Pifeltro
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ANNEX I

SUMMARY OF PRODUCT CHARACTERISTICS

 



2

This medicinal product is subject to additional monitoring. This will allow quick identification of 
new safety information. Healthcare professionals are asked to report any suspected adverse reactions. 
See section 4.8 for how to report adverse reactions.

1. NAME OF THE MEDICINAL PRODUCT

Pifeltro 100 mg film-coated tablets.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each film-coated tablet contains 100 mg of doravirine.

Excipient with known effect
Each film-coated tablet contains 222 mg lactose (as monohydrate).

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Film-coated tablet

White, oval-shaped, tablet of dimensions 19.00 mm x 9.50 mm, debossed with the corporate logo and 
700 on one side and plain on the other side.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Pifeltro is indicated, in combination with other antiretroviral medicinal products, for the treatment of 
adults infected with HIV-1 without past or present evidence of resistance to the NNRTI class (see 
sections 4.4 and 5.1).

4.2 Posology and method of administration

Therapy should be initiated by a physician experienced in the management of HIV infection.

Posology

The recommended dose is one 100 mg tablet taken orally once daily with or without food.

Dose adjustment
If Pifeltro is co-administered with rifabutin, one 100 mg tablet of Pifeltro should be taken twice daily 
(approximately 12 hours apart) (see section 4.5).

Co-administration of doravirine with other moderate CYP3A inducers has not been evaluated, but 
decreased doravirine concentrations are expected. If co-administration with other moderate CYP3A 
inducers (e.g., dabrafenib, lesinurad, bosentan, thioridazine, nafcillin, modafinil, telotristat ethyl) 
cannot be avoided, one 100 mg tablet of Pifeltro should be taken twice daily (approximately 12 hours 
apart).

Missed dose
If the patient misses a dose of Pifeltro within 12 hours of the time it is usually taken, the patient should 
take as soon as possible and resume the normal dosing schedule. If a patient misses a dose by more 

 



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than 12 hours, the patient should not take the missed dose and instead take the next dose at the 
regularly scheduled time. The patient should not take 2 doses at one time.

Special populations
Elderly
No dose adjustment of doravirine is needed in elderly patients (see section 5.2).

Renal impairment
No dose adjustment of doravirine is required in patients with mild, moderate, or severe renal 
impairment. Doravirine has not been studied in patients with end-stage renal disease and has not been 
studied in dialysis patients (see section 5.2).

Hepatic impairment
No dose adjustment of doravirine is required in patients with mild (Child-Pugh Class A) or moderate 
(Child-Pugh Class B) hepatic impairment. Doravirine has not been studied in patients with severe 
hepatic impairment (Child-Pugh Class C). It is not known whether the exposure to doravirine will 
increase in patients with severe hepatic impairment. Therefore, caution is advised when doravirine is 
administered to patients with severe hepatic impairment (see section 5.2).

Paediatric population
Safety and efficacy of doravirine have not been established in patients younger than 18 years of age.
No data are available.

Method of administration
Pifeltro must be taken orally, once daily with or without food and swallowed whole (see section 5.2).

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Co-administration with medicinal products that are strong cytochrome P450 CYP3A enzyme inducers
is contraindicated as significant decreases in doravirine plasma concentrations are expected to occur, 
which may decrease the effectiveness of Pifeltro (see sections 4.4 and 4.5). These medicinal products
include, but are not limited, to the following:
 carbamazepine, oxcarbazepine, phenobarbital, phenytoin
 rifampicin, rifapentine
 St. John’s wort (Hypericum perforatum)
 mitotane
 enzalutamide
 lumacaftor

4.4 Special warnings and precautions for use

While effective viral suppression with antiretroviral therapy has been proven to substantially reduce 
the risk of sexual transmission of HIV-1, a residual risk cannot be excluded. Precautions to prevent 
transmission should be taken in accordance with national guidelines.

NNRTI substitutions and use of doravirine
Doravirine has not been evaluated in patients with previous virologic failure to any other antiretroviral 
therapy. NNRTI-associated mutations detected at screening were part of exclusion criteria in the Phase 
2b/3-studies. A breakpoint for a reduction in susceptibility, yielded by various NNRTI substitutions,
that is associated with a reduction in clinical efficacy has not been established (see section 5.1). There 
is not sufficient clinical evidence to support the use of doravirine in patients infected with HIV-1 with 
evidence of resistance to the NNRTI class.

 



4

Use with CYP3A inducers
Caution should be given to prescribing doravirine with medicinal products that may reduce the 
exposure of doravirine (see sections 4.3 and 4.5).

Immune reactivation syndrome
Immune reactivation syndrome has been reported in patients treated with combination antiretroviral 
therapy. During the initial phase of combination antiretroviral treatment, patients whose immune 
system responds may develop an inflammatory response to indolent or residual opportunistic 
infections (such as Mycobacterium avium infection, cytomegalovirus, Pneumocystis jirovecii
pneumonia [PCP], or tuberculosis), which may necessitate further evaluation and treatment.

Autoimmune disorders (such as Graves’ disease, autoimmune hepatitis, polymyositis, and Guillain-
Barré syndrome) have also been reported to occur in the setting of immune reactivation; however, the 
time to onset is more variable and can occur many months after initiation of treatment.

Lactose
The tablets contain lactose monohydrate. Patients with rare hereditary problems of galactose 
intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

4.5 Interaction with other medicinal products and other forms of interaction

Effects of other medicinal products on doravirine
Doravirine is primarily metabolised by CYP3A, and medicinal products that induce or inhibit CYP3A 
are expected to affect the clearance of doravirine (see section 5.2). Doravirine should not be co-
administered with medicinal products that are strong CYP3A enzyme inducers as significant decreases 
in doravirine plasma concentrations are expected to occur, which may decrease the effectiveness of 
doravirine (see sections 4.3 and 5.2).

Co-administration with the moderate CYP3A inducer rifabutin decreased doravirine concentrations
(see Table 1). When doravirine is co-administered with rifabutin, the doravirine dose should be 
increased to 100 mg twice daily (the doses should be taken approximately 12 hours apart) (see 
section 4.2).

Co-administration of doravirine with other moderate CYP3A inducers has not been evaluated, but 
decreased doravirine concentrations are expected. If co-administration with other moderate CYP3A 
inducers (e.g., dabrafenib, lesinurad, bosentan, thioridazine, nafcillin, modafinil, telotristat ethyl) 
cannot be avoided, the doravirine dose should be increased to 100 mg twice daily (the doses should be 
taken approximately 12 hours apart) (see section 4.2).

Co-administration of doravirine and medicinal products that are inhibitors of CYP3A may result in 
increased plasma concentrations of doravirine. However, no dose adjustment is needed when 
doravirine is co-administered with CYP3A inhibitors.

Effects of doravirine on other medicinal products
Doravirine at a dose of 100 mg once daily is not likely to have a clinically relevant effect on the 
plasma concentrations of medicinal products that are dependent on transport proteins for absorption 
and/or elimination or that are metabolized by CYP enzymes.

However, co-administration of doravirine and the sensitive CYP3A substrate midazolam resulted in a 
18 % decrease in midazolam exposure, suggesting that doravirine may be a weak CYP3A inducer. 
Therefore caution should be used when co-administering doravirine with medicinal products that are 
sensitive CYP3A substrates that also have a narrow therapeutic window (e.g., tacrolimus and 
sirolimus).

Interactions table
Table 1 shows the established and other potential medicinal product interactions with doravirine but is 
not all inclusive (increase is indicated as , decrease is indicated as ↓, and no change as ↔).

 



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Table 1: Interactions of doravirine with other medicinal products

Medicinal Product by 
Therapeutic Area

Effects on Medicinal Product 
Levels Geometric Mean Ratio 

(90 % CI)*

Recommendation Concerning 
Co-administration with 

doravirine
Acid-Reducing Agents

antacid (aluminium and 
magnesium hydroxide oral 
suspension)
(20 mL SD,
doravirine 100 mg SD)

 doravirine
AUC 1.01 (0.92, 1.11)
Cmax 0.86 (0.74, 1.01)
C24 1.03 (0.94, 1.12)

No dose adjustment is required.

pantoprazole
(40 mg QD,
doravirine 100 mg SD)

 doravirine
AUC 0.83 (0.76, 0.91)
Cmax 0.88 (0.76, 1.01)
C24 0.84 (0.77, 0.92)

No dose adjustment is required.

omeprazole

Interaction not studied.

Expected:
 doravirine

No dose adjustment is required.

