed between the BID and TID dosing 
groups, with the same proportion of patients in each arm experiencing adverse events of any intensity, 
irrespective of relationship to trial medication. 
 
Plasma levels of certain HIV-1 protease inhibitors, which are metabolised predominantly by CYP3A4, 
can be increased by the co-administration of low-dose ritonavir, which is an inhibitor of this 
metabolism. Treatment paradigms for several protease inhibitors, which are subject to this interaction, 
require the co-administration of low-dose ritonavir (‘boosting’) in order to enhance plasma levels and 
optimise antiviral efficacy. Plasma levels of nelfinavir, which is metabolised predominantly by 
CYP2C19 and only partially by CYP3A4, are not greatly increased by co-administration with 
ritonavir, and therefore nelfinavir does not require co-administration with low-dose ritonavir.. Two 
studies have compared the safety and efficacy of nelfinavir (unboosted) with ritonavir- boosted 
protease inhibitors, each in combination with other antiretroviral agents. 
 
Study M98-863 is a randomised, double blind trial of 653 antiretroviral-naïve patients investigating 
lopinavir/ritonavir (400/100 mg BID n=326) compared to nelfinavir (750 mg TID n=327), each in 
combination with lamivudine (150 mg twice daily) and stavudine (40 mg twice daily). Median 
baseline HIV-1 RNA was 4.98 log10 copies/ml and 5.01 log10 copies/ml in the nelfinavir and 
lopinavir/ritonavir treatment groups respectively. Median baseline CD4+ cell count was 232 cells/mm3 
in both groups. At week 48, 63 % nelfinavir and 75 % lopinavir/ritonavir patients had HIV-1 RNA < 
400 copies/ml, whereas 52 % nelfinavir and 67 % lopinavir/ritonavir patients had HIV-1 RNA <50 
copies/ml (intent-to-treat, missing = failure). The mean increase from baseline in CD4+ cell count at 
week 48 was 195 cells/mm3 and 207 cells/mm3 in the nelfinavir and lopinavir/ritonavir groups 
respectively. Through 48 weeks of therapy, a statistically significantly higher proportion of patients in 
the lopinavir/ritonavir arm had HIV-1 RNA < 50 copies/ml compared to the nelfinavir arm.  
 
Study APV30002 is a randomised, open-label trial of 649 antiretroviral treatment naïve patients with 
advanced HIV-disease, investigating fosamprenavir/ritonavir (1400 mg/200 mg QD n=322) compared 
to nelfinavir (1250 mg BID n=327), each in combination with lamivudine (150 mg twice daily) and 
abacavir (300 mg twice daily). Median baseline HIV-1 RNA was 4.8 log10 copies/ml in both treatment 
groups. Median baseline CD4+ cell counts were 177 and 166 x106 cells/l for the nelfinavir and 
fosamprenavir/ritonavir groups respectively. At week 48, non-inferiority was shown with 68 % of 
patients in the group treated with nelfinavir and 69 % patients treated with fosamprenavir/ritonavir 
having plasma HIV-1 RNA <400 copies/ml whereas 53 % in the nelfinavir and 55 % in the 
fosamprenavir/ritonavir patients had HIV-1 RNA <50 copies/ml (intent-to-treat, 
rebound/discontinuation = failure). The median increase from baseline in CD4+ cell count over 48 
weeks was 207 cells/mm3 and 203 cells/mm3 in the nelfinavir and fosamprenavir/ritonavir groups 
respectively. The virological failure was greater in the nelfinavir group (17 %) than in the 

 

 
 

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fosamprenavir/ritonavir group (7 %). Treatment emergent NRTI resistance was significantly less 
frequent with fosamprenavir/ritonavir compared to nelfinavir (13 % versus 57 %; p<0.001). 
 
5.2 Pharmacokinetic properties 
 
The pharmacokinetic properties of nelfinavir have been evaluated in healthy volunteers and 
HIV-infected patients. No substantial differences have been observed between healthy volunteers and 
HIV-infected patients. 
 
Absorption: after single or multiple oral doses of 500 to 750 mg (two to three 250 mg tablets) with 
food, peak nelfinavir plasma concentrations were typically achieved in 2 to 4 hours. 
 
After multiple dosing with 750 mg every 8 hours for 28 days (steady-state), peak plasma 
concentrations (Cmax) averaged 3-4 µg/ml and plasma concentrations prior to the next dose (trough) 
were 1-3 µg/ml. A greater than dose-proportional increase in nelfinavir plasma concentrations was 
observed after single doses; however, this was not observed after multiple dosing. 
 
A pharmacokinetic study in HIV-positive patients compared multiple doses of 1250 mg twice daily 
(BID) with multiple doses of 750 mg three times daily (TID) for 28 days. Patients receiving 
VIRACEPT BID (n=10) achieved nelfinavir Cmax of 4.0 ± 0.8 µg/ml and morning and evening trough 
concentrations of 2.2 ± 1.3 µg/ml and 0.7 ± 0.4 µg/ml, respectively. Patients receiving VIRACEPT 
TID (n=11) achieved nelfinavir peak plasma concentrations (Cmax) of 3.0 ± 1.6 µg/ml and morning and 
evening trough concentrations of 1.4 ± 0.6 µg/ml and 1.0 ± 0.5 µg/ml, respectively. The difference 
between morning and afternoon or evening trough concentrations for the TID and BID regimens was 
also observed in healthy volunteers who were dosed at precise 8- or 12-hour intervals. 
 
The pharmacokinetics of nelfinavir are similar during BID and TID administration. In patients, the 
nelfinavir AUC0-24 with 1250 mg BID administration was 52.8 ± 15.7 µg⋅h/ml (n=10) and with 750 mg 
TID administration was 43.6 ± 17.8 µg⋅h/ml (n=11). Trough drug exposures remain at least twenty 
fold greater than the mean IC95 throughout the dosing interval for both regimens. The clinical 
relevance of relating in vitro measures to drug potency and clinical outcome has not been established. 
A greater than dose-proportional increase in nelfinavir plasma concentrations was observed after 
single doses; however, this was not observed after multiple dosing. 
 
The absolute bioavailability of VIRACEPT has not been determined. 
 
Effect of Food on Oral Absorption 
Food increases nelfinavir exposure and decreases nelfinavir pharmacokinetic variability relative to the 
fasted state. In one study, healthy volunteers received a single dose of 1250 mg of VIRACEPT (5x 
250 mg tablets) under fasted or fed conditions (three meals with different caloric and fat contents). In a 
second study, healthy volunteers received single doses of 1250 mg VIRACEPT (5 x 250 mg tablets) 
under fasted or fed conditions (two meals with different fat content). The results from the two studies 
are summarized below. 
 
Increase in AUC, Cmax and Tmax for Nelfinavir in Fed State Relative to Fasted State Following 
1250 mg VIRACEPT (5 x 250 mg tablets) 
Number of 
Kcal 

% Fat Number of 
subjects 

AUC fold 
increase 

Cmax fold increase Increase in Tmax (hr) 

125 20 n=21 2.2 2.0 1.00 
500 20 n=22 3.1 2.3 2.00 
1000 50 n=23 5.2 3.3 2.00 
 

 

 
 

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Increase in Nelfinavir AUC, Cmax and Tmax in Fed Low Fat (20%) versus High fat (50%) State 
Relative to Fasted State Following 1250 mg VIRACEPT (5 x 250 mg tablets) 
Number of 
Kcal 

% Fat Number of 
Subjects 

AUC fold 
increase 

Cmax fold increase Increase in Tmax (hr) 

500 20 n=22 3.1 2.5 1.8 
500 50 n=22 5.1 3.8 2.1 
 
Nelfinavir exposure increases with increasing calorie or fat content of meals taken with VIRACEPT. 
 
Distribution: Nelfinavir in serum is extensively protein-bound (≥ 98 %). The estimated volumes of 
distribution in both animals and humans is 2-7 l/kg which exceeded total body water and suggests 
extensive penetration of nelfinavir into tissues. 
 
Metabolism: In vitro studies demonstrated that multiple cytochrome P-450 isoforms including 
CYP3A, CYP2C19/C9 and CYP2D6 are responsible for the metabolism of nelfinavir. One major and 
several minor oxidative metabolites were found in plasma. The major oxidative metabolite, M8 (tert-
butyl hydroxy nelfinavir), has in vitro antiviral activity equal to the parent drug and its formation is 
catalysed by the polymorphic cytochrome CYP2C19. The further degradation of M8 appears to be 
catalysed by CYP3A4. In subjects with normal CYP2C19 activity, plasma levels of this metabolite are 
approximately 25 % of the total plasma nelfinavir-related concentration. It is expected that in 
CYP2C19 poor metabolisers or in patients receiving concomitantly strong CYP2C19 inhibitors (see 
section 4.5), nelfinavir plasma levels would be elevated whereas levels of tert-butyl hydroxy nelfinavir 
would be negligible or non-measurable. 
 
Elimination: oral clearance estimates after single doses (24-33 l/h) and multiple doses (26-61 l/h) 
indicate that nelfinavir exhibits medium to high hepatic bioavailability. The terminal half-life in 
plasma was typically 3.5 to 5 hours. The majority (87 %) of an oral 750 mg dose containing 
14C-nelfinavir was recovered in the faeces; total faecal radioactivity consisted of nelfinavir (22 %) and 
numerous oxidative metabolites (78 %). Only 1-2 % of the dose was recovered in urine, of which 
unchanged nelfinavir was the major component. 
 
Pharmacokinetics in special populations: 
 
Children: 
In children between the ages of 2 and 13 years, the clearance of orally administered nelfinavir is 
approximately 2 to 3 times higher than in adults, with large intersubject variability. Administration of 
VIRACEPT oral powder or tablets at a dose of approximately 25-30 mg/kg TID with food achieves 
steady-state plasma concentrations that are similar to those achieved in adult patients receiving 750 mg 
TID.  
 
The pharmacokinetics of nelfinavir have been investigated in 5 studies in paediatric patients from birth 
to 13 years of age. Patients received VIRACEPT either three times daily or twice daily with food or 
with meals. The dosing regimens and associated AUC24 values are summarized below. 
  

 

 
 

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Summary of Steady-state AUC24 of nelfinavir in Paediatric Studies 
 

Protocol No.  Dosing Regimen1  N2  Age  

 
Food taken  

with Viracept 

AUC24 
(mg.hr/L)  

Arithmetic mean 
± SD  

AG1343-524  20 (19-28) mg/kg TID 14  2-13 years  

 
Powder with milk, 

formula, pudding, or 
water, as part  

of a light meal or tablet  
taken with a light meal 

56.1 ± 29.8  

      

PACTG-725  6  3-11 years  With food 101.8 ± 56.1  
 

55 (48-60) mg/kg  
BID      

PENTA 7  4  2-9 months  With milk 33.8 ± 8.9  
 

40 (34-43) mg/kg  
TID      

PENTA 7  12  2-9 months  With milk 37.2 ± 19.2  
 

75 (55-83) mg/kg  
BID      

PACTG-353  40 (14-56) mg/kg BID 10  6 weeks  
Powder with water, 
milk, formula, soy 

formula, soy milk, or 
dietary supplements 

44.1 ± 27.4  

   1 week  45.8 ± 32.1 
1 Protocol specified dose (actual dose range) 
2  N: number of subjects with evaluable pharmacokinetic results 
Ctrough values are not presented in the table because they are not available from all studies 
 
Pharmacokinetic data are also available for 86 patients (age 2 to 12 years) who received VIRACEPT 
25-35 mg/kg TID in Study AG1343-556. The pharmacokinetic data from Study AG1343-556 were 
more variable than data from other studies conducted in the paediatric population; the 95% confidence 
interval for AUC24 was 9 to 121 mg.hr/L. 
 
Overall, use of VIRACEPT in the paediatric population is associated with highly variable drug 
exposure. The reason for this high variability is not known but may be due to inconsistent food intake 
in paediatric patients. 
 
Elderly: 
There are no data available in the elderly. 
 
Hepatic impairment: 
The multi-dose pharmacokinetics of nelfinavir have not been studied in HIV-positive patients with 
hepatic insufficiency. 
Pharmacokinetics of nelfinavir after a single dose of 750 mg was studied in patients with liver 
impairment and healthy volunteers. A 49 %-69 % increase was observed in AUC of nelfinavir in the 
hepatically impaired groups with impairment (Child-Turcotte Classes A to C) compared to the healthy 
group. Specific dose recommendations for nelfinavir cannot be made based on the results of this study. 
A second study evaluated the steady state pharmacokinetics of nelfinavir (1250 mg twice daily for 2 
weeks) in adult HIV-seronegative subjects with mild (Child-Pugh A; n=6) or moderate (Child-Pugh B; 
n=6) hepatic impairment. Compared to control subjects with normal hepatic function, the AUC and 
Cmax of nelfinavir were not significantly different in subjects with mild impairment but were increased 
by 62% and 22%, respectively, in subjects with moderate hepatic impairment. 
 

 

 
 

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5.3 Preclinical safety data 
 
During in vitro studies, cloned human cardiac potassium channels (hERG) were inhibited by high 
concentrations of nelfinavir and its active metabolite M8. hERG potassium channels were inhibited by 
20 % at nelfinavir and M8 concentrations that are about four- to five-fold and seventy-fold, 
respectively, above the average free therapeutic levels in humans. By contrast, no effects suggesting 
prolongation of the QT-interval of the ECG were observed at similar doses in dogs or in isolated 
cardiac tissue. The clinical relevance of these in vitro data is unknown. However, based on data from 
products known to prolong the QT-interval, a block of hERG potassium channels of > 20 % may be 
clinically relevant. Therefore the potential for QT prolongation should be considered in cases of 
overdose (see section 4.9).  
 
Acute and chronic toxicity: oral acute and chronic toxicity studies were conducted in the mouse 
(500 mg/kg/day), rat (up to 1,000 mg/kg/day) and monkey (up to 800 mg/kg/day). There were 
increased liver weights and dose-related thyroid follicular cell hypertrophy in rats. Weight loss and 
general physical decline was observed in monkeys together with general evidence of gastrointestinal 
toxicity.  
 
Mutagenicity: in vitro and in vivo studies with and without metabolic activation have shown that 
nelfinavir has no mutagenic or genotoxic activity. 
 
Carcinogenicity: Two year oral carcinogenicity studies with nelfinavir mesilate were conducted in 
mice and rats. In mice, administration of up to 1000 mg/kg/day did not result in any evidence for an 
oncogenic effect. In rats administration of 1000 mg/kg/day resulted in increased incidences of thyroid 
follicular cell adenoma and carcinoma, relative to those for controls. Systemic exposures were 3 to 4 
times those for humans given therapeutic doses. Administration of 300 mg/kg/day resulted in an 
increased incidence of thyroid follicular cell adenoma. Chronic nelfinavir treatment of rats has been 
demonstrated to produce effects consistent with enzyme induction, which predisposed rats, but not 
humans, to thyroid neoplasms. The weight of evidence indicates that nelfinavir is unlikely to be a 
carcinogen in humans. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
The oral powder contains: 
- microcrystalline cellulose 
- maltodextrin 
- dibasic potassium phosphate 
- crospovidone 
- hydroxypropyl methylcellulose 
- aspartame (E951) 
- sucrose palmitate 
- natural and artificial flavour 
 
6.2 Incompatibilities 
 
This medicinal product must not be mixed with acidic substances due to taste (see section 4.2). 
 
6.3 Shelf life 
 
2 years. 
 
6.4 Special precautions for storage 
 
Store in the original container. Do not store above 30°C. 

 

 
 

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6.5 Nature and contents of container 
 
VIRACEPT 50 mg/g oral powder is provided in HDPE plastic bottles fitted with polypropylene child 
resistant closures with a polyethylene liner. Each bottle contains 144 grams of oral powder and is 
supplied with a 1 gram (white) and a 5 gram (blue) polypropylene scoop.  
 
6.6 Special precautions for disposal and other handling 
 
There are two scoops provided in the box, a white 1 gram scoop and a blue 5 gram scoop. 
1. Measure out a level scoop of powder by using the handle of the second scoop to scrape off the 

extra powder.  
2. mix powder with water, milk, formula, soy milk, dietary supplements or pudding 
3. do not mix powder with acidic food or juice 
4. powder mixed in the media as described under 2 is recommended to be used within 6 hours 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Roche Registration Limited 
6 Falcon Way 
Shire Park 
Welwyn Garden City 
AL7 1TW 
United Kingdom 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/97/054/001 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 22 January 1998 
Date of latest renewal: 23 January 2008 
 
 
10. DATE OF REVISION OF THE TEXT 
 
 

 

 
 

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1. NAME OF THE MEDICINAL PRODUCT 
 
VIRACEPT 250 mg film-coated tablets. 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each film-coated tablet contains nelfinavir mesilate corresponding to 250 mg of nelfinavir. 
 
Excipients: 
For a full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Blue, oblong biconvex film-coated tablets. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
VIRACEPT is indicated in antiretroviral combination treatment of human immunodeficiency virus 
(HIV-1) infected adults, adolescents and children of 3 years of age and older.  
 
In protease inhibitor (PI) experienced patients the choice of nelfinavir should be based on individual 
viral resistance testing and treatment history. 
 
See section 5.1.  
 
4.2 Posology and method of administration 
 
Therapy with VIRACEPT should be initiated by a physician experienced in the management of HIV 
infection. 
 
VIRACEPT is administered orally and should always be ingested with food (see section 5.2). 
 
Patients older than 13 years: the recommended dose of VIRACEPT 250 mg film-coated tablets is 
1250 mg (five tablets) twice a day (BID) or 750 mg (three tablets) three times a day (TID) by 
mouth. 
The efficacy of the BID (twice daily) regimen has been evaluated versus the TID (three times daily) 
regimen primarily in patients naïve to PIs (see section 5.1). 
 
Patients aged 3 to 13 years: for children, the recommended starting dose is 50-55 mg/kg BID or, if 
using a TID regimen, 25 – 35 mg/kg body weight per dose.  
 
The recommended dose of VIRACEPT film-coated tablets to be administered BID to children aged 3 
to 13 years is as follows: 
 

Dose to be administered two times a day to children aged 3 to 13 
Body weight of the patient Number of VIRACEPT 250 mg 

in kg film-coated tablets per dose* 
18 to 22 kg  4 
over 22 kg 5 

 

 

 
 

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The recommended dose of VIRACEPT film-coated tablets to be administered TID to children aged 3 
to 13 years is shown in the table below. Children with weights between 10.5–12 kg, 12–14 kg and 
18–22 kg will receive a different number of tablets with each meal.  The table provides a schedule 
assuring that the appropriate total daily dose of Viracept is taken each day based on the child’s weight. 
 
The prescriber should advise the caregiver to carefully monitor increases in weight of the child to 
ensure that the appropriate total daily dose is taken. The prescriber should also advise the caregiver 
about the importance of adhering to the dosing instructions and that the appropriate number of tablets 
should be taken at each dose with a meal. 
 

Dose to be administered three times a day to children aged 3 to 13 
Recommended number of tablets at each 

meal 
Body weight of 
the patient in 

kg Number of 
tablets at 
breakfast 

Number of 
tablets at 

lunch 

Number of 
tablets at 

dinner 

Total number 
of tablets per 

day 

  7.5 to 8.5 kg 1 1 1 3 
  8.5 to 10.5 kg 1 1 1 3 
10.5 to 12 kg* 2 1 1 4 
12    to 14 kg* 2 1 2 5 
14    to 16 kg 2 2 2 6 
16    to 18 kg 2 2 2 6 
18    to 22 kg* 3 2 2 7 
    over 22 kg 3 3 3 9 
* Children with these weights will be given an uneven number of tablets during the 
    day. The virologic and immunologic responses should be monitored to assure 
    these children achieve response to therapy. 
 
For patients unable to swallow the tablets, VIRACEPT tablets may be dispersed in a half cup of water 
while thoroughly stirring with a spoon. Once dispersed, the cloudy bluish liquid should be thoroughly 
mixed and consumed immediately. The glass should be rinsed with a half cup of water and the rinse 
should be swallowed to ensure that the entire dose is consumed.  
 
Acidic food or juice (e.g. orange juice, apple juice or apple sauce) are not recommended to be used in 
combination with VIRACEPT, because the combination may result in a bitter taste. The VIRACEPT 
suspension should be taken with a meal.  
 
The prescriber should assure that the caregiver understands the importance of monitoring adherence 
and the appropriate method to prepare and administer Viracept tablets to children in each weight band. 
 
Renal and hepatic impairment: there are no data specific for HIV positive patients with renal 
impairment and therefore specific dosage recommendations cannot be made (see section 4.4). 
Nelfinavir is principally metabolised and eliminated by the liver. There are not sufficient data from 
patients with liver impairment and therefore specific dose recommendations cannot be made (see 
section 5.2). Caution should be used when administering VIRACEPT to patients with impaired renal 
or hepatic function. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients. 
 
Co-administration with medicinal products with narrow therapeutic windows and which are substrates 
of CYP3A4 [e.g., terfenadine, astemizole, cisapride, amiodarone, quinidine, pimozide, triazolam, 
orally administered midazolam (for caution on parenterally administered midazolam, see section 4.5), 
ergot derivatives, lovastatin and simvastatin, alfuzosin, and sildenafil when used for treatment of 

 

 
 

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pulmonary arterial hypertension hypertension (for the use of sildenafil and other PDE-5 inhibitors in 
patients with erectile dysfunction, see section 4.5)]. 
 
Potent inducers of CYP3A (e.g., rifampicin, phenobarbital and carbamazepine) reduce nelfinavir 
plasma concentrations.  
Co- administration with rifampicin is contra-indicated due to a reduction in exposure to nelfinavir.  
Physicians should not use potent inducers of CYP 3A4 in combination with Viracept and should 
consider using alternatives when a patient is taking VIRACEPT (see section 4.5). 
 
Herbal preparations containing St. John’s wort (Hypericum perforatum) must not be used while taking 
nelfinavir due to the risk of decreased plasma concentrations and reduced clinical effects of nelfinavir 
(see section 4.5).  
 
VIRACEPT should not be co-administered with omeprazole due to a reduction in exposure to 
nelfinavir and its active metabolite M8 (Tert-butyl hydroxy nelfinavir). This may lead to a loss of 
virologic response and possible resistance to VIRACEPT (see section 4.5). 
 
4.4 Special warnings and precautions for use 
 
Patients should be instructed that VIRACEPT is not a cure for HIV infection, that they may continue 
to develop infections or other illnesses associated with HIV disease, and that VIRACEPT has not been 
shown to reduce the risk of transmission of HIV disease through sexual contact or blood 
contamination. 
 
Immune Reactivation Syndrome: In HIV-infected patients with severe immune deficiency at the time 
of institution of combination antiretroviral therapy (CART), an inflammatory reaction to 
asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or 
aggravation of symptoms. Typically, such reactions have been observed within the first few weeks or 
months of initiation of CART. Relevant examples are cytomegalovirus retinitis, generalised and/or 
focal mycobacterium infections, and Pneumocystis carinii pneumonia. Any inflammatory symptoms 
should be evaluated and treatment instituted when necessary. 
 
Liver Disease: The safety and efficacy of nelfinavir has not been established in patients with 
significant underlying liver disorders. Patients with chronic hepatitis B or C and treated with 
combination antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic 
adverse events. In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the 
relevant product information for these medicinal products. 
Patients with pre-existing liver dysfunction including chronic active hepatitis have an increased 
frequency of liver function abnormalities during combination antiretroviral therapy and should be 
monitored according to standard practice. If there is evidence of worsening liver disease in such 
patients, interruption or discontinuation of treatment must be considered. The use of nelfinavir in 
patients with moderate hepatic impairment has not been studied. In the absence of such studies, 
caution should be exercised, as increases in nelfinavir levels and/or increases in liver enzymes may 
occur. 
Patients with hepatic impairment should not be given colchicine with VIRACEPT. 
 
Osteonecrosis: Although the aetiology is considered to be multifactorial (including corticosteroid use, 
alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis 
have been reported particularly in patients with advanced HIV-disease and/or long-term exposure to 
combination antiretroviral therapy (CART). Patients should be advised to seek medical advice if they 
experience joint aches and pain, joint stiffness or difficulty in movement. 
 
Renal Impairment: Since nelfinavir is highly bound to plasma proteins, it is unlikely that it will be 
significantly removed by haemodiaylisis or peritoneal dialysis. Therefore, no special precautions or 
dose adjustments are required in these patients. 
Patients with renal impairment should not be given colchicine with VIRACEPT. 
 

 

 
 

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Diabetes mellitus and hyperglycaemia: New onset diabetes mellitus, hyperglycaemia or exacerbation 
of existing diabetes mellitus has been reported in patients receiving PIs. In some of these the 
hyperglycaemia was severe and in some cases also associated with ketoacidosis. Many patients had 
confounding medical conditions, some of which required therapy with agents that have been 
associated with the development of diabetes or hyperglycaemia. 
 
Patients with haemophilia: There have been reports of increased bleeding, including spontaneous skin 
haematomas and haemarthroses, in haemophiliac patients type A and B treated with PIs. In some 
patients additional factor VIII was given. In more than half of the reported cases, treatment with PIs 
was continued or reintroduced if treatment had been discontinued. A causal relationship has been 
evoked, although the mechanism of action has not been elucidated. Haemophiliac patients should 
therefore be made aware of the possibility of increased bleeding. 
 
Lipodystrophy: Combination antiretroviral therapy has been associated with the redistribution of body 
fat (acquired lipodystrophy) in HIV patients. The long-term consequences of these events are currently 
unknown. Knowledge about the mechanism is incomplete. A connection between visceral lipomatosis 
and PIs and lipoatrophy and nucleoside analogue reverse transcriptase inhibitors (NRTIs) has been 
hypothesised. A higher risk of lipodystrophy has been associated with individual factors such as older 
age, and with drug related factors such as longer duration of antiretroviral treatment and associated 
metabolic disturbances. Clinical examination should include evaluation for physical signs of fat 
redistribution. Consideration should be given to the measurement of fasting serum lipids and blood 
glucose. Lipid disorders should be managed as clinically appropriate (see section 4.8). 
 
PDE5 inhibitors: particular caution should be used when prescribing sildenafil, tadalafil or vardenafil 
for the treatment of erectile dysfunction in patients receiving VIRACEPT.  Co-administration of 
VIRACEPT with these medicinal products is expected to increase their concentrations and may result 
in associated adverse events such as hypotension, syncope, visual changes and prolonged erection (see 
section 4.5). Concomitant use of sildenafil prescribed for the treatment of pulmonary arterial 
hypertension with VIRACEPT is contraindicated (see section 4.3). 
 
HMG-CoA reductase inhibitors (statins): HMG-CoA reductase inhibitors may interact with 
protease inhibitors and increase the risk of myopathy, including rhabdomyolysis. Concomitant use of 
protease inhibitors with lovastatin or simvastatin is contraindicated. Other HMG-CoA reductase 
inhibitors may also interact with protease inhibitors and should be used with caution.  
 
Concurrent administration of salmeterol with VIRACEPT is not recommended. The combination may 
result in increased risk of cardiovascular adverse events associated with salmeterol, including QT 
prolongation, palpitations and sinus tachycardia.  
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Nelfinavir is primarily metabolised via the cytochrome P450 isoenzymes CYP3A4 and CYP2C19 (see 
section 5.2). Nelfinavir is also an inhibitor of CYP 3A4. Based on in vitro data, nelfinavir is unlikely 
to inhibit other cytochrome P450 isoforms at concentrations in the therapeutic range. 
 
Combination with other medicinal products: Caution is advised whenever VIRACEPT is co-
administered with agents that are inducers or inhibitors and/or substrates of CYP3A4; such 
combinations may require dose adjustment (see also sections 4.3 and 4.8). 
 
Substrates for CYP3A: Co-administration is contraindicated with the following agents that are 
substrates for CYP3A4 and that have narrow therapeutic windows terfenadine, astemizole, cisapride, 
amiodarone, quinidine, ergot derivatives, pimozide, oral midazolam, triazolam, alfuzosin, and 
sildenafil when used to treat pulmonary arterial hypertension (see section 4.3). 
 
Co-administration of a PI with sildenafil is expected to substantially increase sildenafil concentration 
and may result in an increase in sildenafil associated adverse events, including hypotension, visual 
changes, and priapism. 

 

 
 

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For other substrates of CYP3A4 a dose reduction or consideration of an alternative may be required 
(Table 1).  
Coadministration of nelfinavir with fluticasone proprionate may increase plasma concentrations of 
fluticasone propionate. Consider alternatives that are not metabolised by CYP3A4 such as 
beclomethasone. 
Concomitant use of trazodone and nelfinavir may increase plasma concentrations of trazodone and a 
lower dose of trazodone should be considered. 
 
Coadministration of nelfinavir with simvastatin or lovastatin may result in significant increases in 
simvastatin and lovastatin plasma concentrations and is contraindicated (see section 4.3). Consider 
alternatives that are not substrates of CYP3A4 such as pravastatin or fluvastatin. Other HMG-CoA 
reductase inhibitors may also interact with protease inhibitors and should be used with caution .  
 
Concurrent administration of salmeterol with VIRACEPT is not recommended. The combination may 
result in increased risk of cardiovascular adverse events associated with salmeterol, including QT 
prolongation, palpitations and sinus tachycardia.  
Coadministration of warfarin and VIRACEPT may affect concentrations of warfarin. It is 
recommended that the international normalized ratio (INR) be monitored carefully during treatment 
with VIRACEPT, especially when commencing therapy. 
 
Metabolic enzyme inducers: Potent inducers of CYP3A4 (e.g., rifampicin, pehnobarbital and 
carbamazepine) may reduce nelfianvir plasma concentrations and their coadministration is 
contraindicated (see section 4.3). Caution should be used when co-administering other agents that 
induce CYP3A4.  
Plasma concentrations of midazolam are expected to be significantly higher when midazolam is given 
orally and should therefore not be coadministered with nelfinavir.  Parenteral midazolam should be 
coadministered with nelfinavir in an intensive care unit to ensure close clinical monitoring. Dose 
adjustment for midazolam should be considered if more than a single dose is administered (Table 1) 
 
Metabolic enzyme inhibitors: Co-administration of nelfinavir with inhibitors of CYP2C19 (e.g., 
fluconazole, fluoxetine, paroxetine, lansoprazole, imipramine, amitriptyline and diazepam) may be 
expected to reduce the conversion of nelfinavir to its major active metabolite M8 (tert-butyl hydroxy 
nelfinavir) with a concomitant increase in plasma nelfinavir levels (see section 5.2). Limited clinical 
trial data from patients receiving one or more of these medicinal products with nelfinavir indicated 
that a clinically significant effect on safety and efficacy is not expected. However, such an effect 
cannot be ruled out.  
 
Interactions of nelfinavir with selected agents that describe the impact of nelfinavir on the 
pharmacokinetics of the co-administered compound and the impact of other drugs on 
pharmacokinetics of nelfinavir are listed in Table 1. 
 

 

 
 

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Table 1: Interactions and dose recommendations with other medical products 
Medicinal product by 
therapeutic areas 
(dose of nelfinavir 
used in study) 

 
Effects on drug levels 
% Change 

 
Recommendations concerning 
coadministration 

 
NRTIs 
  Clinically significant interactions 

have not been observed between 
nelfinavir and nucleoside 
analogues. At present, there is no 
evidence of inadequate efficacy 
of zidovudine in the CNS that 
could be associated with the 
modest reduction in plasma levels 
of zidovudine when co-
administered with nelfinavir. 
Since it is recommended that 
didanosine be administered on an 
empty stomach, VIRACEPT 
should be administered (with 
food) one hour after or more than 
2 hours before didanosine. 

Protease Inhibitors 
Ritonavir 500 mg single dose 
(nelfinavir 750 mg tid 6 days) 

Ritonavir AUC ↔ 
Ritonavir Cmax ↔ 
Nelfinavir concentrations not 
measured 

No dosage adjustment for needed 
for either product 

Ritonavir 500 mg BID, 3 doses 
(nelfinavir 750 single dose) 

Ritonavir concentrations not 
measured 
Nelfinavir AUC ↑ 152 %  
  

No dosage adjustment for needed 
for either product 

Ritonavir 100 mg or 200 mg BID 
(nelfinavir 1250 mg BID morning 
administration) 

Ritonavir concentrations not 
measured 
Nelfinavir AUC ↑ 20% 
M8 metabolite AUC ↑ 74% 

Ritonavir 100 mg or 200 mg BID 
(nelfinavir 1250 mg BID evening 
administration) 

Ritonavir concentrations not 
measured 
Nelfinavir AUC ↑ 39 % 
M8 metabolite AUC ↑ 86% 

There were no significant 
differences between low doses of 
ritonavir (either 100 or 
200 mg BID) for effects on AUCs 
of nelfinavir and M8. The clinical 
relevance of these findings has 
not been established. 