Angiotensin Converting Enzyme Inhibitors

lisinopril

Interaction not studied.

Expected:
↔ lisinopril

No dose adjustment is required.

Antiandrogens

enzalutamide

Interaction not studied.

Expected:
 doravirine
(Induction of CYP3A)

Co-administration is 
contraindicated.

Antibiotics

nafcillin

Interaction not studied.

Expected:
↓ doravirine
(Induction of CYP3A)

Co-administration should be 
avoided. If co-administration 
cannot be avoided, one tablet of 
doravirine should be taken twice 
daily (approximately 12 hours 
apart).

 



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Medicinal Product by 
Therapeutic Area

Effects on Medicinal Product 
Levels Geometric Mean Ratio 

(90 % CI)*

Recommendation Concerning 
Co-administration with 

doravirine
Anticonvulsants

carbamazepine
oxcarbazepine
phenobarbital
phenytoin

Interaction not studied.

Expected:
 doravirine
(Induction of CYP3A)

Co-administration is 
contraindicated.

Antidiabetics

metformin
(1000 mg SD,
doravirine 100 mg QD)

 metformin
AUC 0.94 (0.88, 1.00)
Cmax 0.94 (0.86, 1.03)

No dose adjustment is required.

canagliflozin
liraglutide
sitagliptin

Interaction not studied.

Expected:
↔ canagliflozin
↔ liraglutide
↔ sitagliptin

No dose adjustment is required.

Antidiarrhoeals

telotristat ethyl

Interaction not studied.

Expected:
↓ doravirine
(Induction of CYP3A)

Co-administration should be 
avoided. If co-administration 
cannot be avoided, one tablet of 
doravirine should be taken twice 
daily (approximately 12 hours 
apart).

Antigout and Uricosuric Agents

lesinurad

Interaction not studied.

Expected:
↓ doravirine
(Induction of CYP3A)

Co-administration should be 
avoided. If co-administration 
cannot be avoided, one tablet of 
doravirine should be taken twice 
daily (approximately 12 hours 
apart).

Antimycobacterials

Single dose rifampicin
(600 mg SD,
doravirine 100 mg SD)

Multiple dose rifampicin
(600 mg QD,
doravirine 100 mg SD)

 doravirine
AUC 0.91 (0.78, 1.06)
Cmax 1.40 (1.21, 1.63)
C24 0.90 (0.80, 1.01)

 doravirine
AUC 0.12 (0.10, 0.15)
Cmax 0.43 (0.35, 0.52)
C24 0.03 (0.02, 0.04)
(Induction of CYP3A)

Co-administration is 
contraindicated.

rifapentine

Interaction not studied.

Expected:
 doravirine
(Induction of CYP3A)

Co-administration is 
contraindicated.

rifabutin
(300 mg QD,
doravirine 100 mg SD)

 doravirine
AUC 0.50 (0.45, 0.55)
Cmax 0.99 (0.85, 1.15)
C24 0.32 (0.28, 0.35)
(Induction of CYP3A)

If doravirine is co-administered 
with rifabutin, the doravirine dose 
should be increased to 100 mg 
twice daily (approximately 
12 hours apart).

 



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Medicinal Product by 
Therapeutic Area

Effects on Medicinal Product 
Levels Geometric Mean Ratio 

(90 % CI)*

Recommendation Concerning 
Co-administration with 

doravirine
Antineoplastics

mitotane

Interaction not studied.

Expected:
 doravirine
(Induction of CYP3A)

Co-administration is 
contraindicated.

Antipsychotics

thioridazine

Interaction not studied.

Expected:
↓ doravirine
(Induction of CYP3A)

Co-administration should be 
avoided. If co-administration 
cannot be avoided, one tablet of 
doravirine should be taken twice 
daily (approximately 12 hours 
apart).

Azole Antifungal Agents

ketoconazole
(400 mg QD,
doravirine 100 mg SD)

 doravirine
AUC 3.06 (2.85, 3.29)
Cmax 1.25 (1.05, 1.49)
C24 2.75 (2.54, 2.98)
(Inhibition of CYP3A)

No dose adjustment is required.

fluconazole
itraconazole
posaconazole
voriconazole

Interaction not studied.

Expected:
 doravirine
(Inhibition of CYP3A4)

No dose adjustment is required.

Calcium Channel Blockers

diltiazem
verapamil

Interaction not studied.

Expected:
 doravirine
(CYP3A inhibition)

No dose adjustment is required.

Cystic Fibrosis Treatment

lumacaftor

Interaction not studied.

Expected:
 doravirine
(Induction of CYP3A)

Co-administration is 
contraindicated.

Endothelin Receptor Antagonists

bosentan

Interaction not studied.

Expected:
↓ doravirine
(Induction of CYP3A)

Co-administration should be 
avoided. If co-administration 
cannot be avoided, one tablet of 
doravirine should be taken twice 
daily (approximately 12 hours 
apart).

 



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Medicinal Product by 
Therapeutic Area

Effects on Medicinal Product 
Levels Geometric Mean Ratio 

(90 % CI)*

Recommendation Concerning 
Co-administration with 

doravirine
Hepatitis C Antiviral Agents

elbasvir + grazoprevir
(50 mg elbasvir QD + 200 mg 
grazoprevir QD,
doravirine 100 mg QD)

 doravirine
AUC 1.56 (1.45, 1.68)
Cmax 1.41 (1.25, 1.58)
C24 1.61 (1.45, 1.79)
(Inhibition of CYP3A)

 elbasvir
AUC 0.96 (0.90, 1.02)
Cmax 0.96 (0.91, 1.01)
C24 0.96 (0.89, 1.04)

 grazoprevir
AUC 1.07 (0.94, 1.23)
Cmax 1.22 (1.01, 1.47)
C24 0.90 (0.83, 0.96)

No dose adjustment is required.

ledipasvir + sofosbuvir
(90 mg ledipasvir SD + 
400 mg sofosbuvir SD,
doravirine 100 mg SD)

 doravirine
AUC 1.15 (1.07, 1.24)
Cmax 1.11 (0.97, 1.27)
C24 1.24 (1.13, 1.36)

 ledipasvir
AUC 0.92 (0.80, 1.06)
Cmax 0.91 (0.80, 1.02)

 sofosbuvir
AUC 1.04 (0.91, 1.18)
Cmax 0.89 (0.79, 1.00)

 GS-331007
AUC 1.03 (0.98, 1.09)
Cmax 1.03 (0.97, 1.09)

No dose adjustment is required.

sofosbuvir/velpatasvir

Interaction not studied.

Expected:
 doravirine

No dose adjustment is required.

sofosbuvir

Interaction not studied.

Expected:
 doravirine

No dose adjustment is required.

daclatasvir
Interaction not studied.

Expected:
↔ doravirine

No dose adjustment is required.

ombitasvir/
paritaprevir/ritonavir and 
dasabuvir+/-ritonavir

Interaction not studied.

Expected:
 doravirine
(Inhibition of CYP3A due to 
ritonavir)

No dose adjustment is required.

 



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Medicinal Product by 
Therapeutic Area

Effects on Medicinal Product 
Levels Geometric Mean Ratio 

(90 % CI)*

Recommendation Concerning 
Co-administration with 

doravirine

dasabuvir
Interaction not studied.
Expected:
 doravirine

No dose adjustment is required.

glecaprevir, pibrentasvir

Interaction not studied.

Expected:
 doravirine
(inhibition of CYP3A)

No dose adjustment is required.

ribavirin

Interaction not studied.

Expected:
 doravirine

No dose adjustment is required.

Herbal Supplements

St. John’s wort
(Hypericum perforatum)

Interaction not studied.

Expected:
 doravirine
(Induction of CYP3A)

Co-administration is 
contraindicated.

HIV Antiviral Agents

Fusion and Entry Inhibitors

enfuvirtide

Interaction not studied.

Expected:
↔ doravirine
↔ enfuviritide

No dose adjustment is required.

maraviroc

Interaction not studied.

Expected:
↔ doravirine
↔ maraviroc

No dose adjustment is required.

Protease Inhibitors

ritonavir†- boosted PIs
(atazanavir, darunavir, 
fosamprenavir, indinavir, 
lopinavir, saquinavir, 
tipranavir)

Interaction not studied.

Expected:
 doravirine
(Inhibition of CYP3A)

↔ boosted PIs

No dose adjustment is required.

cobicistat-boosted PIs
(darunavir, atazanavir)

Interaction not studied.

Expected:
 doravirine
(Inhibition of CYP3A)

↔ boosted PIs

No dose adjustment is required.