Indinavir 800 mg single dose 
(nelfinavir 750 mg TID X 7 days) 

Indinavir AUC ↑ 51% 
Indinavir Cmax ↔ 
Nelfinavir concentrations not 
measured 

Indinavir 800 mg Q8H X 7 days 
(nelfinavir 750 mg single dose) 

Indinavir concentrations not 
measured 
Nelfinavir AUC ↑ 83% 

The safety of the combination 
indinavir + nelfinavir has not 
been established 

Saquinavir 1200 mg single dose 
(nelfinavir 750 mg TID X 4 days) 

Saquinavir AUC ↑ 392%  
Nelfinavir concentrations not 
measured 

 

Saquinavir 1200 mg TID 
(nelfinavir 750 mg single dose) 

Saquinavir concentrations not 
measured 
Nelfinavir AUC ↑ 30% 
 

 

Amprenavir 800 mg TID 
(nelfinavir 750 mg TID) 

Amprenavir AUC ↔ 
Amprenavir Cmin ↑ 189 %  
Nelfinavir AUC ↔ 
 

No dosage adjustment for needed 
for either product 

Non-nucleoside Analogue Reverse Transcriptase Inhibitors (NNRTIs) 
Efavirenz 600 mg QD 
(Nelfinavir 750 mg TID) 

Efavirenz AUC ↔ 
Nelfinavir AUC ↓ 20 %  
 

No dosage adjustment for needed 
for either product 

 

 
 

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Medicinal product by 
therapeutic areas 
(dose of nelfinavir 
used in study) 

 
Effects on drug levels 
% Change 

 
Recommendations concerning 
coadministration 

Delavirdine 400 mg TID 
(Nelfinavir 750 mg TID) 

Delavirdine AUC ↓ 31 % 
Nelfinavir AUC ↑ 107 % 
 

Safety of combination not 
established; combination not 
recommended 

Nevirapine  
 

 Dose adjustment is not needed 
when nevirapine is administered 
with nelfinavir. 

Anti infective Agents 
Rifabutin 300 mg QD 
(Nelfinavir 750 mg TID) 

Rifabutin AUC ↑ 207 % 
Nelfinavir AUC ↓ 32 % 

Dosage reduction of rifabutin to 
150 mg QD is necessary when 
nelfinavir 750 mg TID or 
1250 mg BID and rifabutin are 
co-administered. 

Rifabutin 150 mg QD 
(Nelfinavir 750 mg TID) 

Rifabutin AUC ↑ 83 % 
Nelfinavir AUC ↓ 23 % 

Dosage reduction of rifabutin to 
150 mg QD is necessary when 
nelfinavir 750 mg TID or 
1250 mg BID and rifabutin are 
co-administered 

Rifampicin 600 mg qd x 7 days 
(Nelfinavir 750 mg q8h x 5-6 days) 

Rifampicin concentrations not 
measured 
Nelfinavir AUC ↓82%  

Concomitant use of rifampicin is 
contraindicated with nelfinavir 

Ketoconazole  Ketoconazole concentrations not 
measured 
Nelfinavir AUC ↑35%  
  
  

Coadministration of nelfinavir 
and a strong inhibitor of CYP3A, 
ketoconazole, resulted in a 35 % 
increase in nelfinavir plasma 
AUC.The changes in nelfinavir 
concentrations are not considered 
clinically significant and no dose 
adjustment is needed when 
ketoconazole and nelfinavir are 
co-administered.  

Oral Contraceptives 
17 α-Ethinyl estradiol 35 μg qd x 
15 days 
(Nelfinavir 750 mg q8h x 7 days) 

Ethinyl estradiol AUC ↓47%  
Nelfinavir concentrations not 
measured 

Contraceptives with ethinyl 
estradiol should not be 
coadministered with nelfinavir. 
Alternative contraceptive 
measures should be considered. 

Norethindrone 0.4 mg qd x 15 days 
(Nelfinavir 750 mg q8h x 7 days) 

Norethindrone AUC ↓18% 
Nelfinavir concentrations not 
measured 
 

Contraceptives with 
norethindrone should not be 
coadministered with nelfinavir. 
Alternative contraceptive 
measures should be considered. 

HMG-CoA reductase inhibitors (Statins) 
  Since increased concentrations of 

HMG-CoA reductase inhibitors 
may cause myopathy, including 
rhabdomyolysis, the combination 
of these medicinal products with 
nelfinavir is not recommended. 

 

 
 

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Medicinal product by 
therapeutic areas 
(dose of nelfinavir 
used in study) 

 
Effects on drug levels 
% Change 

 
Recommendations concerning 
coadministration 

Simvastatin  or lovastatin 
(Nelfinavir 1250 mg bid) 
 

Simvastatin AUC ↑ 505 % 
Nelfinavir  AUC ↔ 
concentrations not measured 
 

Combination of simvastatin or  
lovastatin and nelfinavir is 
contraindicated (see 
contraindication).  

Atorvastatin 10 mg qd 
(Nelfinavir 1250 mg bid) 

Atorvastatin AUC ↑ 74 % 
Nelfinavir AUC concentrations 
not measured 

Atorvastatin is less dependent on 
CYP3A4 for metabolism. When 
used with nelfinavir, the lowest 
possible dose of atorvastatin 
should be administered.  
 

Pravastatin, fluvastatin, 
rosuvastatin 

 The metabolism of pravastatinand 
fluvastatinis not dependent  on 
CYP3A4, and interactions are not 
expected with nelfinavir. If 
treatment with HMG-CoA 
reductase inhibitors is indicated 
in combination with nelfinavir, 
pravastatin or fluvastatin are 
recommended. Rosuvastatin may 
also be administered with 
nelfinavir but patients should be 
monitored. 

Anticonvulsants 
Phenytoin 300 mg qd x 7 days 
(Nelfinavir 1250 mg bid x 14 days) 

Phenytoin AUC ↓29%  
Free Phenytoin ↓28% 

No dose adjustment for nelfinavir 
is recommended. Nelfinavir may 
lead to decreased AUC of 
phenytoin; therefore phenytoin 
concentrations should be 
monitored during concomitant 
use with nelfinavir.  

Proton Pump Inhibitors 
Omeprazole 20 mg bid x 4 days 
administered 30 minutes before 
nelfinavir 
(Nelfinavir 1250 mg bid x 4 days) 

Omeprazole concentrations not 
measured 
Nelfinavir AUC ↓36%  
Nelfinavir Cmax ↓37%  
Nelfinavir Cmin ↓39%  
M8 metabolite AUC ↓92% 
M8 metabolite Cmax ↓ 89% 
M8 metabolite Cmin ↓ 75% 

Omeprazole should not be co-
administered with nelfinavir. The 
absorption of nelfinavir may be 
reduced in situations where the 
gastric pH is increased 
irrespective of cause. Co-
administration of nelfinavir with 
omeprazole may lead to a loss of 
virologic response and therefore 
concomitant use is contra-
indicated. Caution is 
recommended when nelfinavir is 
co-administered with other proton 
pump inhibitors 

 

 
 

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Medicinal product by 
therapeutic areas 
(dose of nelfinavir 
used in study) 

 
Effects on drug levels 
% Change 

 
Recommendations concerning 
coadministration 

Sedatives/Anxiolytics 
Midazolam No drug interaction study has 

been performed for the co-
administration of nelfinavir with 
benzodiazepines. 

Midazolam is extensively 
metabolised by CYP3A4. Co-
administration of midazolam with 
nelfinavir may cause a large 
increase in the concentration of 
this benzodiazepine. Based on 
data for other CYP3A4 inhibitors, 
plasma concentrations of 
midazolam are expected to be 
significantly higher when 
midazolam is given orally. 
Therefore nelfinavir should not 
be co-administered with orally 
administered midazolam. If 
nelfinavir is co-administered with 
parenteral midazolam, it should 
be done in an intensive care unit 
(ICU) or similar setting which 
ensures close clinical monitoring 
and appropriate medical 
management in case of 
respiratory depression and/or 
prolonged sedation. Dosage 
adjustment for midazolam should 
be considered, especially if more 
than a single dose of midazolam 
is administered 

H1 Receptor Antagonists, 5-HT Agonists 
Terfenadine, astemizole, cisapride Nelfinavir increases terfenadine 

plasma concentrations. Similar 
interactions are likely with 
astemizole and cisapride. 

Nelfinavir must not be 
administered concurrently with 
terfenadine, astemizole or 
cisapride because of the potential 
for serious and/or life-threatening 
cardiac arrhythmias. 

Endothelin receptor antagonists 
Bosentan Not studied. Concomitant use of 

bosentan and nelfinavir may 
increase plasma levels of 
bosentan. 

When administered 
concomitantly with nelfinavir, the 
patient’s tolerability of bosentan 
should be monitored. 

Analgesics 
Methadone 80 mg + 21 mg qd > 1 
month 
(Nelfinavir 1250mg bid x 8 days 

Methadone AUC ↓47%  
 

None of the subjects experienced 
withdrawal symptoms in this 
study; however, due to the 
pharmacokinetic changes, it 
should be expected that some 
patients who received this 
combination may experience 
withdrawal symptoms and require 
an upward adjustment of the 
methadone dose.  
Methadone AUC may be 
decreased when co-administered 
with nelfinavir; therefore upward 
adjustment of methadone dose 
may be required during 
concomitant use with nelfinavir. 

 

 
 

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Medicinal product by 
therapeutic areas 
(dose of nelfinavir 
used in study) 

 
Effects on drug levels 
% Change 

 
Recommendations concerning 
coadministration 

Inhaled/nasal steroid 
↑Fluticasone ↑ Fluticasone Concomitant use of fluticasone 

propionate and VIRACEPT may 
increase plasma concentrations of 
fluticasone propionate. Use with 
caution. Consider alternatives to 
fluticasone propionate, that are 
not metabolised by CYP3A4, 
such as beclometasone, 
particularly for long-term use. 

Antidepressants 
Trazodone  ↑ Trazodone  Concomitant use of trazodone 

and VIRACEPT may increase 
plasma concentrations of 
trazodone. The combination 
should be used with caution and a 
lower dose of trazodone should 
be considered. 

PDE-5 inhibitors for the treatment of pulmonary arterial hypertension (PAH) 
Tadalafil Not studied. Concomitant use of 

tadalafil and nelfinavir may 
increase plasma levels of 
tadalafil.  

Co-administration of tadalafil for 
the treatment of pulmonary 
arterial hypertension with 
Viracept is not recommended. 

Sildenafil Not studied. Concomitant use of 
sildenafil and nelfinavir may 
increase plasma levels of 
sildenafil. 

Sildenafil is contraindicated when 
coadministered with VIRACEPT 
(see contraindications). 

PDE-5 inhibitors for the treatment of erectile dysfunction (ED) 
Tadalafil Not studied. Concomitant use of 

tadalafil and nelfinavir may 
increase plasma levels of 
tadalafil.  

Use with increased monitoring 
for adverse events associated with 
increased exposure to tadalafil. 

Sildenafil Not studied. Concomitant use of 
sildenafil and nelfinavir may 
increase plasma levels of 
sildenafil. 

Sildenafil at a starting dose not 
exceeding 25 mg in 48 hours.  
Use with increased monitoring 
for adverse events associated with 
increased exposure to sildenafil. 

Vardenafil Not studied. Concomitant use of 
vardenafil and nelfinavir may 
increase plasma levels of 
vardenafil 

Use with increased monitoring 
for adverse events associated with 
increased exposure to vardenafil. 

Antigout preparation 
Colchicine Not studied. Concomitant use of 

colchicine and nelfinavir may 
increase plasma levels of 
colchicine 

A reduction in colchicine dosage 
or an interruption of colchicine 
treatment is recommended in 
patients with normal renal or 
hepatic function if treatment with 
nelfinavir is required. Patients 
with renal or hepatic impairment 
should not be given colchicine 
with nelfinavir (see section 4.4). 

 

 
 

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Medicinal product by 
therapeutic areas 
(dose of nelfinavir 
used in study) 

 
Effects on drug levels 
% Change 

 
Recommendations concerning 
coadministration 

Herbal Products 
St. John’s wort Plasma levels of nelfinavir can be 

reduced by concomitant use of 
the herbal preparation St. John’s 
wort (Hypericum perforatum). 
This is due to induction of drug 
metabolising enzymes and/or 
transport proteins by St. John’s 
wort. 

Herbal preparations containing 
St. John’s wort must not be used 
concomitantly with nelfinavir. If 
a patient is already taking 
St. John’s wort, stop St. John’s 
wort, check viral levels and if 
possible nelfinavir levels. 
Nelfinavir levels may increase on 
stopping St. John’s wort, and the 
dose of nelfinavir may need 
adjusting. The inducing effect of 
St. John’s wort may persist for at 
least 2 weeks after cessation of 
treatment. 

↑ Indicates increase, ↓ indicates decrease, ↔ indicates minimal change (< 10 %) 
 
4.6 Fertility, pregnancy and lactation 
 
No treatment-related adverse reactions were seen in animal reproductive toxicity studies in rats at 
doses providing systemic exposure comparable to that observed with the clinical dose. Clinical 
experience in pregnant women is limited. VIRACEPT should be given during pregnancy only if the 
expected benefit justifies the possible risk to the foetus. 
 
It is recommended that HIV-infected women must not breast-feed their infants under any 
circumstances in order to avoid transmission of HIV. Studies in lactating rats showed that nelfinavir is 
excreted in breast milk. There is no data available on nelfinavir excretion into human breast milk. 
Mothers must be instructed to discontinue breast-feeding if they are receiving VIRACEPT. 
 
4.7 Effects on ability to drive and use machines 
 
VIRACEPT has no or negligible influence on the ability to drive and use machines. 
 
4.8 Undesirable effects 
 
The safety of the VIRACEPT 250 mg tablet was studied in controlled clinical trials with over 1300 
patients. The majority of patients in these studies received either 750 mg TID either alone or in 
combination with nucleoside analogues or 1250 mg BID in combination with nucleoside analogues. 
The following adverse events with an at least possible relationship to nelfinavir (i.e. adverse reactions) 
were reported most frequently: diarrhoea, nausea, and rash. Within each frequency grouping, 
undesirable effects are presented in order of decreasing seriousness. 
 
Adverse reactions from clinical trials with nelfinavir 
 
Adverse reactions in clinical studies are summarised in Table 2. The list also includes marked 
laboratory abnormalities that have been observed with nelfinavir (at 48 weeks). 
 

 

 
 

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Table 2: Incidences of Adverse Reactions and marked laboratory abnormalities from the phase 
II and phase III studies. (Very common (≥ 10 %); common (≥ 1 % and < 10 %) 

Body System 
Frequency of Reaction 

Adverse Reactions 

 Grades 3&4 All Grades 
Gastrointestinal disorders 
Very common  Diarrhoea 
Common  Nausea, flatulence,  
Skin and subcutaneous tissue disorders 
Common  Rash 
Investigations 
Common  Increased alanine aminotransferase, 

increased aspartate aminotransferase, 
neutropenia, blood creatinine 
phosphokinase increased, neutrophil 
count decreased 
 

 
Children and neonates: 
A total of approximately 400 patients received nelfinavir in paediatric treatment trials (Studies 524, 
556, PACTG 377/725, and PENTA-7) for up to 96 weeks. The adverse reaction profile seen during 
paediatric clinical trials was similar to that for adults. Diarrhoea was the most commonly reported 
adverse event in children. Neutropenia/leukopenia was the most frequently observed laboratory 
abnormality. During these trials less than 13% of patients in total discontinued treatment due to 
adverse events.  
 
Post-marketing experience with nelfinavir 
Serious and non-serious adverse reactions from post-marketing spontaneous reports (where nelfinavir 
was taken as the sole protease inhibitor or in combination with other antiretroviral therapy), not 
mentioned previously in section 4.8, for which a causal relationship to nelfinavir cannot be excluded, 
are summarised below. As these data come from the spontaneous reporting system, the frequency of 
the adverse reactions is not confirmed. 
 
Immune system disorders: 
Uncommon (≥ 0.1 % - ≤ 1 %): hypersensitivity including bronchospasm, pyrexia, pruritus, facial 
oedema and rash maculo-papular or dermatitis bullous. 
 
Metabolism and nutrition disorders: 
Uncommon - rare (≥ 0.01 % - ≤ 1 %): Combination antiretroviral therapy has been associated with 
redistribution of body fat (Lipodystrophy acquired) in HIV patients including the loss of peripheral 
and facial subcutaneous fat, increased intra-abdominal and visceral fat, breast hypertrophy and 
dorsocervical fat accumulation (lypohypertrophy buffalo hump).  
Rare (≥ 0.01 % - ≤ 0.1 %): new onset diabetes mellitus, or exacerbation of existing diabetes mellitus. 
 
Gastrointestinal disorders: 
Uncommon (≥ 0.1 % - ≤ 1 %): vomiting, pancreatitis/blood amylase increased. 
Rare (≥ 0.01 % - ≤ 0.1 %): abdominal distension,  
 
Hepatobiliary disorders: 
Rare (≥ 0.01 % - ≤ 0.1 %): hepatitis, hepatic enzymes increased and jaundice when nelfinavir is used 
in combination with other antiretroviral agents. 
 
Musculoskeletal and connective tissue disorders: 
Rare (≥ 0.01 % - ≤ 0.1 %): Blood creatine phosphokinase increased, myalgia, myositis and 
rhabdomyolysis have been reported with PIs, particularly in combination with nucleoside analogues.  
 

 

 
 

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Vascular disorders: 
Rare (≥ 0.01 % - ≤ 0.1 %): increased spontaneous haemorrhage bleeding in patients with haemophilia. 
 
Skin and subcutaneous tissue disorders: 
Very rare (≤ 0.01 %), including isolated reports: Erythema multiforme. 
 
Paediatric population: 
Additional adverse reactions have been reported in the post-marketing experience and are listed below. 
As these data come from the spontaneous reporting system, the frequency of the adverse reactions is 
unknown: hypertriglyceridemia, anaemia, blood lactic acid increased, and pneumonia. 
 
Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk 
factors, advanced HIV disease or long-term exposure to combination antiretroviral therapy (CART). 
The frequency of this is unknown (see section 4.4). 
 
Combination antiretroviral therapy has been associated with metabolic abnormalities such asblood 
triglycerides increased, blood cholesterol increased, insulin resistance, hyperglycaemia and 
hyperlactaemia. The frequency of this is unknown (see section 4.4). 
 
In HIV-infected patients with severe immune deficiency at the time of initiation of combination 
antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic 
infections may arise. The frequency of this is unknown (see section 4.4). 
 
4.9 Overdose 
 
Human experience of acute overdose with VIRACEPT is limited. There is no specific antidote for 
overdose with nelfinavir. If indicated, elimination of unabsorbed nelfinavir should be achieved by 
emesis or gastric lavage. Administration of activated charcoal may also be used to aid removal of 
unabsorbed nelfinavir. Since nelfinavir is highly protein bound, dialysis is unlikely to significantly 
remove it from blood. 
 
Overdoses of nelfinavir could theoretically be associated with prolongation of the QT-interval of the 
ECG (see also section 5.3). Monitoring of overdosed patients is warranted.  
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: direct acting antivirals, ATC code: J05AE04  
 
Mechanism of action: HIV protease is an enzyme required for the proteolytic cleavage of the viral 
polyprotein precursors to the individual proteins found in infectious HIV. The cleavage of these viral 
polyproteins is essential for the maturation of infectious virus. Nelfinavir reversibly binds to the active 
site of HIV protease and prevents cleavage of the polyproteins resulting in the formation of immature 
non-infectious viral particles.  
 
Antiviral activity in vitro: the antiviral activity of nelfinavir in vitro has been demonstrated in both 
HIV acute and chronic infections in lymphoblastoid cell lines, peripheral blood lymphocytes and 
monocytes/macrophages. Nelfinavir was found to be active against a broad range of laboratory strains 
and clinical isolates of HIV-1 and the HIV-2 strain ROD. The EC95 (95 % effective concentration) of 
nelfinavir ranged from 7 to 111 nM (mean of 58 nM). Nelfinavir demonstrated additive to synergistic 
effects against HIV in combination with reverse transcriptase inhibitors zidovudine (ZDV), 
lamivudine (3TC), didanosine (ddI), zalcitabine (ddC) and stavudine (d4T) without enhanced 
cytotoxicity. 
 

 

 
 

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Resistance: Viral escape from nelfinavir can occur via viral protease mutations at amino acid positions 
30, 88 and 90. 
 
In vitro: HIV isolates with reduced susceptibility to nelfinavir have been selected in vitro. HIV isolates 
from selected patients treated with nelfinavir alone or in combination with reverse transcriptase 
inhibitors were monitored for phenotypic (n=19) and genotypic (n=195, 157 of which were assessable) 
changes in clinical trials over a period of 2 to 82 weeks. One or more viral protease mutations at amino 
acid positions 30, 35, 36, 46, 71, 77 and 88 were detected in > 10 % of patients with assessable 
isolates. Of 19 patients for whom both phenotypic and genotypic analyses were performed on clinical 
isolates, 9 patients isolates showed reduced susceptibility (5- to 93-fold) to nelfinavir in vitro. Isolates 
from all 9 patients possessed one or more mutations in the viral protease gene. Amino acid position 30 
appeared to be the most frequent mutation site. 
 
Cross resistance in vitro: HIV isolates obtained from 5 patients during nelfinavir therapy showed a 
5- to 93-fold decrease in nelfinavir susceptibility in vitro when compared to matched baseline isolates 
but did not demonstrate a concordant decrease in susceptibility to indinavir, ritonavir, saquinavir or 
amprenavir in vitro. Conversely, following ritonavir therapy, 6 of 7 clinical isolates with decreased 
ritonavir susceptibility (8- to 113-fold) in vitro compared to baseline also exhibited decreased 
susceptibility to nelfinavir in vitro (5- to 40 fold). An HIV isolate obtained from a patient receiving 
saquinavir therapy showed decreased susceptibility to saquinavir (7- fold) but did not demonstrate a 
concordant decrease in susceptibility to nelfinavir. Cross-resistance between nelfinavir and reverse 
transcriptase inhibitors is unlikely because different enzyme targets are involved. Clinical isolates 
(n=5) with decreased susceptibility to zidovudine, lamivudine, or nevirapine remain fully susceptible 
to nelfinavir in vitro. 
 
In vivo: The overall incidence of the D30N mutation in the viral protease of assessable isolates 
(n=157) from patients receiving nelfinavir monotherapy or nelfinavir in combination with zidovudine 
and lamivudine or stavudine was 54.8 %. The overall incidence of other mutations associated with 
primary PI resistance was 9.6 % for the L90M substitution where as substitutions at 48, 82 and 84 
were not observed. 
 
Clinical pharmacodynamic data: treatment with nelfinavir alone or in combination with other 
antiretroviral agents has been documented to reduce viral load and increase CD4 cell counts in HIV-1 
seropositive patients. Decreases in HIV RNA observed with nelfinavir monotherapy were less 
pronounced and of shorter duration. The effects of nelfinavir (alone or combined with other 
antiretroviral agents) on biological markers of disease activity, CD4 cell count and viral RNA, were 
evaluated in several studies involving HIV-1 infected patients. 
 
The efficacy of the BID regimen has been evaluated versus the TID regimen with VIRACEPT 250 mg 
tablets primarily in patients naïve to PIs. A randomised open-label study compared the HIV RNA 
suppression of nelfinavir 1250 mg BID versus nelfinavir 750 mg TID in PI naïve patients also 
receiving stavudine (30-40 mg BID) and lamivudine (150 mg BID). 
 
Proportion of patients with HIV RNA below LOQ (sensitive and ultrasensitive assays) at Week 48 
Assay Analysis Viracept BID (%) Viracept TID (%) 95 % CI 

Observed data 135/164 (82 %) 146/169 (86 %) (-12, +4) 
LOCF 145/200 (73 %) 161/206 (78 %) (-14, +3) 

 
Sensitive  

ITT (NC = F) 135/200 (68 %) 146/206 (71 %) (-12, +6) 
Observed data 114/164 (70 %) 125/169 (74 %) (-14, +5) 
LOCF 121/200 (61 %) 136/206 (66 %) (-15, +4) 

 
Ultrasensitive  

ITT (NC = F) 114/200 (57 %) 125/206 (61 %) (-13, +6) 
LOCF= Last observation carried forward 
ITT = Intention to Treat 
NC = F: non-completers = failures 
 
The BID regimen produced statistically significantly higher peak nelfinavir plasma levels versus the 
TID regimen. Small, non-statistically significant differences were observed in other pharmacokinetic 
parameters with no trend favouring one regimen over the other. Although study 542 showed no 

 

 
 

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statistically significant differences between the two regimens in efficacy in a predominantly 
antiretroviral naïve patient population, the significance of these findings for antiretroviral experienced 
patients is unknown. 
 
In a study of 297 HIV-1 seropositive patients receiving zidovudine and lamivudine plus nelfinavir 
(2 different doses) or zidovudine and lamivudine alone, the mean baseline CD4 cell count was 
288 cells/mm3 and the mean baseline plasma HIV RNA was 5.21 log10 copies/ml (160,394 copies/ml). 
The mean decrease in plasma HIV RNA using a PCR assay (< 400 copies/ml) at 24 weeks was 
2.33 log10 in patients receiving combination therapy with nelfinavir 750 mg TID, compared to 
1.34 log10 in patients receiving zidovudine and lamivudine alone. At 24 weeks, the percentage of 
patients whose plasma HIV RNA levels had decreased to below the limit of detection of the assay 
(< 400 copies/ml) were 81 % and 8 % for the groups treated with nelfinavir 750 mg TID plus 
zidovudine and lamivudine or zidovudine and lamivudine, respectively. Mean CD4 cell counts at 
24 weeks were increased by 150 and 95 cells/mm3 for the groups treated with nelfinavir 750 mg TID 
plus zidovudine and lamivudine or zidovudine and lamivudine, respectively. At 48 weeks, 
approximately 75 % of the patients treated with nelfinavir 750 mg TID plus zidovudine and 
lamivudine remained below the level of detection of the assay (< 400 copies/ml); mean increase in 
CD4 cell counts was 198 cells/mm3 at 48 weeks in this group. 
 
No important differences in safety or tolerability were observed between the BID and TID dosing 
groups, with the same proportion of patients in each arm experiencing adverse events of any intensity, 
irrespective of relationship to trial medication.  
 
Plasma levels of certain HIV-1 protease inhibitors, which are metabolised predominantly by CYP3A4, 
can be increased by the co-administration of low-dose ritonavir, which is an inhibitor of this 
metabolism. Treatment paradigms for several protease inhibitors, which are subject to this interaction, 
require the co-administration of low-dose ritonavir (‘boosting’) in order to enhance plasma levels and 
optimise antiviral efficacy. Plasma levels of nelfinavir, which is metabolised predominantly by 
CYP2C19 and only partially by CYP3A4, are not greatly increased by co-administration with 
ritonavir, and therefore nelfinavir does not require co-administration with low-dose ritonavir . Two 
studies have compared the safety and efficacy of nelfinavir (unboosted) with ritonavir- boosted 
protease inhibitors, each in combination with other antiretroviral agents. 
 
Study M98-863 is a randomised, double blind trial of 653 antiretroviral-naïve patients investigating 
lopinavir/ritonavir (400/100 mg BID n=326) compared to nelfinavir (750 mg TID n=327), each in 
combination with lamivudine (150 mg twice daily) and stavudine (40 mg twice daily). Median 
baseline HIV-1 RNA was 4.98 log10 copies/ml and 5.01 log10 copies/ml in the nelfinavir and 
lopinavir/ritonavir treatment groups respectively. Median baseline CD4+ cell count was 232 cells/mm3 
in both groups. At week 48, 63 % nelfinavir and 75 % lopinavir/ritonavir patients had HIV-1 RNA < 
400 copies/ml, whereas 52 % nelfinavir and 67 % lopinavir/ritonavir patients had HIV-1 RNA <50 
copies/ml (intent-to-treat, missing = failure). The mean increase from baseline in CD4+ cell count at 
week 48 was 195 cells/mm3 and 207 cells/mm3 in the nelfinavir and lopinavir/ritonavir groups 
respectively. Through 48 weeks of therapy, a statistically significantly higher proportion of patients in 
the lopinavir/ritonavir arm had HIV-1 RNA < 50 copies/ml compared to the nelfinavir arm.  
 
Study APV30002 is a randomised, open-label trial of 649 antiretroviral treatment naïve patients with 
advanced HIV-disease, investigating fosamprenavir/ritonavir (1400 mg/200 mg QD n=322) compared 
to nelfinavir (1250 mg BID n=327), each in combination with lamivudine (150 mg twice daily) and 
abacavir (300 mg twice daily). Median baseline HIV-1 RNA was 4.8 log10 copies/ml in both treatment 
groups. Median baseline CD4+ cell counts were 177 and 166 x106 cells/l for the nelfinavir and 
fosamprenavir/ritonavir groups respectively. At week 48, non-inferiority was shown with 68 % of 
patients in the group treated with nelfinavir and 69 % patients treated with fosamprenavir/ritonavir 
having plasma HIV-1 RNA <400 copies/ml whereas 53 % in the nelfinavir and 55 % in the 
fosamprenavir/ritonavir patients had HIV-1 RNA <50 copies/ml (intent-to-treat, 
rebound/discontinuation = failure). The median increase from baseline in CD4+ cell count over 48 
weeks was 207 cells/mm3 and 203 cells/mm3 in the nelfinavir and fosamprenavir/ritonavir groups 
respectively. The virological failure was greater in the nelfinavir group (17 %) than in the 

 

 
 

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fosamprenavir/ritonavir group (7 %). Treatment emergent NRTI resistance was significantly less 
frequent with fosamprenavir/ritonavir compared to nelfinavir (13 % versus 57 %; p<0.001). 
 
5.2 Pharmacokinetic properties 
 
The pharmacokinetic properties of nelfinavir have been evaluated in healthy volunteers and 
HIV-infected patients. No substantial differences have been observed between healthy volunteers and 
HIV-infected patients. 
 
Absorption: after single or multiple oral doses of 500 to 750 mg (two to three 250 mg tablets) with 
food, peak nelfinavir plasma concentrations were typically achieved in 2 to 4 hours. 
 
After multiple dosing with 750 mg every 8 hours for 28 days (steady-state), peak plasma 
concentrations (Cmax) averaged 3-4 µg/ml and plasma concentrations prior to the next dose (trough) 
were 1-3 µg/ml. A greater than dose-proportional increase in nelfinavir plasma concentrations was 
observed after single doses; however, this was not observed after multiple dosing. 
 
A pharmacokinetic study in HIV-positive patients compared multiple doses of 1250 mg twice daily 
(BID) with multiple doses of 750 mg three times daily (TID) for 28 days. Patients receiving 
VIRACEPT BID (n=10) achieved nelfinavir Cmax of 4.0 ± 0.8 µg/ml and morning and evening trough 
concentrations of 2.2 ± 1.3 µg/ml and 0.7 ± 0.4 µg/ml, respectively. Patients receiving VIRACEPT 
TID (n=11) achieved nelfinavir peak plasma concentrations (Cmax) of 3.0 ± 1.6 µg/ml and morning and 
evening trough concentrations of 1.4 ± 0.6 µg/ml and 1.0 ± 0.5 µg/ml, respectively. The difference 
between morning and afternoon or evening trough concentrations for the TID and BID regimens was 
also observed in healthy volunteers who were dosed at precise 8- or 12-hour intervals. 
 
The pharmacokinetics of nelfinavir are similar during BID and TID administration. In patients, the 
nelfinavir AUC0-24 with 1250 mg BID administration was 52.8 ± 15.7 µg⋅h/ml (n=10) and with 750 mg 
TID administration was 43.6 ± 17.8 µg⋅h/ml (n=11). Trough drug exposures remain at least twenty 
fold greater than the mean IC95 throughout the dosing interval for both regimens. The clinical 
relevance of relating in vitro measures to drug potency and clinical outcome has not been established. 
A greater than dose-proportional increase in nelfinavir plasma concentrations was observed after 
single doses; however, this was not observed after multiple dosing. 
 
The absolute bioavailability of VIRACEPT has not been determined. 
 
Effect of Food on Oral Absorption 
Food increases nelfinavir exposure and decreases nelfinavir pharmacokinetic variability relative to the 
fasted state. In one study, healthy volunteers received a single dose of 1250 mg of VIRACEPT (5x 
250 mg tablets) under fasted or fed conditions (three meals with different caloric and fat contents). In a 
second study, healthy volunteers received single doses of 1250 mg VIRACEPT (5 x 250 mg tablets) 
under fasted or fed conditions (two meals with different fat content). The results from the two studies 
are summarized below. 
 
Increase in AUC, Cmax and Tmax for Nelfinavir in Fed State Relative to Fasted State Following 
1250 mg VIRACEPT (5 x 250 mg tablets) 
Number of 
Kcal 

% Fat Number of 
subjects 

AUC fold 
increase 

Cmax fold increase Increase in Tmax (hr) 

125 20 n=21 2.2 2.0 1.00 
500 20 n=22 3.1 2.3 2.00 
1000 50 n=23 5.2 3.3 2.00 
 

 

 
 

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Increase in Nelfinavir AUC, Cmax and Tmax in Fed Low Fat (20%) versus High fat (50%) State 
Relative to Fasted State Following 1250 mg VIRACEPT (5 x 250 mg tablets) 
Number of 
Kcal 

% Fat Number of 
Subjects 

AUC fold 
increase 

Cmax fold increase Increase in Tmax (hr) 

500 20 n=22 3.1 2.5 1.8 
500 50 n=22 5.1 3.8 2.1 
 
Nelfinavir exposure increases with increasing calorie or fat content of meals taken with VIRACEPT. 
 