 



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Medicinal Product by 
Therapeutic Area

Effects on Medicinal Product 
Levels Geometric Mean Ratio 

(90 % CI)*

Recommendation Concerning 
Co-administration with 

doravirine
Integrase Strand Transfer Inhibitors

dolutegravir
(50 mg QD,
doravirine 200 mg QD)

 doravirine
AUC 1.00 (0.89, 1.12)
Cmax 1.06 (0.88, 1.28)
C24 0.98 (0.88, 1.09)

 dolutegravir
AUC 1.36 (1.15, 1.62)
Cmax 1.43 (1.20, 1.71)
C24 1.27 (1.06, 1.53)
(Inhibition of BCRP)

No dose adjustment is required.

raltegravir

Interaction not studied.

Expected:
↔ doravirine
↔ raltegravir

No dose adjustment is required.

ritonavir†-boosted elvitegravir

Interaction not studied.

Expected:
 doravirine
(CYP3A inhibition)

↔ elvitegravir

No dose adjustment is required.

cobicistat-boosted elvitegravir

Interaction not studied.

Expected:
 doravirine
(CYP3A inhibition)
↔ elvitegravir

No dose adjustment is required.

Nucleoside Reverse Transcriptase Inhibitors

tenofovir disoproxil
(245 mg QD,
doravirine 100 mg SD)

 doravirine
AUC 0.95 (0.80, 1.12)
Cmax 0.80 (0.64, 1.01)
C24 0.94 (0.78, 1.12)

No dose adjustment is required.

lamivudine + tenofovir 
disoproxil
(300 mg lamivudine SD + 
245 mg tenofovir disoproxil 
SD,
doravirine 100 mg SD)

 doravirine
AUC 0.96 (0.87, 1.06)
Cmax 0.97 (0.88, 1.07)
C24 0.94 (0.83, 1.06)

 lamivudine
AUC 0.94 (0.88, 1.00)
Cmax 0.92 (0.81, 1.05)

 tenofovir
AUC 1.11 (0.97, 1.28)
Cmax 1.17 (0.96, 1.42)

No dose adjustment is required.

abacavir Interaction not studied.

Expected:
↔ doravirine
↔ abacavir

No dose adjustment is required.

 



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Medicinal Product by 
Therapeutic Area

Effects on Medicinal Product 
Levels Geometric Mean Ratio 

(90 % CI)*

Recommendation Concerning 
Co-administration with 

doravirine

emtricitabine

Interaction not studied.

Expected:
↔ doravirine
↔ emtricitabine

No dose adjustment is required.

tenofovir alafenamide

Interaction not studied.

Expected:
↔ doravirine
↔ tenofovir alafenamide

No dose adjustment is required.

Immunosuppressants

tacrolimus
sirolimus

Interaction not studied. 

Expected:
 doravirine
↓ tacrolimus, sirolimus
(Induction of CYP3A)

Monitor blood concentrations of 
tacrolimus and sirolimus as the 
dose of these agents may need to 
be adjusted. 

Kinase Inhibitors

dabrafenib

Interaction not studied.

Expected:
↓ doravirine
(Induction of CYP3A)

Co-administration should be 
avoided. If co-administration 
cannot be avoided, one tablet of 
doravirine should be taken twice 
daily (approximately 12 hours 
apart).

Opioid Analgesics

methadone
20-200 mg QD individualised 
dose,
doravirine 100 mg QD

 doravirine
AUC 0.74 (0.61, 0.90)
Cmax 0.76 (0.63, 0.91)
C24 0.80 (0.63, 1.03)

 R-methadone
AUC 0.95 (0.90, 1.01)
Cmax 0.98 (0.93, 1.03)
C24 0.95 (0.88, 1.03)

 S-methadone
AUC 0.98 (0.90, 1.06)
Cmax 0.97 (0.91, 1.04)
C24 0.97 (0.86, 1.10)

No dose adjustment is required.

buprenorphine
naloxone

Interaction not studied.

Expected:
↔ buprenorphine
↔ naloxone

No dose adjustment is required.

 



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Medicinal Product by 
Therapeutic Area

Effects on Medicinal Product 
Levels Geometric Mean Ratio 

(90 % CI)*

Recommendation Concerning 
Co-administration with 

doravirine
Oral Contraceptives

0.03 mg ethinyl oestradiol/
0.15 mg levonorgestrel SD,
doravirine 100 mg QD

 ethinyl oestradiol
AUC 0.98 (0.94, 1.03)
Cmax 0.83 (0.80, 0.87)

 levonorgestrel
AUC 1.21 (1.14, 1.28)
Cmax 0.96 (0.88, 1.05)

No dose adjustment is required.

norgestimate/ethinyl 
oestradiol

Interaction not studied.

Expected:
 norgestimate/ethinyl oestradiol

No dose adjustment is required.

Pharmacokinetic Enhancers

ritonavir
(100 mg BID,
doravirine 50 mg SD)

 doravirine
AUC 3.54 (3.04, 4.11)
Cmax 1.31 (1.17, 1.46)
C24 2.91 (2.33, 3.62)
(Inhibition of CYP3A)

No dose adjustment is required.

cobicistat

Interaction not studied.

Expected:
 doravirine
(Inhibition of CYP3A)

No dose adjustment is required.

Psychostimulants

modafinil

Interaction not studied.

Expected:
↓doravirine
(Induction of CYP3A)

Co-administration should be 
avoided. If co-administration 
cannot be avoided, one tablet of 
doravirine should be taken twice 
daily (approximately 12 hours 
apart).

Sedatives/Hypnotics

midazolam
(2 mg SD,
doravirine 120 mg QD)

 midazolam
AUC 0.82 (0.70, 0.97)
Cmax 1.02 (0.81, 1.28)

No dose adjustment is required.

Statins

atorvastatin
(20 mg SD,
doravirine 100 mg QD)

 atorvastatin
AUC 0.98 (0.90, 1.06)
Cmax 0.67 (0.52, 0.85)

No dose adjustment is required.

rosuvastatin
simvastatin

Interaction not studied.
Expected:
↔ rosuvastatin
↔ simvastatin

No dose adjustment is required.

 = increase, ↓ = decrease, ↔ = no change
CI = Confidence Interval; SD = Single Dose; QD = Once Daily; BID = Twice Daily
*AUC0- for single dose, AUC0-24 for once daily.
†The interaction was evaluated with ritonavir only.

 



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4.6 Fertility, pregnancy and lactation

Pregnancy
There are no or limited amount of data from the use of doravirine in pregnant women.

Antiretroviral pregnancy registry
To monitor maternal-foetal outcomes in patients exposed to antiretroviral medicinal products while 
pregnant, an Antiretroviral Pregnancy Registry has been established. Physicians are encouraged to 
register patients in this registry.

Animal studies with doravirine do not indicate direct or indirect harmful effects with respect to 
reproductive toxicity (see section 5.3).

As a precautionary measure, it is preferable to avoid the use of doravirine during pregnancy.

Breast-feeding
It is unknown whether doravirine is excreted in human milk. Available 
pharmacodynamic/toxicological data in animals have shown excretion of doravirine in milk (see 
section 5.3).
Because of the potential for HIV-1 transmission and the potential for serious adverse reactions in 
breast-feeding infants, mothers should be instructed not to breast-feed if they are receiving Pifeltro.

Fertility
No human data on the effect of doravirine on fertility are available. Animal studies do not indicate 
harmful effects of doravirine on fertility at exposure levels higher than the exposure in humans at the 
recommended clinical dose (see section 5.3).

4.7 Effects on ability to drive and use machines

Pifeltro may have a minor influence on the ability to drive or use machines. Patients should be 
informed that fatigue, dizziness, and somnolence have been reported during treatment with doravirine
(see section 4.8). This should be considered when assessing a patient's ability to drive or operate 
machinery.

4.8 Undesirable effects

Summary of the safety profile
The most frequently reported adverse reactions considered possibly or probably related to doravirine
were nausea (4 %) and headache (3 %).

Tabulated summary of adverse reactions
The adverse reactions with suspected (at least possible) relationship to treatment are listed below by 
body system organ class and frequency. Within each frequency grouping, undesirable effects are 
presented in order of decreasing seriousness. Frequencies are defined as very common (≥ 1/10), 
common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) or rare (≥ 1/10,000 to < 1/1,000).