Distribution: Nelfinavir in serum is extensively protein-bound (≥ 98 %). The estimated volumes of 
distribution in both animals and humans is 2-7 l/kg which exceeded total body water and suggests 
extensive penetration of nelfinavir into tissues. 
 
Metabolism: In vitro studies demonstrated that multiple cytochrome P-450 isoforms including 
CYP3A, CYP2C19/C9 and CYP2D6 are responsible for the metabolism of nelfinavir. One major and 
several minor oxidative metabolites were found in plasma. The major oxidative metabolite, M8 (tert-
butyl hydroxy nelfinavir), has in vitro antiviral activity equal to the parent drug and its formation is 
catalysed by the polymorphic cytochrome CYP2C19. The further degradation of M8 appears to be 
catalysed by CYP3A4. In subjects with normal CYP2C19 activity, plasma levels of this metabolite are 
approximately 25 % of the total plasma nelfinavir-related concentration. It is expected that in 
CYP2C19 poor metabolisers or in patients receiving concomitantly strong CYP2C19 inhibitors (see 
section 4.5), nelfinavir plasma levels would be elevated whereas levels of tert-butyl hydroxy nelfinavir 
would be negligible or non-measurable. 
 
Elimination: oral clearance estimates after single doses (24-33 l/h) and multiple doses (26-61 l/h) 
indicate that nelfinavir exhibits medium to high hepatic bioavailability. The terminal half-life in 
plasma was typically 3.5 to 5 hours. The majority (87 %) of an oral 750 mg dose containing 
14C-nelfinavir was recovered in the faeces; total faecal radioactivity consisted of nelfinavir (22 %) and 
numerous oxidative metabolites (78 %). Only 1-2 % of the dose was recovered in urine, of which 
unchanged nelfinavir was the major component. 
 
Pharmacokinetics in specialpopulations: 
 
Children: 
In children between the ages of 2 and 13 years, the clearance of orally administered nelfinavir is 
approximately 2 to 3 times higher than in adults, with large intersubject variability. Administration of 
VIRACEPT oral powder or tablets at a dose of approximately 25-30 mg/kg TID with food achieves 
steady-state plasma concentrations that are similar to those achieved in adult patients receiving 750 mg 
TID.  
 
The pharmacokinetics of nelfinavir have been investigated in 5 studies in paediatric patients from birth 
to 13 years of age. Patients received VIRACEPT either three times daily or twice daily with food or 
with meals. The dosing regimens and associated AUC24 values are summarized below. 
 

 

 
 

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Summary of Steady-state AUC24 of nelfinavir in Paediatric Studies 
 

Protocol No.  Dosing Regimen1  N2  Age  

 
Food taken  

with Viracept 

AUC24 
(mg.hr/L)  

Arithmetic mean 
± SD  

AG1343-524  20 (19-28) mg/kg TID 14  2-13 years  

 
Powder with milk, 

formula, pudding, or 
water, as part  

of a light meal or tablet  
taken with a light meal 

56.1 ± 29.8  

      

PACTG-725  6  3-11 years  With food 101.8 ± 56.1  
 

55 (48-60) mg/kg  
BID      

PENTA 7  4  2-9 months  With milk 33.8 ± 8.9  
 

40 (34-43) mg/kg  
TID      

PENTA 7  12  2-9 months  With milk 37.2 ± 19.2  
 

75 (55-83) mg/kg  
BID      

PACTG-353   40 (14-56) mg/kg BID  10  6 weeks  
Powder with water, 
milk, formula, soy 

formula, soy milk, or 
dietary supplements 

44.1 ± 27.4  

   1 week  45.8 ± 32.1 
1 Protocol specified dose (actual dose range) 
2  N: number of subjects with evaluable pharmacokinetic results 
Ctrough values are not presented in the table because they are not available from all studies 
 
Pharmacokinetic data are also available for 86 patients (age 2 to 12 years) who received VIRACEPT 
25-35 mg/kg TID in Study AG1343-556. The pharmacokinetic data from Study AG1343-556 were 
more variable than data from other studies conducted in the paediatric population; the 95% confidence 
interval for AUC24 was 9 to 121 mg.hr/L. 
 
Overall, use of VIRACEPT in the paediatric population is associated with highly variable drug 
exposure. The reason for this high variability is not known but may be due to inconsistent food intake 
in paediatric patients. 
 
Elderly: 
There are no data available in the elderly. 
 
Hepatic impairment: 
The multi-dose pharmacokinetics of nelfinavir have not been studied in HIV-positive patients with 
hepatic insufficiency. 
Pharmacokinetics of nelfinavir after a single dose of 750 mg was studied in patients with liver 
impairment and healthy volunteers. A 49 %-69 % increase was observed in AUC of nelfinavir in the 
hepatically impaired group (Child-Turcotte Classes A to C) compared to the healthy group. Specific 
dose recommendations for nelfinavir cannot be made based on the results of this study. 
A second study evaluated the steady state pharmacokinetics of nelfinavir (1250 mg twice daily for 2 
weeks) in adult HIV-seronegative subjects with mild (Child-Pugh A; n=6) or moderate (Child-Pugh B; 
n=6) hepatic impairment. Compared to control subjects with normal hepatic function, the AUC and 
Cmax of nelfinavir were not significantly different in subjects with mild impairment but were increased 
by 62% and 22%, respectively in subjects with moderate hepatic impairment. 
 

 

 
 

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5.3 Preclinical safety data 
 
During in vitro studies, cloned human cardiac potassium channels (hERG) were inhibited by high 
concentrations of nelfinavir and its active metabolite M8. hERG potassium channels were inhibited by 
20 % at nelfinavir and M8 concentrations that are about four- to five-fold and seventy-fold, 
respectively, above the average free therapeutic levels in humans. By contrast, no effects suggesting 
prolongation of the QT-interval of the ECG were observed at similar doses in dogs or in isolated 
cardiac tissue. The clinical relevance of these in vitro data is unknown. However, based on data from 
products known to prolong the QT-interval, a block of hERG potassium channels of > 20 % may be 
clinically relevant. Therefore the potential for QT prolongation should be considered in cases of 
overdose (see section 4.9). 
 
Acute and chronic toxicity: oral acute and chronic toxicity studies were conducted in the mouse 
(500 mg/kg/day), rat (up to 1,000 mg/kg/day) and monkey (up to 800 mg/kg/day). There were 
increased liver weights and dose-related thyroid follicular cell hypertrophy in rats. Weight loss and 
general physical decline was observed in monkeys together with general evidence of gastrointestinal 
toxicity.  
 
Mutagenicity: in vitro and in vivo studies with and without metabolic activation have shown that 
nelfinavir has no mutagenic or genotoxic activity. 
 
Carcinogenicity: Two year oral carcinogenicity studies with nelfinavir mesilate were conducted in 
mice and rats. In mice, administration of up to 1000 mg/kg/day did not result in any evidence for an 
oncogenic effect. In rats administration of 1000 mg/kg/day resulted in increased incidences of thyroid 
follicular cell adenoma and carcinoma, relative to those for controls. Systemic exposures were 3 to 4 
times those for humans given therapeutic doses. Administration of 300 mg/kg/day resulted in an 
increased incidence of thyroid follicular cell adenoma. Chronic nelfinavir treatment of rats has been 
demonstrated to produce effects consistent with enzyme induction, which predisposed rats, but not 
humans, to thyroid neoplasms. The weight of evidence indicates that nelfinavir is unlikely to be a 
carcinogen in humans. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Each tablet contains the following excipients: 
 
Tablet core: 
Calcium silicate,  
Crospovidone,  
Magnesium stearate,  
Indigo carmine (E132) as powder. 
 
Tablet coat: 
Hypromellose, 
Glycerol triacetate. 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
3 years. 
 

 

 
 

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6.4 Special precautions for storage 
 
Store in the original container. Do not store above 30°C. 
 
6.5 Nature and contents of container 
 
VIRACEPT film-coated tablets are provided in HDPE plastic bottles containing either 270 or 300 
tablets, fitted with HDPE child resistant closures with polyethylene liners. Not all pack sizes may be 
marketed. 
 
6.6 Special precautions for disposal and other handling 
 
No special requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Roche Registration Limited 
6 Falcon Way 
Shire Park 
Welwyn Garden City 
AL7 1TW 
United Kingdom 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/97/054/004 - EU/1/97/054/005 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 22 January 1998 
Date of latest renewal: 23 January 2008 
 
 
10. DATE OF REVISION OF THE TEXT 

 

 
 

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ANNEX II 
 

A. MANUFACTURING AUTHORISATION HOLDER(S) 
RESPONSIBLE FOR BATCH RELEASE 

 
B. CONDITIONS OF THE MARKETING AUTHORISATION 

 

 

 
 

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A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH 
RELEASE 

 
Name and address of the manufacturer responsible for batch release 
 
VIRACEPT 50 mg/g oral powder 
 
Roche Pharma AG 
Emil-Barell-Strasse 1 
D-79639 Grenzach-Wyhlen 
Germany 
 
VIRACEPT 250 mg film-coated tablets: 
 
Roche Pharma AG 
Emil-Barell-Strasse 1 
D-79639 Grenzach-Whylen 
Germany 
 
The printed package leaflet of the medicinal product must state the name and address of the 
manufacturer responsible for the release of the concerned batch. 
 
 
B. CONDITIONS OF THE MARKETING AUTHORISATION 
 
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON 

THE MARKETING AUTHORISATION HOLDER 
 
Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product 
Characteristics, 4.2.) 
 
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 
Not applicable. 
 
• OTHER CONDITIONS 
 
Risk Management Plan 
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in 
the Pharmacovigilance Plan, as agreed in version 1, dated 30 July 2007 of the Risk Management Plan 
(RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent 
updates of the RMP agreed by the CHMP. 
 
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the 
updated RMP should be submitted at the same time as the next Periodic Safety Update Report 
(PSUR). 
 
In addition, an updated RMP should be submitted 
• When new information is received that may impact on the current Safety Specification, 

Pharmacovigilance Plan or risk minimisation activities 
• Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being 

reached 
• At the request of the European Medicines Agency 
 
PSUR: The Marketing Authorisation Holder will submit yearly PSURs. 
 

 

 
 

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ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 

 

 
 

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A. LABELLING 

 

 
 

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PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE 
PACKAGING 
 
OUTER CARTON TEXT 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Viracept 50 mg/g oral powder 
Nelfinavir 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
The bottle contains 144 g of oral powder. Each gram of oral powder contains nelfinavir mesilate 
corresponding to 50 mg of nelfinavir. 
 
 
3. LIST OF EXCIPIENTS 
 
Also contains sweetener aspartame (E951), sucrose palmitate, potassium, natural and artificial 
flavourings and other constituents. See the Package Leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
144 g Oral powder 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use 
Read the package leaflet before use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE REACH AND SIGHT OF CHILDREN 
 
Keep out of the reach and sight of children 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
Do not reconstitute in the bottle 
 
 
8. EXPIRY DATE 
 
EXP  
 
 

 

 
 

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9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 30°C 
Store in the original container 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Roche Registration Limited 
6 Falcon Way 
Shire Park 
Welwyn Garden City 
AL7 1TW 
United Kingdom 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/97/054/001 
 
 
13. BATCH NUMBER 
 
Batch  
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
viracept 50 mg  
 
 

 

 
 

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PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE 
PACKAGING 
 
BOTTLE LABEL TEXT 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Viracept 50 mg/g oral powder 
Nelfinavir 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each gram of oral powder contains 50 mg of nelfinavir (as mesilate). 
 
 
3. LIST OF EXCIPIENTS 
 
Also contains E95, sucrose palmitate, potassium. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
144 g  
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use 
Read the package leaflet before use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE REACH AND SIGHT OF CHILDREN 
 
Keep out of the reach and sight of children 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
Do not reconstitute in the bottle 
 
 
8. EXPIRY DATE 
 
EXP  
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 30°C 
Store in the original container 
 
 

 

 
 

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10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
‘Logo’ 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/97/054/001 
 
 
13. BATCH NUMBER 
 
Batch  
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
 
 
 
 

 

 
 

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PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE 
PACKAGING 
 
OUTER CARTON TEXT  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Viracept 250 mg film-coated tablets 
Nelfinavir 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each film-coated tablet contains 292.25 mg of nelfinavir mesilate, equivalent to 250 mg nelfinavir as 
free base. 
 
 
3. LIST OF EXCIPIENTS 
 
Also contains colourant indigocarmine (E132) and other constituents.  
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
270 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use 
Read the package leaflet before use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE REACH AND SIGHT OF CHILDREN 
 
Keep out of the reach and sight of children 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP  
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 30°C 
 
Store in the original container 
 
 

 

 
 

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10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Roche Registration Limited 
6 Falcon Way 
Shire Park 
Welwyn Garden City 
AL7 1TW 
United Kingdom 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/01/097/054/004 
 
 
13. BATCH NUMBER 
 
Batch  
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
viracept 250 mg 
 
 

 

 
 

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PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE 
PACKAGING 
 
BOTTLE LABEL TEXT 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Viracept 250 mg film-coated tablets 
Nelfinavir 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each film-coated tablet contains 250 mg of nelfinavir (as mesilate). 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
270 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use 
Read the package leaflet before use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE REACH AND SIGHT OF CHILDREN 
 
Keep out of the reach and sight of children 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP  
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 30°C 
 
Store in the original container 
 
 

 

 
 

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10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
‘Logo’ 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/01/097/054/004 
 
 
13. BATCH NUMBER 
 
Batch  
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
 

 

 
 

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PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE 
PACKAGING 
 
OUTER CARTON TEXT  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Viracept 250 mg film-coated tablets 
Nelfinavir 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each film-coated tablet contains 292.25 mg of nelfinavir mesilate, equivalent to 250 mg nelfinavir as 
free base. 
 
 
3. LIST OF EXCIPIENTS 
 
Also contains colourant indigocarmine (E132) and other constituents. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
300 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use 
Read the package leaflet before use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE REACH AND SIGHT OF CHILDREN 
 
Keep out of the reach and sight of children 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 30°C 
 
Store in the original container 
 
 

 

 
 

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10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Roche Registration Limited 
6 Falcon Way 
Shire Park 
Welwyn Garden City 
AL7 1TW 
United Kingdom 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/97/054/005 
 
 
13. MANUFACTURER’S BATCH NUMBER 
 
Batch  
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
viracept 250 mg 
 
 

 

 
 

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PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE 
PACKAGING 
 
BOTTLE LABEL TEXT 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Viracept 250 mg film-coated tablets 
Nelfinavir 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each film-coated tablet contains 250 mg of nelfinavir (as mesilate). 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
300 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use 
Read the package leaflet before use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE REACH AND SIGHT OF CHILDREN 
 
Keep out of the reach and sight of children 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 30°C 
 
Store in the original container 
 
 

 

 
 

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10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
‘Logo’ 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/97/054/005 
 
 
13. MANUFACTURER’S BATCH NUMBER 
 
Batch  
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
 

 

 
 

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B. PACKAGE LEAFLET 

 

 
 

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PACKAGE LEAFLET: INFORMATION FOR THE USER 
 

VIRACEPT 50 mg/g oral powder 
Nelfinavir 

 
Read all of this leaflet carefully before you start taking this medicine. 
• Keep this leaflet. You may need to read it again. 
• If you have any further questions, ask your doctor or pharmacist. 
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even 

if their symptoms are the same as yours. 
• If any of the side effects become serious or troublesome, or if you notice any side effects not 

listed in this leaflet, please tell your doctor or pharmacist. 
 
 
In this leaflet: 
1. What Viracept is and what it is used for 
2. Before you take Viracept 
3. How to take Viracept 
4. Possible side effects 
5. How to store Viracept 
6. Further information 
 
 
 
1. WHAT VIRACEPT IS AND WHAT IT IS USED FOR 
 
What Viracept is 
Viracept contains a medicine called nelfinavir, which is a ‘protease inhibitor’.  This belongs to a group 
of medicines called ‘anti-retrovirals’.  
 
What Viracept is used for 
Viracept is used with other ‘anti-retroviral’ medicines to: 
• Work against the Human Immunodeficiency Virus (HIV). It helps to reduce the number of HIV 

particles in your blood. 
• Increase the number of some cells in your blood that help fight infection. These are called CD4 

white blood cells. They are particularly reduced in numbers when you have HIV infection. This 
can lead to an increased risk of many types of infections. 

 
Viracept is not a cure for HIV infection. You may continue to get infections or other illnesses due to 
your HIV. Treatment with Viracept does not stop you giving HIV to others through contact with blood 
or sexual contact. Therefore you must keep taking appropriate precautions to avoid giving the virus to 
others when you are taking Viracept. 
 
 
2. BEFORE YOU TAKE VIRACEPT 
 
Do not take Viracept if: 
• You are allergic to nelfinavir or to any of the other ingredients (listed in Section 6 ‘Further 

information’). 
• You are taking any of the medicines listed in the first part of Section 2 ‘Taking other 

medicines’, ‘Do not take Viracept’. 
Do not take Viracept if any of the above apply to you.  
 