Table 2: Tabulated summary of adverse reactions associated with doravirine used in 
combination with other antiretrovirals

Frequency Adverse reactions

Infections and infestations
Rare rash pustular
Metabolism and nutrition disorders
Uncommon hypophosphataemia
Rare hypomagnesaemia

 



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Frequency Adverse reactions

Psychiatric disorders
Common abnormal dreams, insomnia1

Uncommon nightmare, depression2, anxiety3, irritability, 
confusional state, suicidal ideation

Rare aggression, hallucination, adjustment disorder, 
mood altered, somnambulism

Nervous system disorders
Common headache, dizziness, somnolence
Uncommon disturbance in attention, memory impairment, 

paraesthesia, hypertonia, poor quality sleep
Vascular disorders
Uncommon hypertension
Respiratory, thoracic and mediastinal disorders
Rare dyspnoea, tonsillar hypertrophy
Gastrointestinal disorders
Common nausea, diarrhoea, flatulence, abdominal pain4, 

vomiting
Uncommon constipation, abdominal discomfort5, abdominal 

distension, dyspepsia, faeces soft6, 
gastrointestinal motility disorder7

Rare rectal tenesmus
Skin and subcutaneous tissue disorders 
Common rash8

Uncommon pruritus 
Rare dermatitis allergic, rosacea
Musculoskeletal and connective tissue disorders 
Uncommon myalgia, arthralgia
Rare musculoskeletal pain
Renal and urinary disorders
Rare acute kidney injury, renal disorder, calculus 

urinary, nephrolithiasis 
General disorders and administration site conditions
Common fatigue 
Uncommon asthenia, malaise 
Rare chest pain, chills, pain, thirst
Investigations
Common alanine aminotransferase increased9

Uncommon lipase increased, aspartate aminotransferase 
increased, amylase increased, haemoglobin 
decreased

Rare blood creatine phosphokinase increased
1insomnia includes: insomnia, initial insomnia and sleep disorder
2depression includes: depression, depressed mood, major depression, and persistent depressive disorder
3anxiety includes: anxiety and generalised anxiety disorder
4abdominal pain includes: abdominal pain, and abdominal pain upper
5abdominal discomfort includes: abdominal discomfort, and epigastric discomfort
6faeces soft includes: faeces soft and abnormal faeces
7gastrointestinal motility disorder includes: gastrointestinal motility disorder, and frequent bowel movements
8rash includes: rash, rash macular, rash erythematous, rash generalised, rash maculo-papular, rash papular, and urticarial
9alanine aminotransferase increased includes: alanine aminotransferase increased and hepatocellular injury

Immune reactivation syndrome
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

 



15

infections may arise. Autoimmune disorders (such as Graves’ disease and autoimmune hepatitis) have 
also been reported; however, the reported time to onset is more variable and these events can occur 
many months after initiation of treatment (see section 4.4).

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V.

4.9 Overdose

There is no information on potential acute symptoms and signs of overdose with doravirine.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Antivirals for systemic use, ATC code: J05AG06

Mechanism of action
Doravirine is a pyridinone non-nucleoside reverse transcriptase inhibitor of HIV-1 and inhibits HIV-1 
replication by non-competitive inhibition of HIV-1 reverse transcriptase (RT). Doravirine does not 
inhibit the human cellular DNA polymerases α, ß, and mitochondrial DNA polymerase γ.

Antiviral activity in cell culture
Doravirine exhibited an EC50 value of 12.0±4.4 nM against wild-type laboratory strains of HIV-1 
when tested in the presence of 100 % normal human serum using MT4-GFP reporter cells. Doravirine 
demonstrated antiviral activity against a broad panel of primary HIV-1 isolates (A, A1, AE, AG, B, 
BF, C, D, G, H) with EC50 values ranging from 1.2 nM to 10.0 nM.

Antiviral activity in combination with other HIV antiviral medicinal products
The antiviral activity of doravirine was not antagonistic when combined with the NNRTIs delavirdine, 
efavirenz, etravirine, nevirapine, or rilpivirine; the NRTIs abacavir, didanosine, emtricitabine, 
lamivudine, stavudine, tenofovir disoproxil, or zidovudine; the PIs darunavir or indinavir; the fusion 
inhibitor enfuvirtide; the CCR5 co-receptor antagonist maraviroc; or the integrase strand transfer 
inhibitor raltegravir.

Resistance

In cell culture
Doravirine-resistant strains were selected in cell culture starting from wild-type HIV-1 of different 
origins and subtypes, as well as NNRTI-resistant HIV-1. Observed emergent amino acid substitutions 
in RT included: V106A, V106M, V106I, V108I, F227L, F227C, F227V, H221Y, M230I, L234I, 
P236L, and Y318F. Common NNRTI-resistant mutations (K103N, Y181C) were not selected in the 
in vitro study. V106A (yielding a fold change of around 19) appeared as an initial substitution in 
subtype B virus, and V106A or M in subtype A and C virus. Subsequently F227(L/C/V) or L234I 
emerged in addition to V106 substitution (double mutants yielding a fold change of > 100).

 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


16

In clinical trials
Treatment-naïve adult subjects
The Phase 3 studies, DRIVE-FORWARD and DRIVE-AHEAD, included previously untreated 
patients (n = 747) where the following NNRTI substitutions were part of exclusion criteria: L100I, 
K101E, K101P, K103N, K103S, V106A, V106I, V106M, V108I, E138A, E138G, E138K, E138Q, 
E138R, V179L, Y181C, Y181I, Y181V, Y188C, Y188H, Y188L, G190A, G190S, H221Y, L234I, 
M230I, M230L, P225H, F227C, F227L, F227V.

The following de novo resistance was seen in the resistance analysis subset (subjects with HIV-1 RNA 
greater than 400 copies per mL at virologic failure or early study discontinuation and having resistance 
data).

Table 3: Resistance development up to week 96 in protocol defined virologic failure population + 
early discontinuation population

DRIVE-FORWARD DRIVE-AHEAD
DOR + 
NRTIs*
(383)

DRV + r +
NRTIs*
(383)

DOR/TDF/3TC
(364)

EFV/TDF/FTC 
(364)

Successful genotype, n 15 18 32 33

Genotypic resistance to

DOR or control (DRV or EFV) 2 (DOR) 0 (DRV) 8 (DOR) 14 (EFV)

NRTI backbone 
M184I/V only
K65R only
K65R + M184I/V

2**

2
0
0

0
0
0
0

6
4
1
1

5
4
0
1

*NRTIs in DOR arm: FTC/TDF (333) or ABC/3TC (50); NRTIs in DRV+r arm: FTC/TDF (335) or ABC/3TC (48)
**Subjects received FTC/TDF
ABC=abacavir; FTC=emtricitabine; DRV=darunavir; r=ritonavir

Emergent doravirine associated resistance substitutions in RT included one or more of the following: 
A98G, V106I, V106A, V106M/T, Y188L, H221Y, P225H, F227C, F227C/R, and Y318Y/F.

Virologically suppressed adult subjects
The DRIVE-SHIFT study included virologically suppressed patients (N=670) with no history of 
treatment failure (see section, Clinical experience). A documented absence of genotypic resistance 
(prior to starting first therapy) to doravirine, lamivudine, and tenofovir was part of the inclusion 
criteria for patients who switched from a PI- or INI-based regimen.  Exclusionary NNRTI 
substitutions were those listed above (DRIVE-FORWARD and DRIVE-AHEAD), with the exception 
of substitutions RT K103N, G190A and Y181C (accepted in DRIVE-SHIFT). Documentation of pre-
treatment resistance genotyping was not required for patients who switched from a NNRTI-based 
regimen.

In the DRIVE-SHIFT clinical trial, no subjects developed genotypic or phenotypic resistance to DOR, 
3TC, or TDF during the initial 48 weeks (immediate switch, N=447) or 24 weeks (delayed switch, 
N=209) of treatment with DOR/3TC/TDF.  One subject developed RT M184M/I mutation and 
phenotypic resistance to 3TC and FTC during treatment with their baseline regimen.  None of the 
24 subjects (11 in the immediate switch group, 13 in the delayed switch group) with baseline NNRTI 
mutations (RT K103N, G190A, or Y181C) experienced virologic failure through Week 48, or at time 
of discontinuation.

Cross-resistance
Doravirine has been evaluated in a limited number of patients with NNRTI resistance (K103N n=7, 
G190A n=1); all patients were suppressed to < 40 copies/mL at week 48. A breakpoint for a reduction 

 



17

in susceptibility, yielded by various NNRTI substitutions, that is associated with a reduction in clinical 
efficacy has not been established.