 

 
 

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Take special care with Viracept 
Check with your doctor or pharmacist before taking Viracept if: 
• You have kidney problems. 
• You have high blood sugar (diabetes). 
• You have a rare blood problem which runs in families called ‘haemophilia’. 
• You have liver disease caused by hepatitis B or C. Your doctor may wish to carry out regular 

blood tests.  
If any of the above apply to you, or if you are not sure, talk to your doctor or pharmacist before you 
take Viracept. 
 
Patients with liver disease 
Patients with chronic hepatitis B or C and treated with anti-retroviral agents are at increased risk for 
severe and potentially fatal liver adverse events and may require blood tests for control of liver 
function. Speak with your doctor if you have a history of liver disease. 
 
Body fat 
Combination anti-retroviral therapy may cause changes in body shape due to changes in fat 
distribution. These may include loss of fat from legs, arms and face, increased fat in the abdomen 
(belly) and other internal organs, breast enlargement and fatty lumps on the back of the neck (‘buffalo 
hump’). The cause and long-term health effects of these conditions are not known at this time. Contact 
your doctor if you notice changes in body fat. 
 
Signs of previous infections 
In some patients with advanced HIV infection and a history of opportunistic infection, signs and 
symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is 
started. It is believed that these symptoms are due to an improvement in the body’s immune response, 
enabling the body to fight infections that may have been present with no obvious symptoms. If you 
notice any symptoms of infection, please inform your doctor immediately.  
 
Bone disease (osteonecrosis) 
Some patients taking combination anti-retroviral therapy may develop a bone disease called 
osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). The length of 
combination anti-retroviral therapy, corticosteroid use, alcohol consumption, severe 
immunosuppression, higher body mass index, among others, may be some of the many risk factors for 
developing this disease. Signs of osteonecrosis are joint stiffness, aches and pains (especially of the 
hip, knee and shoulder) and difficulty in movement. If you notice any of these symptoms please 
inform your doctor immediately. 
 
Taking other medicines 
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This 
includes medicines that you buy without a prescription and herbal medicines. This is because Viracept 
can affect the way some other medicines work. Also some other medicines can affect the way Viracept 
works. 
 
Do not take Viracept and tell your doctor or pharmacist if you are taking any of the following 
medicines: 
• Medicines made from ergot such as cabergoline, ergotamine or lisuride (for Parkinson’s disease 

or migraine) 
• Herbal preparations containing St. John’s Wort (for depression or improving your mood)  
• Rifampicin (for tuberculosis (TB)) 
• Terfenadine or astemizole (for allergy) 
• Pimozide (used for mental health problems) 
• Amiodarone or quinidine (for an uneven heart beat) 
• Phenobarbital or carbamazepine (for fits or epilepsy) 
• Triazolam or oral midazolam taken by mouth (for anxiety or to help you sleep) 
• Cisapride (for heart burn or problems with your digestive system) 

 

 
 

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• Omeprazole (for ulcers in your stomach or gut) 
• Alfuzosin (for benign prostatic hyperplasia (BPH)) 
• Sildenafil (for pulmonary arterial hypertension (PAH)) 
• Simvastatin or lovastatin (for lowering blood cholesterol) 
 
Do not take Viracept and tell your doctor or pharmacist if any of these apply to you. If you are not 
sure, talk to your doctor or pharmacist before taking Viracept. 
 
Tell your doctor or pharmacist if you are taking any of the following medicines: 
• Any other medicines for HIV infection such as ritonavir, indinavir, saquinavir and delavirdine, 

amprenavir, efavirenz or nevirapine 
• Oral contraceptives (the pill). Viracept can stop the pill from working, so you should use other 

contraception methods (such as condoms) while you are taking Viracept. 
• Calcium channel blockers such as bepridil (for heart problems)  
• Immunosuppressant medicines such as tacrolimus or ciclosporin 
• Medicines that lower stomach acid such as lansoprazole 
• Fluticasone (for hay fever) 
• Phenytoin (for fits or epilepsy) 
• Methadone (for drug dependence) 
• Sildenafil (for getting or keeping an erection) 
• Tadalafil (for pulmonary arterial hypertension (PAH), or for getting or keeping an erection) 
• Vardenafil (for pulmonary arterial hypertension (PAH), or for getting or keeping an erection) 
• Ketoconazole, itraconazole or fluconazole (for fungal infections) 
• Rifabutin, erythromycin or clarithromycin (for bacterial infections) 
• Midazolam given by injection or diazepam (for anxiety or to help you sleep) 
• Fluoxetine, paroxetine, imipramine, amitriptyline or trazodone (for depression) 
• Atorvastatinor other statins(for lowering blood cholesterol) 

• Salmeterol (for asthma or chronic obstructive pulmonary disease (COPD)) 
• Warfarin (for lowering the chance of blood clots in your body) 
• Colchicine (for gout-flares or Mediterranean fever) 
• Bosentan (for pulmonary arterial hypertension (PAH) 
) 
If any of the above apply to you, or if you are not sure, talk to your doctor or pharmacist before you 
take Viracept.  
 
Taking Viracept with food and drink 
Take Viracept with a meal. This helps your body to get the full benefit from your medicine. 
 
Pregnancy, contraception and breast-feeding 
• Talk to your doctor before you take Viracept if you are pregnant or planning to become 

pregnant. 
• Do not breast-feed while taking Viracept because HIV may be passed to the baby. 
• Viracept can stop oral contraceptives (the pill) from working, so you should use other  

contraception methods (such as condoms) while you are taking Viracept. 
• Ask your doctor or pharmacist for advice before taking any medicine.  
 
Driving and using machines 
Viracept is not likely to affect you being able to drive or use any tools or machines. 
 
Important information about some of the ingredients of Viracept 
• This medicine contains sucrose, which is a type of sugar. If you have been told by your doctor 

that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your 
doctor before taking this medicine. Each dose contains up to 5.9 milligrams of sucrose, which 
should be taken into account in patients with diabetes mellitus. 

 

 
 

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• This medicine contains aspartame, which is a source of phenylalanine. This may be harmful for 
people with phenylketonuria. 

• This medicine is essentially ‘potassium-free’ as it contains less than 1 mmol (39 milligrams) of 
potassium per dose. 

 
If any of the above apply to you, or if you are not sure, talk to your doctor or pharmacist before you 
take Viracept. 
 
 
3. HOW TO TAKE VIRACEPT 
 
Always take Viracept exactly as your doctor has told you. You should check with your doctor or 
pharmacist if you are unsure. The usual doses are described below. Follow the instructions carefully to 
get the most benefit from Viracept. 
 
Viracept powder is for people who cannot take tablets. Viracept tablets are generally recommended for 
adults and older children. For younger children able to take tablets, Viracept tablets may be taken 
instead of the oral powder. If you want to take the tablets instead please see the Package Leaflet for 
Viracept 250 mg tablets. 
 
How to prepare Viracept 
Two measuring scoops are provided in the medicine box: 
• White 1 gram (1g) scoop. 
• Blue 5 gram (5g) scoop. 
 
Measure out a level scoop of powder. You can use the handle of the second scoop to scrape off the 
extra powder and make your scoop level (see picture below). 
 

 

 
 
• You can mix the powder with a small amount of water, milk, baby formula, soy formula, soy 

milk, dietary liquid supplements or pudding.  
• If you mix the powder, but do not take it straight away you can store it for up to 6 hours in a 

refrigerator. 
• Do not mix the powder with orange juice, apple sauce or other acidic liquids or foods. This may 

give your medicine a bitter taste. 
• Do not add liquid to the powder in its original container 
 
Taking this medicine 
• Take Viracept with a meal. This helps your body to get the full benefit from your 

medicine. 
• Take all the mixture you make each time. This will make sure that you get the right amount of 

your medicine. 
• Take all your doses at the right time each day. This helps make your medicine work as well as it 

can. 
• Do not stop taking this medicine without talking to your doctor first. 
 

 

 
 

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How much to take 
 
 Adults and children older than 13 years 

Viracept powder can be taken either two or three times  a day with a meal.  Table 1 below 
shows the usual doses. 

Table 1 
Dose to be taken by adults and children older than 13 years 
 
How often 
you take it 
 

Number of scoops 
Blue Scoop           White Scoop 
   (5 g)                             (1 g) 
 

How much you take 
each time (in grams) 

Two times a 
day 

 

      5                                - 25 g 

Three times a 
day 

      3                                - 15 g 

 
 Children aged 3 to 13 years 

For children aged 3 to 13 years, the recommended dose of Viracept powder is based on their 
body weight. You will either give the medicine to your child two or three times a day with a 
meal.  
 
The different ways are shown in separate tables below.  
• Table 2: if you give the medicine two times a day, you will give 50-55 mg nelfinavir 

each time for each kg of body weight.  
• Table 3: if you give the medicine three times a day, you will give 25-35 mg nelfinavir 

each time for each kg of body weight. 
 

Table 2 
 
Dose to be given two times a day to children aged 3 to 13 
 
Body weight 
of your child 
 

Number of scoops 
Blue Scoop           White Scoop 
   (5 g)                          (1 g) 
 

How much to give 
each time            
(in grams) 

  7.5 to  8.5  kg       1               plus         3       8 g 
  8.5 to 10.5 kg       2                               -      10 g 
10.5 to 12    kg       2               plus         2      12 g 
12    to 14    kg       2               plus         4      14 g 
14    to 16    kg       3               plus         1      16 g 
16    to 18    kg       3               plus         3      18 g 
18    to 22    kg       4               plus         1      21 g 
  over   22   kg       5                               -      25 g 

 

 

 
 

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Table 3 
 
Dose to be given three times a day to children aged 3 to 13 
 
Body weight 
of your child 
 

Number of scoops 
Blue Scoop           White Scoop 
   (5 g)                              (1 g) 
 

How much to give 
each time            
(in grams) 

  7.5 to  8.5  kg       1                                       5 g 
  8.5 to 10.5 kg       1              plus           1       6 g 
10.5 to 12    kg       1              plus           2       7 g 
12    to 14    kg       1              plus           3       8 g 
14    to 16    kg       2                   10 g 
16    to 18    kg       2              plus           1     11 g 
18    to 22    kg       2              plus           3     13 g 
  over   22    kg       3                                     15 g 

 
If you take more Viracept than you should 
If you take more Viracept than you should, talk to a doctor or pharmacist or go to a hospital straight 
away. Take the medicine pack with you. Among other things, very large doses of Viracept might 
cause problems with your heart rhythm. 
 
If you forget to take Viracept 
If you forget to take a dose, take it as soon as you remember it.  
• However if it is nearly time for your next dose, skip the missed dose. 
• Do not take a double dose to make up for a forgotten dose. 
 
If you stop taking Viracept 
Do not stop taking this medicine without talking to your doctor first. Take all your doses at the right 
time each day. This helps make your medicine work as well as it can. 
 
 
4. POSSIBLE SIDE EFFECTS 
 
Like all medicines, Viracept can have side effects, although not everybody gets them. The following 
side effects may happen with this medicine. 
 
Contact your doctor straight away if you notice any of the following side effects: 
• Allergic reactions. The signs may include difficulty in breathing, fever, itching, swelling of the 

face and skin rashes that can sometimes form blisters. 
• Increased bleeding if you have haemophilia. If you have haemophilia type A or B, in rare 

cases your bleeding may increase.  
• Bone disease (osteonecrosis). The signs may include joint stiffness, aches and pains (especially 

of the hip, knee and shoulder) and difficulty in movement. Some patients taking combination 
anti-retroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue 
caused by loss of blood supply to the bone).  

• Infection. In some patients with advanced HIV infection and a history of opportunistic 
infection, signs and symptoms of inflammation from previous infections may occur soon after 
anti-HIV treatment is started. It is believed that these symptoms are due to an improvement in 
the body’s immune response, enabling the body to fight infections that may have been present 
with no obvious symptoms.  

 
If you notice any of the above, contact your doctor straight away. 
 

 

 
 

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65 

Other possible side effects, where you should talk to your doctor 
If you get any of the side effects on this list, or if you notice any side effects not listed in this leaflet, 
please tell your doctor. 
 
Very common (affect more than 1 in 10 people): 
• Diarrhoea. 
 
Common (affect less than 1 in 10 people): 
• Rash. 
• Wind. 
• Feeling sick.  
• Low numbers of a type of white blood cell that fights infections (neutrophils). 
• Abnormal results from blood tests that measure how well your liver or muscles are working. 
 
Uncommon (affect less than 1 in 100 people): 
• Being sick. 
• Pancreatitis. The signs include severe pains in your stomach that spread to your back. 
• Combination anti-retroviral therapy may cause changes in body shape due to changes in fat 

distribution. These may include loss of fat from legs, arms and face, increased fat in the 
abdomen (belly) and other internal organs, breast enlargement and fatty lumps on the back of 
the neck (‘buffalo hump’). The cause and long-term health effects of these conditions are not 
known at this time.  

 
Rare (affect less than 1 in 1000 people): 
• Yellow skin or eyes. This could be a sign of a liver problem such as hepatitis or jaundice. 
• A severe form of rash (erythema multiforme). 
• Swelling of your belly (abdomen). 
• High blood sugar (diabetes) or diabetes get worse. 
• There have been rare reports of muscle pain, tenderness or weakness, particularly with 

combination anti-retroviral therapy including protease inhibitors and nucleoside analogues. On 
rare occasions these muscle problems have been serious causing muscle degeneration 
(rhabdomyolysis). 

 
Other side effects which have also been reported: 
• Combination anti-retroviral therapy may also cause raised lactic acid and sugar in the blood, 

hyperlipaemia (increased fats in the blood) and resistance to insulin. 
• Low numbers of red blood cells (anaemia). 
• Lung disease (pneumonia). 
• Cases of diabetes mellitus or increased blood sugar levels have been reported in patients 

receiving this treatment or another protease inhibitor. 
 
Side effects in children 
About 400 children (aged from 0 to 13 years) received Viracept in clinical trials. The side effects seen 
in children are similar to those seen in adults. The most commonly reported side effect in children is 
diarrhoea. The side effects only rarely resulted into having to stop taking Viracept. 
 
 
5. HOW TO STORE VIRACEPT 
 
• Keep out of the reach and sight of children. 
• Do not use after the expiry date stated on the label and carton. 
• Do not store above 30°C. 
• Store in the original container. 
• The mixed solution can be stored for up to 6 hours in a refrigerator. 
 
 

 

 
 

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66 

6. FURTHER INFORMATION 
 
What Viracept contains 
• The active substance in Viracept is nelfinavir. Each gram of oral powder contains an amount of 

nelfinavir mesilate that makes 50 mg of nelfinavir. 
• The other ingredients are microcrystalline cellulose, maltodextrin, dibasic potassium phosphate, 

crospovidone, hydroxypropyl methylcellulose, aspartame (E951), sucrose palmitate, and natural 
and artificial flavour. 

 
What Viracept looks like and contents of the pack 
Viracept 50 mg/g oral powder is a white to off-white powder. It is supplied in plastic bottles with 
plastic child resistant lids. Each bottle contains 144 grams of powder and is supplied with a 1 gram 
scoop (white) and a 5 gram scoop (blue). 
 
 
Marketing Authorisation Holder and Manufacturer 
 
Roche Registration Limited 
6 Falcon Way 
Shire Park 
Welwyn Garden City 
AL7 1TW 
United Kingdom 
 
Manufacturer 
 
Roche Pharma AG 
Emil-Barell-Str. 1 
D-79639 Grenzach-Wyhlen 
Germany 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
N.V. Roche S.A. 
Tél/Tel: +32 (0) 2 525 82 11 
 

Luxembourg/Luxemburg 
(Voir/siehe Belgique/Belgien) 
 

България 
Рош България ЕООД 
Тел: +359 2 818 44 44 
 

Magyarország 
Roche (Magyarország) Kft. 
Tel: +36 - 23 446 800 
 

Česká republika 
Roche s. r. o. 
Tel: +420 - 2 20382111 
 

Malta 
(See United Kingdom) 
 

Danmark 
Roche a/s 
Tlf: +45 - 36 39 99 99 
 

Nederland 
Roche Nederland B.V. 
Tel: +31 (0) 348 438050 
 

Deutschland 
Roche Pharma AG 
Tel: +49 (0) 7624 140 
 

Norge 
Roche Norge AS 
Tlf: +47 - 22 78 90 00 
 

 

 
 

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Eesti 
Roche Eesti OÜ 
Tel: + 372 - 6 177 380 
 

Österreich 
Roche Austria GmbH 
Tel: +43 (0) 1 27739 
 

Ελλάδα 
Roche (Hellas) A.E.  
Τηλ: +30 210 61 66 100 
 

Polska 
Roche Polska Sp.z o.o. 
Tel: +48 - 22 345 18 88 
 

España 
Roche Farma S.A. 
Tel: +34 - 91 324 81 00 
 

Portugal 
Roche Farmacêutica Química, Lda 
Tel: +351 - 21 425 70 00 
 

France 
Roche 
Tél: +33 (0) 1 47 61 40 00 
 

România 
Roche România S.R.L. 
Tel: +40 21 206 47 01 
 

Ireland 
Roche Products (Ireland) Ltd. 
Tel: +353 (0) 1 469 0700 
 

Slovenija 
Roche farmacevtska družba d.o.o. 
Tel: +386 - 1 360 26 00 
 

Ísland  
Roche a/s 
c/o Icepharma hf 
Sími: +354 540 8000 
 

Slovenská republika  
Roche Slovensko, s.r.o. 
Tel: +421 - 2 52638201 
 

Italia 
Roche S.p.A. 
Tel: +39 - 039 2471 
 

Suomi/Finland 
Roche Oy  
Puh/Tel: +358 (0) 10 554 500 
 

Kύπρος  
Γ.Α.Σταµάτης & Σια Λτδ. 
Τηλ: +357 – 22 25 72 00 
 

Sverige 
Roche AB 
Tel: +46 (0) 8 726 1200 
 

Latvija 
Roche Latvija SIA 
Tel: +371 – 6 7039831 
 

United Kingdom 
Roche Products Ltd. 
Tel: +44 (0) 1707 366000 
 

Lietuva 
UAB “Roche Lietuva” 
Tel: +370 5 2546799 
 

 

 
 
This leaflet was last approved in {MM/YYYY}. 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu/. There are also links to other websites about rare diseases and treatments. 
 

 

 
 

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http://www.ema.europa.eu


68 

PACKAGE LEAFLET: INFORMATION FOR THE USER 
 

VIRACEPT 250 mg film-coated tablets 
Nelfinavir 

 
Read all of this leaflet carefully before you start taking this medicine. 
• Keep this leaflet. You may need to read it again. 
• If you have any further questions, ask your doctor or pharmacist. 
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even 

if their symptoms are the same as yours. 
• If any of the side effects become serious or troublesome, or if you notice any side effects not 

listed in this leaflet, please tell your doctor or pharmacist. 
 
 
In this leaflet: 
1. What Viracept is and what it is used for 
2. Before you take Viracept 
3. How to take Viracept 
4. Possible side effects 
5. How to store Viracept 
6. Further information 
 
 
 
1. WHAT VIRACEPT IS AND WHAT IT IS USED FOR 
 
What Viracept is 
Viracept contains a medicine called nelfinavir, which is a ‘protease inhibitor’.  This belongs to a group 
of medicines called ‘anti-retrovirals’.  
 
What Viracept is used for 
Viracept is used with other ‘anti-retroviral’ medicines to: 
• Work against the Human Immunodeficiency Virus (HIV). It helps to reduce the number of HIV 

particles in your blood. 
• Increase the number of some cells in your blood that help fight infection. These are called CD4 

white blood cells. They are particularly reduced in numbers when you have HIV infection. This 
can lead to an increased risk of many types of infections. 

 
Viracept is not a cure for HIV infection. You may continue to get infections or other illnesses due to 
your HIV. Treatment with Viracept does not stop you giving HIV to others through contact with blood 
or sexual contact. Therefore you must keep taking appropriate precautions to avoid giving the virus to 
others when you are taking Viracept. 
 
 
2. BEFORE YOU TAKE VIRACEPT 
 
Do not take Viracept if: 
• You are allergic to nelfinavir or to any of the other ingredients (listed in Section 6 ‘Further 

information’). 
• You are taking any of the medicines listed in the first part of Section 2 ‘Taking other 

medicines’, ‘Do not take Viracept’. 
Do not take Viracept if any of the above apply to you.  
 

 

 
 

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Take special care with Viracept 
Check with your doctor or pharmacist before taking Viracept if: 
• You have kidney problems. 
• You have high blood sugar (diabetes). 
• You have a rare blood problem which runs in families called ‘haemophilia’. 
• You have liver disease caused by hepatitis B or C. Your doctor may wish to carry out regular 

blood tests.  
If any of the above apply to you, or if you are not sure, talk to your doctor or pharmacist before you 
take Viracept. 
 
Patients with liver disease 
Patients with chronic hepatitis B or C and treated with anti-retroviral agents are at increased risk for 
severe and potentially fatal liver adverse events and may require blood tests for control of liver 
function. Speak with your doctor if you have a history of liver disease. 
 
Body fat 
Combination anti-retroviral therapy may cause changes in body shape due to changes in fat 
distribution. These may include loss of fat from legs, arms and face, increased fat in the abdomen 
(belly) and other internal organs, breast enlargement and fatty lumps on the back of the neck (‘buffalo 
hump’). The cause and long-term health effects of these conditions are not known at this time. Contact 
your doctor if you notice changes in body fat. 
 
Signs of previous infections 
In some patients with advanced HIV infection and a history of opportunistic infection, signs and 
symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is 
started. It is believed that these symptoms are due to an improvement in the body’s immune response, 
enabling the body to fight infections that may have been present with no obvious symptoms. If you 
notice any symptoms of infection, please inform your doctor immediately.  
 
Bone disease (osteonecrosis) 
Some patients taking combination anti-retroviral therapy may develop a bone disease called 
osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). The length of 
combination anti-retroviral therapy, corticosteroid use, alcohol consumption, severe 
immunosuppression, higher body mass index, among others, may be some of the many risk factors for 
developing this disease. Signs of osteonecrosis are joint stiffness, aches and pains (especially of the 
hip, knee and shoulder) and difficulty in movement. If you notice any of these symptoms please 
inform your doctor immediately. 
 
Taking other medicines 
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This 
includes medicines that you buy without a prescription and herbal medicines. This is because Viracept 
can affect the way some other medicines work. Also some other medicines can affect the way Viracept 
works. 
 
Do not take Viracept and tell your doctor or pharmacist if you are taking any of the following 
medicines: 
• Medicines made from ergot such as cabergoline, ergotamine or lisuride (for Parkinson’s disease 

or migraine) 
• Herbal preparations containing St. John’s Wort (for depression or improving your mood)  
• Rifampicin (for tuberculosis (TB)) 
• Terfenadine or astemizole (for allergy) 
• Pimozide (used for mental health problems) 
• Amiodarone or quinidine (for an uneven heart beat) 
• Phenobarbital or carbamazepine (for fits or epilepsy) 
• Triazolam or oral midazolam taken by mouth (for anxiety or to help you sleep) 
• Cisapride (for heart burn or problems with your digestive system) 

 

 
 

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• Omeprazole (for ulcers in your stomach or gut) 
• Alfuzosin (for benign prostatic hyperplasia (BPH)) 
• Sildenafil (for pulmonary arterial hypertension (PAH)) 
• Simvastatin or lovastatin (for lowering blood cholesterol) 
 
Do not take Viracept and tell your doctor or pharmacist if any of these apply to you. If you are not 
sure, talk to your doctor or pharmacist before taking Viracept. 
 
Tell your doctor or pharmacist if you are taking any of the following medicines: 
• Any other medicines for HIV infection such as ritonavir, indinavir, saquinavir and delavirdine, 

amprenavir, efavirenz or nevirapine 
• Oral contraceptives (the pill). Viracept can stop the pill from working, so you should use other 

contraception methods (such as condoms) while you are taking Viracept. 
• Calcium channel blockers such as bepridil (for heart problems)  
• Immunosuppressant medicines such as tacrolimus or ciclosporin 
• Medicines that lower stomach acid such as lansoprazole 
• Fluticasone (for hay fever) 
• Phenytoin (for fits or epilepsy) 
• Methadone (for drug dependence) 
• Sildenafil (for getting or keeping an erection) 
• Tadalafil (for pulmonary arterial hypertension (PAH), or for getting or keeping an erection) 
• Vardenafil (for pulmonary arterial hypertension (PAH), or for getting or keeping an erection) 
• Ketoconazole, itraconazole or fluconazole (for fungal infections) 
• Rifabutin, erythromycin or clarithromycin (for bacterial infections) 
• Midazolam given by injection or diazepam (for anxiety or to help you sleep) 
• Fluoxetine, paroxetine, imipramine, amitriptyline or trazodone (for depression) 
• Atorvastatin or other statins (for lowering blood cholesterol) 
• Salmeterol (for asthma or chronic obstructive pulmonary disease (COPD) 
• Warfarin (for lowering the chance of blood clots in your body) 
• Colchicine (for gout-flares or Mediterranean fever) 
• Bosentan (for pulmonary arterial hypertension (PAH)) 
If any of the above apply to you, or if you are not sure, talk to your doctor or pharmacist before you 
take Viracept.  
 
Taking Viracept with food and drink 
Take Viracept with a meal. This helps your body to get the full benefit from your medicine. 
 
Pregnancy, contraception and breast-feeding 
• Talk to your doctor before you take Viracept if you are pregnant or planning to become 

pregnant. 
• Do not breast-feed while taking Viracept because HIV may be passed to the baby. 
• Viracept can stop oral contraceptives (the pill) from working, so you should use other  

contraception methods (such as condoms) while you are taking Viracept. 
• Ask your doctor or pharmacist for advice before taking any medicine.  
 
Driving and using machines 
Viracept is not likely to affect you being able to drive or use any tools or machines. 
 
 
3. HOW TO TAKE VIRACEPT 
 
Always take Viracept exactly as your doctor has told you. You should check with your doctor or 
pharmacist if you are unsure. The usual doses are described below. Follow the instructions carefully to 
get the most benefit from Viracept. 
 

 

 
 

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The Viracept tablets must be taken by mouth. They should be swallowed whole and taken with a meal. 
For adults or children unable to take tablets, Viracept tablets may be put into water and taken as 
follows: 

• Put the tablets in a half cup of water and stir with a spoon.  
• Once the tablet is dispersed, mix the cloudy bluish liquid thoroughly and take immediately.  
• Rinse the glass with a half cup of water and swallow the rinse to ensure all of the dose is 

taken.  
 
Acidic food or juice (such as orange juice, apple juice or apple sauce) are not recommended to be 
taken with Viracept because together they may have a bitter taste. 
 
Alternatively, Viracept 50 mg/g oral powder may be taken instead. If you want to take the powder 
instead please see the Package Leaflet for Viracept 50 mg/g oral powder. 
 
Taking this medicine 
• Take Viracept with a meal. This helps your body to get the full benefit from your 

medicine. 
• Take all your doses at the right time each day. This helps make your medicine work as well as it 

can. 
• Do not stop taking this medicine without talking to your doctor first. 
 
How much to take 
 
Adults and children older than 13 years 
 
Viracept tablets can be taken either two or three times a day with a meal. Table 1 below shows the 
usual doses. 

 

Table 1 
Dose to be taken by adults and children older than 13 years 
 
How often 
you take it 
 

Number of tablets How much you take 
each time (in 
milligrams) 

Two times a 
day 
 

5 1250 mg 

Three times a 
day 

3 750 mg 

 
Children aged 3 to 13 years 
For children aged 3 to 13 years, the recommended dose of Viracept tablets is based on their body 
weight. Carefully monitor the increase in weight of your child to ensure the appropriate total daily 
dose is taken.  
• When your child weighs 18 kg or more, you may provide the tablets either two or three times a 

day.  
• When your child weighs 18 kg or less, you must provide the tablets three times a day. 
 
The different ways are shown in separate tables below.  
 
• Table 2: if you give the medicine two times a day (for children who weigh 18 kg or more), you 

will give 50-55 mg nelfinavir each time for each kg of body weight.  

 

 
 

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• Table 3: if you give the medicine three times a day, you will give 25-35 mg nelfinavir each time 
for each kg of body weight, except for children who weigh from 10.5 to 12 kg, from 12 to 14 
kg and from 18 to 22 kg. These children will be given a different number of tablets with each 
meal. The table also shows the recommended total number of Viracept tablets that children will be 
given each day based on their weight. 

 

Table 2 
Dose to be given two times a day to children aged 3 to 13 

who weigh more than 18 kg 
Body weight of your 
child 

Number of tablets  

18 to 22 kg 4 
over 22 kg 5 

 

Table 3 
Dose to be given three times a day to children aged 3 to 13  

who weigh more than 7.5 kg 
Recommended number of tablets given at 

each meal 
Body weight of 
your child  

Number of 
tablets at 
breakfast 

Number of 
tablets at lunch

Number of 
tablets at 

dinner 

Total number 
of tablets per 

day 

  7.5 to   8.5 kg 1 1 1 3 
  8.5 to 10.5 kg 1 1 1 3 
10.5 to 12   kg* 2 1 1 4 
12    to 14   kg* 2 1 2 5 
14    to 16   kg 2 2 2 6 
16    to 18   kg 2 2 2 6 
18    to 22   kg* 3 2 2 7 
    over 22   kg 3 3 3 9 
* Children with these weights will be given an uneven number of tablets during the day.  Your 
doctor should monitor the number of HIV particles and the number of CD4 white blood cells in 
your child’s blood to assure the medicine works as well as it can. 
 
It is very important that the correct number of tablets be taken at each dose. You should monitor your 
child to assure that the recommended number of tablets are taken at each dose with meals, for each 
weight band. 
 
If you take more Viracept than you should 
If you take more Viracept than you should, talk to a doctor or pharmacist or go to a hospital straight 
away. Take the medicine pack with you. Among other things, very large doses of Viracept might 
cause problems with your heart rhythm. 
 
If you forget to take Viracept 
If you forget to take a dose, take it as soon as you remember it.  
• However if it is nearly time for your next dose, skip the missed dose. 
• Do not take a double dose to make up for a forgotten dose. 
 
If you stop taking Viracept 
Do not stop taking this medicine without talking to your doctor first. Take all your doses at the right 
time each day. This helps make your medicine work as well as it can. 
 
 

 

 
 

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4. POSSIBLE SIDE EFFECTS 
 
Like all medicines, Viracept can have side effects, although not everybody gets them. The following 
side effects may happen with this medicine. 
 
Contact your doctor straight away if you notice any of the following side effects: 

• Allergic reactions. The signs may include difficulty in breathing, fever, itching, swelling of the 
face and skin rashes that can sometimes form blisters. 

• Increased bleeding if you have haemophilia. If you have haemophilia type A or B, in rare 
cases your bleeding may increase.  

• Bone disease (osteonecrosis). The signs may include joint stiffness, aches and pains (especially 
of the hip, knee and shoulder) and difficulty in movement. Some patients taking combination 
anti-retroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue 
caused by loss of blood supply to the bone).  

• Infection. In some patients with advanced HIV infection and a history of opportunistic 
infection, signs and symptoms of inflammation from previous infections may occur soon after 
anti-HIV treatment is started. It is believed that these symptoms are due to an improvement in 
the body’s immune response, enabling the body to fight infections that may have been present 
with no obvious symptoms.  

 
If you notice any of the above, contact your doctor straight away. 
 
Other possible side effects, where you should talk to your doctor 
If you get any of the side effects on this list, or if you notice any side effects not listed in this leaflet, 
please tell your doctor. 
 
Very common (affect more than 1 in 10 people): 
• Diarrhoea. 
 
Common (affect less than 1 in 10 people): 
• Rash. 
• Wind. 
• Feeling sick.  
• Low numbers of a type of white blood cell that fights infections (neutrophils). 
• Abnormal results from blood tests that measure how well your liver or muscles are working. 
 
Uncommon (affect less than 1 in 100 people): 
• Being sick. 
• Pancreatitis. The signs include severe pains in your stomach that spread to your back. 
• Combination anti-retroviral therapy may cause changes in body shape due to changes in fat 

distribution. These may include loss of fat from legs, arms and face, increased fat in the 
abdomen (belly) and other internal organs, breast enlargement and fatty lumps on the back of 
the neck (‘buffalo hump’). The cause and long-term health effects of these conditions are not 
known at this time.  

 
Rare (affect less than 1 in 1000 people): 
• Yellow skin or eyes. This could be a sign of a liver problem such as hepatitis or jaundice. 
• A severe form of rash (erythema multiforme). 
• Swelling of your belly (abdomen). 
• High blood sugar (diabetes) or diabetes get worse. 
• There have been rare reports of muscle pain, tenderness or weakness, particularly with 

combination anti-retroviral therapy including protease inhibitors and nucleoside analogues. On 
rare occasions these muscle problems have been serious causing muscle degeneration 
(rhabdomyolysis). 

 

 

 
 

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Other side effects which have also been reported: 
• Combination anti-retroviral therapy may also cause raised lactic acid and sugar in the blood, 

hyperlipaemia (increased fats in the blood) and resistance to insulin. 
• Low numbers of red blood cells (anaemia). 
• Lung disease (pneumonia). 
• Cases of diabetes mellitus or increased blood sugar levels have been reported in patients  

receiving this treatment or another protease inhibitor. 
 