Laboratory strains of HIV-1 harbouring the common NNRTI-associated mutations K103N, Y181C, or 
K103N/Y181C substitutions in RT exhibit less than a 3-fold decrease in susceptibility to doravirine 
compared to wild-type virus when evaluated in the presence of 100 % normal human serum. In in vitro
studies, doravirine was able to suppress the following NNRTI-associated substitutions; K103N, 
Y181C, and G190A under clinically relevant concentrations.

A panel of 96 diverse clinical isolates containing NNRTI-associated mutations was evaluated for 
susceptibility to doravirine in the presence of 10 % foetal bovine serum. Clinical isolates containing 
the Y188L substitution or V106 substitutions in combination with A98G, H221Y, P225H, F227C or 
Y318F showed a greater than 100-fold reduced susceptibility to doravirine. Other established NNRTI 
substitutions yielded a fold change of 5-10 (G190S (5.7), K103N/P225H (7.9), V108I/Y181C (6.9), 
Y181V (5.1)). The clinical relevance of a 5-10 fold reduction in susceptibility is unknown.

Treatment emergent doravirine resistance associated substitutions may confer cross resistance to 
efavirenz, rilpivirine, nevirapine, and etravirine. Of the 7 subjects who developed high level doravirine 
resistance in the pivotal studies, 6 had phenotypic resistance to EFV and nevirapine, 3 to rilpivirine, 
and 2 had partial resistance to etravirine based on the Monogram Phenosense assay.

Clinical experience

Treatment-naïve adult subjects
The efficacy of doravirine is based on the analyses of 96-week data from two randomised, multicentre, 
double-blind, active controlled Phase 3 trials, (DRIVE-FORWARD and DRIVE-AHEAD) in 
antiretroviral treatment-naïve, HIV-1 infected subjects (n = 1494). Refer to Resistance section for 
NNRTI substitutions that were part of exclusion criteria.

In DRIVE-FORWARD, 766 subjects were randomised and received at least 1 dose of either
doravirine 100 mg or darunavir + ritonavir 800+100 mg once daily, each in combination with 
emtricitabine/tenofovir disoproxil (FTC/TDF) or abacavir/lamivudine (ABC/3TC) selected by the 
investigator. At baseline, the median age of subjects was 33 years (range 18 to 69 years), 86 % had 
CD4+ T cell count greater than 200 cells per mm3, 84 % were male, 27 % were non-white, 4 % had 
hepatitis B and/or C virus co-infection, 10 % had a history of AIDS, 20 % had HIV-1 RNA greater 
than 100,000 copies per mL, 13 % received ABC/3TC and 87 % received FTC/TDF; these 
characteristics were similar between treatment groups.

In DRIVE-AHEAD, 728 subjects were randomized and received at least 1 dose of either 
doravirine/lamivudine/tenofovir disoproxil 100/300/245 mg (DOR/3TC/TDF) or 
efavirenz/emtricitabine/tenofovir disoproxil (EFV/FTC/TDF) once daily. At baseline, the median age 
of subjects was 31 years (range 18-70 years), 85 % were male, 52 % were non-white, 3% had hepatitis 
B or C co-infection, 14 % had a history of AIDS, 21 % had HIV-1 RNA > 100,000 copies per mL, and 
12 % had CD4+ T cell count < 200 cells per mm3; these characteristics were similar between treatment 
groups.

Week 48 and 96 outcomes for DRIVE-FORWARD and DRIVE-AHEAD are provided in Table 4. The 
doravirine-based regimens demonstrated consistent efficacy across demographic and baseline 
prognostic factors.

 



18

Table 4: Efficacy response (< 40 copies/mL, Snapshot approach) in the pivotal studies

DRIVE-FORWARD DRIVE-AHEAD

DOR + 2 NRTIs 

(383)

DRV + r + 2 

NRTIs (383)

DOR/3TC/TDF

(364)

EFV/FTC/TDF

(364)

Week 48 83 % 79 % 84 % 80 %

Difference (95 % CI) 4.2 % (-1.4%, 9.7 %) 4.1 % (-1.5 %, 9.7 %)

Week 96* 72 % (N=379) 64 % (N=376) 76 % (N=364) 73 % (N=364)

Difference (95 % CI) 7.6 % (1.0 %, 14.2 %) 3.3 % (-3.1 %, 9.6 %)

Week 48 outcome (< 40 copies/mL) by baseline factors

HIV-1 RNA copies/mL

≤ 100,000 256/285 (90 %) 248/282 (88 %) 251/277 (91 %) 234/258 (91 %)

> 100,000  63/79 (80 %) 54/72 (75 %) 54/69 (78 %) 56/73 (77 %)

CD4 count, cells/µL

≤ 200 34/41 (83 %) 43/61 (70 %) 27/42 (64 %) 35/43 (81 %)

> 200 285/323 (88 %) 260/294 (88 %) 278/304 (91 %) 255/288 (89 %)

NRTI background therapy   

TDF/FTC 276/316 (87 %) 267/312 (86 %)
NA

ABC/3TC 43/48 (90 %) 36/43 (84 %)

Viral subtype    

B 222/254 (87 %) 219/255 (86 %) 194/222 (87 %) 199/226 (88 %)

non-B 97/110 (88 %) 84/100 (84 %) 109/122 (89 %) 91/105 (87 %)

Mean CD4 change from baseline

Week 48 193 186 198 188

Week 96 224 207 238 223

*For Week 96, certain subjects with missing HIV-1 RNA were excluded from the analysis.

P007 was a Phase 2b trial in antiretroviral treatment-naïve HIV-1 infected adult subjects (n = 340). In 
Part I, subjects were randomized to receive one of 4 doses of doravirine or EFV, each in combination 
with FTC/TDF. After week 24, all subjects randomized to receive doravirine were switched to (or 
maintained on) doravirine 100 mg. Additional subjects were randomized in Part II to receive either 
doravirine 100 mg or EFV, each in combination with FTC/TDF. In both parts of the trial, doravirine 
and EFV were administered as blinded-therapy and FTC/TDF was administered open-label.

 



19

Table 5: Efficacy response at week 24 (Snapshot approach)

Doravirine 
25 mg

(N=40)
n (%)

Doravirine 
50 mg

(N=43)
n (%)

Doravirine 
100 mg

(N=42)
n (%)

Doravirine 
200 mg

(N=41)
n (%)

Efavirenz 
600 mg

(N=42)
n (%)

HIV-1 RNA < 40 copies/mL 32 (80) 32 (74) 30 (71) 33 (80) 27 (64)
Treatment differences †

(95 % CI) ††
16 (-4, 34) 10 (-10, 

29)
6.6 (-13, 

26)
16 (-3, 34)

Mean CD4 change from 
baseline (cells/mm3) ** 

154 113 134 141 121

†A positive value favours doravirine over efavirenz.
††The 95 % CIs were calculated using Miettinen and Nurminen’s method with weights proportional to the size of each 

stratum (screening HBV-1 RNA > 100,000 copies/mL or ≤ 100,000 copies/mL.
**Approach to handle missing data: Observed Failure (OF) approach. Baseline CD4 cell count was carried forward for 

subjects who discontinued assigned therapy due to lack of efficacy. 
Note: Both doravirine and efavirenz were administered with emtricitabine/tenofovir disoproxil (FTC/TDF).

Virologically suppressed adult subjects
The efficacy of switching from a baseline regimen consisting of two nucleoside reverse transcriptase 
inhibitors in combination with a ritonavir- or cobicistat-boosted PI, or cobicistat-boosted elvitegravir, 
or an NNRTI to DOR/3TC/TDF was evaluated in a randomized, open-label trial (DRIVE-SHIFT), in 
virologically suppressed HIV-1 infected adults.  Subjects must have been virologically suppressed 
(HIV-1 RNA < 40 copies/mL) on their baseline regimen for at least 6 months prior to trial entry, with 
no history of virologic failure, and a documented absence of RT substitutions conferring resistance to 
doravirine, lamivudine and tenofovir (see section Resistance).  Subjects were randomized to either 
switch to DOR/3TC/TDF at baseline [N = 447, Immediate Switch Group (ISG)], or stay on their 
baseline regimen until Week 24, at which point they switched to DOR/3TC/TDF [N = 223, Delayed 
Switch Group (DSG)].  At baseline, the median age of subjects was 43 years, 16 % were female, 
and 24 % were non-white.

In the DRIVE-SHIFT trial, an immediate switch to DOR/3TC/TDF was demonstrated to be non-
inferior at Week 48 compared to continuation of the baseline regimen at Week 24 as assessed by the 
proportion of subjects with HIV-1 RNA < 40 copies/mL. Treatment results are shown in Table 6.
Consistent results were seen for the comparison at study Week 24 in each treatment group.