Side effects in children 
About 400 children (aged from 0 to 13 years) received Viracept in clinical trials. The side effects seen 
in children are similar to those seen in adults. The most commonly reported side effect in children is 
diarrhoea. The side effects only rarely resulted into having to stop taking Viracept. 
 
 
5. HOW TO STORE VIRACEPT 
 
• Keep out of the reach and sight of children. 
• Do not use after the expiry date stated on the label and carton. 
• Do not store above 30°C. 
• Store in the original container. 
 
 
6. FURTHER INFORMATION 
 
What Viracept contains 
• The active substance in Viracept is nelfinavir.  Each tablet contains 250 mg of nelfinavir.  
• The other ingredients are calcium silicate, crospovidone, magnesium stearate, indigo carmine  

(E132), as powder, hypromellose and glycerol triacetate. 
 
What Viracept looks like and contents of the pack 
Viracept film-coated tablets is supplied in plastic bottles with plastic child resistant lid. Each bottle 
contains either 270 or 300 tablets. Not all pack sizes may be marketed.  
 
 
Marketing Authorisation Holder and Manufacturer 
 
Roche Registration Limited 
6 Falcon Way 
Shire Park 
Welwyn Garden City 
AL7 1TW 
United Kingdom 
 
Manufacturer 
 
Roche Pharma AG 
Emil-Barell-Str. 1 
D-79639 Grenzach-Wyhlen 
Germany 
 

 

 
 

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For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
N.V. Roche S.A. 
Tél/Tel: +32 (0) 2 525 82 11 
 

Luxembourg/Luxemburg 
(Voir/siehe Belgique/Belgien) 
 

България 
Рош България ЕООД 
Тел: +359 2 818 44 44 
 

Magyarország 
Roche (Magyarország) Kft. 
Tel: +36 - 23 446 800 
 

Česká republika 
Roche s. r. o. 
Tel: +420 - 2 20382111 
 

Malta 
(See United Kingdom) 
 

Danmark 
Roche a/s 
Tlf: +45 - 36 39 99 99 
 

Nederland 
Roche Nederland B.V. 
Tel: +31 (0) 348 438050 
 

Deutschland 
Roche Pharma AG 
Tel: +49 (0) 7624 140 
 

Norge 
Roche Norge AS 
Tlf: +47 - 22 78 90 00 
 

Eesti 
Roche Eesti OÜ 
Tel: + 372 - 6 177 380 
 

Österreich 
Roche Austria GmbH 
Tel: +43 (0) 1 27739 
 

Ελλάδα 
Roche (Hellas) A.E.  
Τηλ: +30 210 61 66 100 
 

Polska 
Roche Polska Sp.z o.o. 
Tel: +48 - 22 345 18 88 
 

España 
Roche Farma S.A. 
Tel: +34 - 91 324 81 00 
 

Portugal 
Roche Farmacêutica Química, Lda 
Tel: +351 - 21 425 70 00 
 

France 
Roche 
Tél: +33 (0) 1 47 61 40 00 
 

România 
Roche România S.R.L. 
Tel: +40 21 206 47 01 
 

Ireland 
Roche Products (Ireland) Ltd. 
Tel: +353 (0) 1 469 0700 
 

Slovenija 
Roche farmacevtska družba d.o.o. 
Tel: +386 - 1 360 26 00 
 

Ísland  
Roche a/s 
c/o Icepharma hf 
Sími: +354 540 8000 
 

Slovenská republika  
Roche Slovensko, s.r.o. 
Tel: +421 - 2 52638201 
 

Italia 
Roche S.p.A. 
Tel: +39 - 039 2471 
 

Suomi/Finland 
Roche Oy  
Puh/Tel: +358 (0) 10 554 500 
 

Kύπρος  
Γ.Α.Σταµάτης & Σια Λτδ. 
Τηλ: +357 – 22 25 72 00 
 

Sverige 
Roche AB 
Tel: +46 (0) 8 726 1200 
 

 

 
 

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Latvija 
Roche Latvija SIA 
Tel: +371 - 6 7039831 
 

United Kingdom 
Roche Products Ltd. 
Tel: +44 (0) 1707 366000 
 

Lietuva 
UAB “Roche Lietuva” 
Tel: +370 5 2546799 
 

 

 
 
This leaflet was last approved in {MM/YYYY}. 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu/. There are also links to other websites about rare diseases and treatments. 

 

 
 

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http://www.ema.europa.eu

	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OF THE MARKETING AUTHORISATION
	A. LABELLING
	B. PACKAGE LEAFLET
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{'Title': '2. before you take viracept', 'Section_Content': "do not take viracept if: you are allergic to nelfinavir or to any of the other ingredients (listed in section 6 'further information'). you are taking any of the medicines listed in the first part of section 2 'taking other medicines', 'do not take viracept'. do not take viracept if any of the above apply to you. take special care with viracept check with your doctor or pharmacist before taking viracept if: you have kidney problems. you have high blood sugar (diabetes). you have a rare blood problem which runs in families called 'haemophilia'. you have liver disease caused by hepatitis b or c. your doctor may wish to carry out regular blood tests. if any of the above apply to you, or if you are not sure, talk to your doctor or pharmacist before you take viracept. patients with liver disease patients with chronic hepatitis b or c and treated with anti-retroviral agents are at increased risk for severe and potentially fatal 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other medicines can affect the way viracept works. do not take viracept and tell your doctor or pharmacist if you are taking any of the following medicines: medicines made from ergot such as cabergoline, ergotamine or lisuride (for parkinson's disease or migraine) herbal preparations containing st. john's wort (for depression or improving your mood) rifampicin (for tuberculosis (tb)) terfenadine or astemizole (for allergy) pimozide (used for mental health problems) amiodarone or quinidine (for an uneven heart beat) phenobarbital or carbamazepine (for fits or epilepsy) triazolam or oral midazolam taken by mouth (for anxiety or to help you sleep) cisapride (for heart burn or problems with your digestive system) 61 omeprazole (for ulcers in your stomach or gut) alfuzosin (for benign prostatic hyperplasia (bph)) sildenafil (for pulmonary arterial hypertension (pah)) simvastatin or lovastatin (for lowering blood cholesterol) do not take viracept and tell your doctor or pharmacist if any of these apply to you. if you are not sure, talk to your doctor or pharmacist before taking viracept. tell your doctor or pharmacist if you are taking any of the following medicines: any other medicines for hiv infection such as ritonavir, indinavir, saquinavir and delavirdine, amprenavir, efavirenz or nevirapine oral contraceptives (the pill). viracept can stop the pill from working, so you should use other contraception methods (such as condoms) while you are taking viracept. calcium channel blockers such as bepridil (for heart problems) immunosuppressant medicines such as tacrolimus or ciclosporin medicines that lower stomach acid such as lansoprazole fluticasone (for hay fever) phenytoin (for fits or epilepsy) methadone (for drug dependence) sildenafil (for getting or keeping an erection) tadalafil (for pulmonary arterial hypertension (pah), or for getting or keeping an erection) vardenafil (for pulmonary arterial hypertension (pah), or for getting or keeping an erection) ketoconazole, itraconazole or fluconazole (for fungal infections) rifabutin, erythromycin or clarithromycin (for bacterial infections) midazolam given by injection or diazepam (for anxiety or to help you sleep) fluoxetine, paroxetine, imipramine, amitriptyline or trazodone (for depression) atorvastatinor other statins(for lowering blood cholesterol) salmeterol (for asthma or chronic obstructive pulmonary disease (copd)) warfarin (for lowering the chance of blood clots in your body) colchicine (for gout-flares or mediterranean fever) bosentan (for pulmonary arterial hypertension (pah) ) if any of the above apply to you, or if you are not sure, talk to your doctor or pharmacist before you take viracept. taking viracept with food and drink take viracept with a meal. this helps your body to get the full benefit from your medicine. pregnancy, contraception and breast-feeding talk to your doctor before you take viracept if you are pregnant or planning to become pregnant. do not breast-feed while taking viracept because hiv may be passed to the baby. viracept can stop oral contraceptives (the pill) from working, so you should use other contraception methods (such as condoms) while you are taking viracept. ask your doctor or pharmacist for advice before taking any medicine. driving and using machines viracept is not likely to affect you being able to drive or use any tools or machines. important information about some of the ingredients of viracept this medicine contains sucrose, which is a type of sugar. if you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine. each dose contains up to 5.9 milligrams of sucrose, which should be taken into account in patients with diabetes mellitus. this medicine contains aspartame, which is a source of phenylalanine. this may be harmful for people with phenylketonuria. this medicine is essentially 'potassium-free' as it 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{'Title': '3. how to take viracept', 'Section_Content': 'always take viracept exactly as your doctor has told you. you should check with your doctor or pharmacist if you are unsure. the usual doses are described below. follow the instructions carefully to get the most benefit from viracept. viracept powder is for people who cannot take tablets. viracept tablets are generally recommended for adults and older children. for younger children able to take tablets, viracept tablets may be taken instead of the oral powder. if you want to take the tablets instead please see the package leaflet for viracept 250 mg tablets. how to prepare viracept two measuring scoops are provided in the medicine box: white 1 gram (1g) scoop. blue 5 gram (5g) scoop. measure out a level scoop of powder. you can use the handle of the second scoop to scrape off the extra powder and make your scoop level (see picture below). you can mix the powder with a small amount of water, milk, baby formula, soy formula, soy milk, dietary liquid supplements or pudding. if you mix the powder, but do not take it straight away you can store it for up to 6 hours in a refrigerator. do not mix the powder with orange juice, apple sauce or other acidic liquids or foods. this may give your medicine a bitter taste. do not add liquid to the powder in its original container taking this medicine take viracept with a meal. this helps your body to get the full benefit from your medicine. take all the mixture you make each time. this will make sure that you get the right amount of your medicine. take all your doses at the right time each day. this helps make your medicine work as well as it can. do not stop taking this medicine without talking to your doctor first. how much to take adults and children older than 13 years viracept powder can be taken either two or three times a day with a meal. table 1 below shows the usual doses. table 1 dose to be taken by adults and children older than 13 years how often you take it number of scoops blue scoop white scoop (5 g) (1 g) how much you take each time (in grams) two times a day 5 - 25 g three times a day 3 - 15 g children aged 3 to 13 years for children aged 3 to 13 years, the recommended dose of viracept powder is based on their body weight. you will either give the medicine to your child two or three times a day with a meal. the different ways are shown in separate tables below. table 2: if you give the medicine two times a day, you will give 50-55 mg nelfinavir each time for each kg of body weight. table 3: if you give the medicine three times a day, you will give 25-35 mg nelfinavir each time for each kg of body weight. table 2 dose to be given two times a day to children aged 3 to 13 body weight of your child number of scoops blue scoop white scoop (5 g) (1 g) how much to give each time (in grams) 7.5 to 8.5 kg 1 plus 3 8 g 8.5 to 10.5 kg 2 - 10 g 10.5 to 12 kg 2 plus 2 12 g 12 to 14 kg 2 plus 4 14 g 14 to 16 kg 3 plus 1 16 g 16 to 18 kg 3 plus 3 18 g 18 to 22 kg 4 plus 1 21 g over 22 kg 5 - 25 g 64 table 3 dose to be given three times a day to children aged 3 to 13 body weight of your child number of scoops blue scoop white scoop (5 g) (1 g) how much to give each time (in grams) 7.5 to 8.5 kg 1 5 g 8.5 to 10.5 kg 1 plus 1 6 g 10.5 to 12 kg 1 plus 2 7 g 12 to 14 kg 1 plus 3 8 g 14 to 16 kg 2 10 g 16 to 18 kg 2 plus 1 11 g 18 to 22 kg 2 plus 3 13 g over 22 kg 3 15 g if you take more viracept than you should if you take more viracept than you should, talk to a doctor or pharmacist or go to a hospital straight away. take the medicine pack with you. among other things, very large doses of viracept might cause problems with your heart rhythm. if you forget to take viracept if you forget to take a dose, take it as soon as you remember it. however if it is nearly time for your next dose, skip the missed dose. do not take a double dose to make up for a forgotten dose. if you stop taking viracept do not stop taking this medicine without 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{'Title': '4. possible side effects', 'Section_Content': "like all medicines, viracept can have side effects, although not everybody gets them. the following side effects may happen with this medicine. contact your doctor straight away if you notice any of the following side effects: allergic reactions. the signs may include difficulty in breathing, fever, itching, swelling of the face and skin rashes that can sometimes form blisters. increased bleeding if you have haemophilia. if you have haemophilia type a or b, in rare cases your bleeding may increase. bone disease (osteonecrosis). the signs may include joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement. some patients taking combination anti-retroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). infection. in some patients with advanced hiv infection and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-hiv treatment is started. it is believed that these symptoms are due to an improvement in the body's immune response, enabling the body to fight infections that may have been present with no obvious symptoms. if you notice any of the above, contact your doctor straight away. other possible side effects, where you should talk to your doctor if you get any of the side effects on this list, or if you notice any side effects not listed in this leaflet, please tell your doctor. very common (affect more than 1 in 10 people): diarrhoea. common (affect less than 1 in 10 people): rash. wind. feeling sick. low numbers of a type of white blood cell that fights infections (neutrophils). abnormal results from blood tests that measure how well your liver or muscles are working. uncommon (affect less than 1 in 100 people): being sick. pancreatitis. the signs include severe pains in your stomach that spread to your back. combination anti-retroviral therapy may cause changes in body shape due to changes in fat distribution. these may include loss of fat from legs, arms and face, increased fat in the abdomen (belly) and other internal organs, breast enlargement and fatty lumps on the back of the neck ('buffalo hump'). the cause and long-term health effects of these conditions are not known at this time. rare (affect less than 1 in 1000 people): yellow skin or eyes. this could be a sign of a liver problem such as hepatitis or jaundice. a severe form of rash (erythema multiforme). swelling of your belly (abdomen). high blood sugar (diabetes) or diabetes get worse. there have been rare reports of muscle pain, tenderness or weakness, particularly with combination anti-retroviral therapy including protease inhibitors and nucleoside analogues. on rare occasions these muscle problems have been serious causing muscle degeneration (rhabdomyolysis). other side effects which have also been reported: combination anti-retroviral therapy may also cause raised lactic acid and sugar in the blood, hyperlipaemia (increased fats in the blood) and resistance to insulin. low numbers of red blood cells (anaemia). lung disease (pneumonia). cases of diabetes mellitus or increased blood sugar levels have been reported in patients receiving this treatment or another protease inhibitor. side effects in children about 400 children (aged from 0 to 13 years) received viracept in clinical trials. the side effects seen in children are similar to those seen in adults. the most commonly reported side effect in children is diarrhoea. the side effects only rarely resulted into having to stop taking viracept.", 'Entity_Recognition': [{'Text': 'viracept', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'all medicines', 'Type': 'TREATMENT', 'BeginOffset': 5, 'EndOffset': 18}, {'Id': 15, 'BeginOffset': 20, 'EndOffset': 28, 'Score': 0.7547327280044556, 'Text': 'viracept', 'Category': 'MEDICATION', 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{'Title': '5. how to store viracept', 'Section_Content': ' keep out of the reach and sight of children. do not use after the expiry date stated on the label and carton. do not store above 30. store in the original container. the mixed solution can be stored for up to 6 hours in a refrigerator.', 'Entity_Recognition': [{'Text': 'viracept', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': '30.', 'Type': 'NUMBER', 'BeginOffset': 130, 'EndOffset': 133}, {'Text': 'the mixed solution', 'Type': 'TREATMENT', 'BeginOffset': 167, 'EndOffset': 185}, {'Text': '6', 'Type': 'NUMBER', 'BeginOffset': 210, 'EndOffset': 211}]}
{'Title': '6. further information', 'Section_Content': 'what viracept contains the active substance in viracept is nelfinavir. each gram of oral powder contains an amount of nelfinavir mesilate that makes 50 mg of nelfinavir. the other ingredients are microcrystalline cellulose, maltodextrin, dibasic potassium phosphate, crospovidone, hydroxypropyl methylcellulose, aspartame (e951), sucrose palmitate, and natural and artificial flavour. what viracept looks like and contents of the pack viracept 50 mg/g oral powder is a white to off-white powder. it is supplied in plastic bottles with plastic child resistant lids. each bottle contains 144 grams of powder and is supplied with a 1 gram scoop (white) and a 5 gram scoop (blue).', 'Entity_Recognition': [{'Text': 'viracept', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 0, 'BeginOffset': 5, 'EndOffset': 13, 'Score': 0.6525298953056335, 'Text': 'viracept', 'Category': 'MEDICATION', 'Type': 'BRAND_NAME', 'Traits': []}, 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