 



20

Table 6: Efficacy response (Snapshot approach) in the DRIVE-SHIFT study

Outcome

DOR/3TC/TDF

Once Daily ISG 

Baseline Regimen 

DSG

Week 48 

N=447

Week 24 

N=223

HIV-1 RNA < 40 copies/mL 90 % 93 %

   ISG-DSG, Difference (95 % CI)* -3.6 % (-8.0 %, 0.9 %)

Proportion (%) of Subjects With HIV-1 RNA < 40 copies/mL by Baseline Regimen Received

Ritonavir- or Cobicistat-boosted PI 280/316 (89 %) 145/156 (93 %)

Cobicistat-boosted elvitegravir  23/25 (92 %) 11/12 (92 %)

NNRTI  98/106 (92 %) 52/55 (95 %)

Proportion (%) of Subjects With HIV-1 RNA < 40 copies/mL by Baseline CD4+ T cell Count 

(cells/mm3) 

     < 200 cells/mm3 10/13 (77 %)                3/4 (75 %)                                       

     ≥ 200 cells/mm3 384/426 (90 %)                                   202/216 (94 %)                                   

HIV-1 RNA ≥ 40 copies/mL† 3 %      4 %                                   

No Virologic Data Within the Time Window       8 % 3 %

  Discontinued study due to AE or Death‡                                                                                                                             3 %                                        0                        

   Discontinued study for Other Reasons§                                                                                                                             4 %   3 %                                 

   On study but missing data in window                                                                                               0                                                   0                                               

*The 95 % CI for the treatment difference was calculated using stratum-adjusted Mantel-Haenszel method. 

†Includes subjects who discontinued study drug or study before Week 48 for ISG or before Week 24 for DSG for lack 

or loss of efficacy and subjects with HIV-1 RNA ≥ 40 copies/mL in the Week 48 window for ISG and in the 

Week 24 window for DSG.

‡Includes subjects who discontinued because of adverse event (AE) or death if this resulted in no virologic data on 

treatment during the specified window.

§Other reasons include: lost to follow-up, non-compliance with study drug, physician decision, protocol deviation, 

withdrawal by subject.

Baseline Regimen = ritonavir or cobicistat-boosted PI (specifically atazanavir, darunavir, or lopinavir), or

cobicistat-boosted elvitegravir, or NNRTI (specifically efavirenz, nevirapine, or rilpivirine), each

administered with two NRTIs.

Discontinuation due to adverse events
In a pooled analysis combining data from two treatment-naïve trials (P007 and DRIVE-AHEAD), a 
lower proportion of subjects who discontinued due to an adverse event by week 48 was seen for the 
combined doravirine (100 mg) treatment groups (2.8 %) compared with the combined EFV treatment 
group (6.1 %) (treatment difference -3.4 %, p-value 0.012).

Paediatric population
The European Medicines Agency has deferred the obligation to submit the results of studies with
doravirine in one or more subsets of the paediatric population in treatment of human 
immunodeficiency virus-1 (HIV-1) infection, as per Paediatric Investigation Plan (PIP) decision in the 
granted indication. See section 4.2 for information on paediatric use.

 



21

5.2 Pharmacokinetic properties

Absorption
The pharmacokinetics of doravirine were studied in healthy subjects and HIV-1 infected subjects. 
Doravirine pharmacokinetics are similar in healthy subjects and HIV-1-infected subjects. Steady state 
was generally achieved by Day 2 of once daily dosing, with accumulation ratios of 1.2 to 1.4 for 
AUC0-24, Cmax, and C24. Doravirine steady state pharmacokinetics following administration of 100 mg 
once daily to HIV-1 infected subjects, based on a population pharmacokinetics analysis, are provided 
below.

Parameter
GM (% CV)

AUC0-24 
μM hr

Cmax
μM

C24
nM

Doravirine 
100 mg 
once daily

37.8 (29) 2.26 (19) 930 (63)

GM: Geometric mean, % CV: Geometric coefficient of variation

Following oral dosing, peak plasma concentrations are achieved 2 hours after dosing. Doravirine has 
an estimated absolute bioavailability of approximately 64 % for the 100 mg tablet.

Effect of food on oral absorption
The administration of a single doravirine tablet with a high-fat meal to healthy subjects resulted in a 
16 % and 36 % increase in doravirine AUC and C24, respectively, while Cmax was not significantly 
affected.

Distribution
Based on administration of an IV microdose, the volume of distribution of doravirine is 60.5 L. 
Doravirine is approximately 76 % bound to plasma proteins.

Biotransformation
Based on in vitro data, doravirine is primarily metabolized by CYP3A.

Elimination
Doravirine has a terminal half-life (t1/2) of approximately 15 hours. Doravirine is primarily eliminated 
via oxidative metabolism mediated by CYP3A4. Biliary excretion of unchanged medicinal product
may contribute to the elimination of doravirine, but this elimination route is not expected to be 
significant. Excretion of unchanged medicinal product via urinary excretion is minor.

Renal impairment
Renal excretion of doravirine is minor. In a study comparing 8 subjects with severe renal impairment 
to 8 subjects without renal impairment, the single dose exposure of doravirine was 31 % higher in 
subjects with severe renal impairment. In a population pharmacokinetic analysis, which included 
subjects with CrCl between 17 and 317 mL/min, renal function did not have a clinically relevant effect 
on doravirine pharmacokinetics. No dose adjustment is required in patients with mild, moderate or 
severe renal impairment. Doravirine has not been studied in patients with end-stage renal disease or in 
patients undergoing dialysis (see section 4.2).

Hepatic impairment
Doravirine is primarily metabolized and eliminated by the liver. There was no clinically relevant
difference in the pharmacokinetics of doravirine in a study comparing 8 subjects with moderate 
hepatic impairment (classified as Child-Pugh score B primarily due to increased encephalopathy and 
ascites scores) to 8 subjects without hepatic impairment. No dose adjustment is required in patients 
with mild or moderate hepatic impairment. Doravirine has not been studied in subjects with severe 
hepatic impairment (Child-Pugh score C) (see section 4.2).

 



22

Elderly
Although a limited number of subjects aged 65 years and over has been included (n=36), no clinically 
relevant differences in the pharmacokinetics of doravirine have been identified in subjects at least 
65 years of age compared to subjects less than 65 years of age in a Phase 1 trial or in a population 
pharmacokinetic analysis. No dose adjustment is required.

Gender
No clinically relevant pharmacokinetic differences have been identified between men and women for 
doravirine.

Race
No clinically relevant racial differences in the pharmacokinetics of doravirine have been identified 
based on a population pharmacokinetic analysis of doravirine in healthy and HIV-1 infected subjects.

5.3 Preclinical safety data

Reproductive toxicity
Reproduction studies with orally administered doravirine have been performed in rats and rabbits at 
exposures approximately 9 times (rats) and 8 times (rabbits) the exposure in humans at the 
recommended human dose (RHD) with no effects on embryo-foetal (rats and rabbits) or pre/postnatal 
(rats) development. Studies in pregnant rats and rabbits showed that doravirine is transferred to the 
foetus through the placenta, with foetal plasma concentrations of up to 40 % (rabbits) and 52 % (rats) 
that of maternal concentrations observed on gestation Day 20.

Doravirine was excreted into the milk of lactating rats following oral administration, with milk 
concentrations approximately 1.5 times that of maternal plasma concentrations.

Carcinogenesis
Long-term oral carcinogenicity studies of doravirine in mice and rats showed no evidence of 
carcinogenic potential at estimated exposures up to 6 times (mice) and 7 times (rats) the human 
exposures at the RHD.

Mutagenesis
Doravirine was not genotoxic in a battery of in vitro or in vivo assays.

Impairment of fertility
There were no effects on fertility, mating performance or early embryonic development when 
doravirine was administered to rats up to 7 times the exposure in humans at the RHD.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Tablet core
Croscarmellose sodium (E468)
Hypromellose acetate succinate
Lactose monohydrate
Magnesium stearate (E470b)
Microcrystalline cellulose (E460)
Silica, colloidal anhydrous (E551)

Film-coating
Carnauba wax (E903)
Hypromellose (E464)
Lactose monohydrate
Titanium dioxide (E171)

 



23

Triacetin (E1518)

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

30 months
After first opening of the bottle use within 35 days.

6.4 Special precautions for storage

Store in the original bottle and keep the bottle tightly closed in order to protect from moisture. Do not 
remove the desiccant. This medicinal product does not require any special temperature storage 
conditions. For storage conditions after first opening of the bottle see section 6.3.

6.5 Nature and contents of container

Each carton contains a high density polyethylene (HDPE) bottle with a polypropylene child-resistant 
closure with silica gel desiccant.

The following pack sizes are available:

 1 bottle with 30 film-coated tablets.
 90 film-coated tablets (3 bottles of 30 film-coated tablets).

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements.

7. MARKETING AUTHORISATION HOLDER

Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands

8. MARKETING AUTHORISATION NUMBER(S)

EU/1/18/1332/001
EU/1/18/1332/002

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 22 November 2018

10. DATE OF REVISION OF THE TEXT

Detailed information on this medicinal product is available on the website of the European Medicines
Agency http://www.ema.europa.eu.

 



24

ANNEX II

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH 
RELEASE

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY 
AND USE

C. OTHER CONDITIONS AND REQUIREMENTS OF THE 
MARKETING AUTHORISATION

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO 
THE SAFE AND EFFECTIVE USE OF THE MEDICINAL 
PRODUCT

 



25

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer(s) responsible for batch release
Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
NETHERLANDS

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product 
Characteristics, section 4.2).

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 
AUTHORISATION 

 Periodic safety update reports (PSURs)

The requirements for submission of PSURs for this medicinal product are set out in the list of Union 
reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any 
subsequent updates published on the European medicines web-portal.

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 
EFFECTIVE USE OF THE MEDICINAL PRODUCT

 Risk management plan (RMP)

The marketing authorization holder (MAH) shall perform the required pharmacovigilance activities 
and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing 
Authorisation and any agreed subsequent updates of the RMP.

An updated RMP should be submitted:

 At the request of the European Medicines Agency;

 Whenever the risk management system is modified, especially as the result of new 
information being received that may lead to a significant change to the benefit/risk profile or as the 
result of an important (pharmacovigilance or risk minimisation) milestone being reached. 

 



26

ANNEX III

LABELLING AND PACKAGE LEAFLET

 



27

A. LABELLING

 



28

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Outer carton 

1. NAME OF THE MEDICINAL PRODUCT

Pifeltro 100 mg film-coated tablets
doravirine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 100 mg of doravirine.

3. LIST OF EXCIPIENTS

Contains lactose.
See package leaflet for further information

4. PHARMACEUTICAL FORM AND CONTENTS

Film-coated tablets
30 film-coated tablets
90 (3 bottles of 30) film-coated tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.
Oral use. Swallow whole.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Keep the bottle tightly closed in order to protect from moisture.

 



29

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

Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/18/1332/001
EU/1/18/1332/002 90 (3 x 30) tablets

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Pifeltro

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC
SN
NN

 



30

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

Bottle label

1. NAME OF THE MEDICINAL PRODUCT

Pifeltro 100 mg film-coated tablets
doravirine

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet contains 100 mg of doravirine.

3. LIST OF EXCIPIENTS

Contains lactose.
See package leaflet for further information

4. PHARMACEUTICAL FORM AND CONTENTS

30 film-coated tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.
Oral use

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Keep the bottle tightly closed in order to protect from moisture.

 



31

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

Merck Sharp & Dohme B.V.

12. MARKETING AUTHORISATION NUMBER(S) 

EU/1/18/1332/001
EU/1/18/1332/002 90 (3 x 30) tablets

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

17. UNIQUE IDENTIFIER – 2D BARCODE

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

 



32

B. PACKAGE LEAFLET

 



33

Package leaflet: Information for the user
Pifeltro 100 mg film-coated tablets

doravirine

This medicine is subject to additional monitoring. This will allow quick identification of new 
safety information. You can help by reporting any side effects you may get. See the end of section 4
for how to report side effects.

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

even if their signs of illness are the same as yours.
 If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible 

side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Pifeltro is and what it is used for
2. What you need to know before you take Pifeltro
3. How to take Pifeltro
4. Possible side effects
5. How to store Pifeltro
6. Contents of the pack and other information

1. What Pifeltro is and what it is used for

What Pifeltro is
Pifeltro is used to treat HIV (‘human immunodeficiency virus’) infection. It belongs to a group of 
medicines called ‘antiretroviral medicines’.

Pifeltro contains the active substance doravirine - a non-nucleoside reverse transcriptase inhibitor 
(NNRTI).

What Pifeltro is used for
Pifeltro is used to treat HIV infection in people 18 years of age and older. HIV is the virus that causes 
AIDS (‘acquired immune deficiency syndrome’). You should not take Pifeltro if your doctor has told 
you that the virus causing your infection is resistant to doravirine.

Pifeltro must be used in combination with other medicines for HIV.

How Pifeltro works
When used with other medicines, Pifeltro works by preventing HIV from making more viruses in your 
body. This will help by:
 reducing the amount of HIV in your blood (this is called your ‘viral load’)
 increasing the number of white blood cells called ‘CD4+ T’. This can make your immune 

system stronger. This may reduce your risk of early death or catching infections because your 
immune system is weak.

 



34

2. What you need to know before you take Pifeltro

Do not take Pifeltro:

 if you are allergic to doravirine or any of the other ingredients of this medicine listed in 
section 6.

 if you are taking the following medicines:
 carbamazepine, oxcarbazepine, phenobarbital, phenytoin (medicines for seizures)
 rifampicin, rifapentine (medicines for tuberculosis)
St. John’s wort (Hypericum perforatum, a herbal remedy used for depression and anxiety) or 

products that contain it
mitotane (a medicine to treat cancer)
 enzalutamide (a medicine to treat prostate cancer)
 lumacaftor (a medicine to treat cystic fibrosis)

Do not take Pifeltro if the above applies to you. If you are not sure, talk to your doctor, pharmacist, or 
nurse before taking Pifeltro. See also “Other Medicines and Pifeltro” section.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Pifeltro.

Passing HIV to others
HIV is spread by contact with blood or through sexual contact with a person with HIV. You can still
pass on HIV when taking Pifeltro, although effective therapy lowers the risk. Talk to your doctor 
about what you can do to avoid infecting other people.

Immune reactivation syndrome
This can happen when you start taking any HIV medicine, including this medicine. Your immune 
system may get stronger and begin to fight infections that have been hidden in your body for a long 
time. Tell your doctor right away if you start having any new symptoms after starting your HIV
medicine.

Autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) 
may also occur after you start taking medicines for the treatment of your HIV infection. Autoimmune 
disorders may occur many months after the start of treatment. If you notice any symptoms of infection 
or other symptoms such as muscle weakness, weakness beginning in the hands and feet and moving up 
towards the trunk of the body, palpitations, tremor or hyperactivity, please inform your doctor 
immediately to seek necessary treatment.

Children and adolescents
Do not give this medicine to anybody aged less than 18 years. The use of Pifeltro in people aged 
less than 18 years has not yet been studied.

Other medicines and Pifeltro
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken or might take any other 
medicines. This is because other medicines may affect how Pifeltro works, and Pifeltro might affect 
the way some other medicines work.

There are some medicines you must not take with Pifeltro. See list under “Do not take Pifeltro” 
section.

Talk to your doctor before taking the following medicines with Pifeltro, as your doctor may need to 
change the dose of your medicines:

 bosentan (a medicine to treat lung disease)
 dabrafenib (a medicine to treat skin cancer)

 



35

 lesinurad (a medicine to treat gout)
 modafinil (a medicine to treat excessive sleepiness)
 nafcillin (a medicine to treat some bacterial infections)
 rifabutin (a medicine to treat some bacterial infections such as tuberculosis)
 telotristat ethyl (a medicine to treat diarrhoea in people with carcinoid syndrome)
 thioridazine (a medicine to treat psychiatric conditions such as schizophrenia)

If your doctor decides you should take these medicines with Pifeltro, one tablet of doravirine should be 
taken twice daily (approximately 12 hours apart).

Your doctor may check your blood levels or monitor for side effects if you take the following 
medicines with Pifeltro:
 sirolimus (a medicine used to control your body’s immune response after a transplant)
 tacrolimus (a medicine used to control your body’s immune response after a transplant)

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, talk 
to your doctor about the risks and benefits of taking Pifeltro. It is preferable to avoid the use of this 
medicine during pregnancy. This is because it has not been studied in pregnancy and it is not known if 
it will harm your baby while you are pregnant.

Women with HIV should not breast-feed because HIV can be passed on to their babies through breast 
milk. Talk with your doctor about the best way to feed your baby.

Driving and using machines
Use caution when driving or riding a bicycle, or operating machines if you feel dizzy, tired, or sleepy 
after taking this medicine.

Pifeltro tablets contain lactose
If you have been told by your doctor that you have an intolerance to lactose, talk to your doctor before 
taking this medicine.

3. How to take Pifeltro

Always take this medicine exactly as your doctor, pharmacist, or nurse has told you. Check with your 
doctor, pharmacist, or nurse if you are not sure. This medicine must be used in combination with other 
medicines for HIV.

How much to take
The recommended dose is 1 tablet once a day. If you take certain medicines, your doctor may need to 
change the amount of doravirine you take. See “Other medicines and Pifeltro” section for a list of 
medicines.

Taking this medicine
 Swallow the tablet whole (do not crush or chew).
 This medicine can be taken with food or between meals.

If you take more Pifeltro than you should
Do not take more than the recommended dose. If you accidentally take more, contact your doctor.

If you forget to take Pifeltro
 It is important that you do not miss or skip doses of this medicine.
 If you forget to take a dose, take it as soon as you remember. But if your next dose is due within 

12 hours, skip the dose you missed and take the next one at the usual time. Then continue your 
treatment as before.

 



36

 Do not take a double dose to make up for a missed dose.
 If you are not sure what to do, call your doctor or pharmacist.

If you stop taking Pifeltro
Do not run out of this medicine. Refill your prescription or talk to your doctor before it is all gone.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Do not 
stop taking this medicine without first talking to your doctor.

Common: may affect up to 1 in 10 people:
 abnormal dreams, difficulty in sleeping (insomnia)
 headache, dizziness, sleepiness

 feeling sick (nausea), diarrhoea, stomach pain, vomiting, wind (flatulence)
 rash
 feeling tired

Blood tests may also show:
 increased levels of liver enzymes (ALT)

Uncommon: may affect up to 1 in 100 people:
 nightmares, depression, anxiety, irritability, confusion, suicidal thoughts
 trouble concentrating, memory problems, tingling of hands and feet, stiff muscles, poor quality 

sleep
 high blood pressure
 constipation, stomach discomfort, swollen or bloated stomach (abdominal distension), 

indigestion, soft stools, stomach spasms
 itchiness
 muscle pain, joint pain
 feeling weak, general feeling of being unwell

Blood tests may also show:
 decreased levels of phosphate
 increased levels of liver enzymes (AST)
 increased levels of lipase
 increased levels of amylase
 decreased levels of haemoglobin

Rare: may affect up to 1 in 1,000 people

 aggression, hallucinations, difficulty adjusting to changes, mood changes, sleep walking
 difficulty breathing, enlarged tonsils
 feeling of incomplete defecation
 inflammation of the skin due to allergy, redness on the cheeks, nose, chin or forehead, bumps or 

pimples on the face
 kidney damage, kidney problems, kidney stones
 pain in the chest, feeling cold, pain, thirst

Blood tests may also show:
 decreased levels of magnesium
 increased levels of creatine phosphokinase

 



37

Reporting of side effects
If you get any side effects, talk to your doctor,pharmacist, or nurse. This includes any possible side 
effects not listed in this leaflet. You can also report side effects directly via the national reporting 
system listed in Appendix V. By reporting side effects, you can help provide more information on the 
safety of this medicine.

5. How to store Pifeltro

 Keep this medicine out of the sight and reach of children.
 Do not use this medicine after the expiry date which is stated on the bottle after EXP. This 

medicine should be used within 35 days after first opening of the bottle.
 The bottle contains a desiccant protecting the tablets from moisture. Keep the desiccant inside 

the bottle and do not throw away until you have finished taking all of the medicine.
 Keep the bottle tightly closed in order to protect from moisture.
 This medicinal product does not require any special temperature storage conditions.
 Do not throw away any medicines via wastewater or household waste. Ask your pharmacist 

how to throw away medicines you no longer use. These measures will help protect the 
environment.

6. Contents of the pack and other information

What Pifeltro contains
 The active substance is doravirine 100 mg.

 The other ingredients are croscarmellose sodium E468; hypromellose acetate succinate; lactose 
monohydrate; magnesium stearate E470b; microcrystalline cellulose E460; and silica, colloidal 
anhydrous E551. The tablets are film-coated with a coating material containing the following 
ingredients: carnauba wax E903; hypromellose E464; lactose monohydrate; titanium dioxide 
E171; and triacetin E1518.

What Pifeltro looks like and contents of the pack
Pifeltro is available as a white, oval-shaped, film-coated tablet, and is debossed with the corporate 
logo and 700 on one side and plain on the other side.

The following pack sizes are available:
 1 bottle with 30 film-coated tablets
 90 film-coated tablets (3 bottles of 30 film-coated tablets)

Not all pack sizes may be available in your country.

Marketing Authorisation Holder and Manufacturer
Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands

For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder:

België/Belgique/Belgien
MSD Belgium BVBA/SPRL
Tél/Tel: +32(0)27766211
dpoc_belux@merck.com

Lietuva
UAB Merck Sharp & Dohme
Tel. + 370 5 278 02 47
msd_lietuva@merck.com

България Luxembourg/Luxemburg

 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


38

Мерк Шарп и Доум България ЕООД
Тел.: +359 2 819 3737
info-msdbg@merck.com

MSD Belgium BVBA/SPRL
Tél/Tel: +32(0)27766211
dpoc_belux@merck.com

Česká republika
Merck Sharp & Dohme s.r.o.
Tel: +420 233 010 111 
dpoc_czechslovak@merck.com

Magyarország
MSD Pharma Hungary Kft. 
Tel.: +36 1 888 5300
hungary_msd@merck.com

Danmark
MSD Danmark ApS
Tlf: + 45 4482 4000
dkmail@merck.com

Malta
Merck Sharp & Dohme Cyprus Limited
Tel: 8007 4433 (+356 99917558)
malta_info@merck.com

Deutschland
MSD SHARP & DOHME GMBH
Tel: 0800 673 673 673 (+49 (0) 89 4561 2612)
e-mail@msd.de

Nederland
Merck Sharp & Dohme B.V.
Tel: 0800 9999000 
(+31 23 5153153)
medicalinfo.nl@merck.com

Eesti
Merck Sharp & Dohme OÜ
Tel.: +372 6144 200
msdeesti@merck.com

Norge
MSD (Norge) AS
Tlf: +47 32 20 73 00
msdnorge@msd.no

Ελλάδα
MSD Α.Φ.Β.Ε.Ε.
Τηλ: +30 210 98 97 300
dpoc_greece@merck.com

Österreich
Merck Sharp & Dohme Ges.m.b.H.
Tel: +43 (0) 1 26 044
msd-medizin@merck.com

España
Merck Sharp & Dohme de España, S.A.
Tel: +34 91 321 06 00
msd_info@merck.com

Polska
MSD Polska Sp. z o.o.
Tel: +48 22 549 51 00
msdpolska@merck.com

France
MSD France
Tél: + 33 (0) 1 80 46 40 40

Portugal
Merck Sharp & Dohme, Lda
Tel: +351 21 4465700
inform_pt@merck.com

Hrvatska:
Merck Sharp & Dohme d.o.o. 
Tel: + 385 1 6611 333
croatia_info@merck.com

România
Merck Sharp & Dohme Romania S.R.L.
Tel: +40 21 529 29 00
msdromania@merck.com

Ireland
Merck Sharp & Dohme Ireland (Human Health) 
Limited
Tel: +353 (0)1 2998700
medinfo_ireland@merck.com

Slovenija
Merck Sharp & Dohme, inovativna zdravila d.o.o.
Tel: +386 1 5204 201
msd.slovenia@merck.com

Ísland
Vistor hf.
Sími: + 354 535 7000

Slovenská republika
Merck Sharp & Dohme, s. r. o.
Tel: +421 2 58282010
dpoc_czechslovak@merck.com

 

mailto:msd.slovenia@merck.com
mailto:croatia_info@merck.com
mailto:msdpolska@merck.com
mailto:msd_info@merck.com


39

Italia
MSD Italia S.r.l. 
Tel: +39 06 361911
medicalinformation.it@merck.com

Suomi/Finland
MSD Finland Oy
Puh/Tel: +358 (0)9 804 650
info@msd.fi

Κύπρος
Merck Sharp & Dohme Cyprus Limited
Τηλ.: 800 00 673 (+357 22866700)
cyprus_info@merck.com

Sverige
Merck Sharp & Dohme (Sweden) AB
Tel: +46 77 5700488
medicinskinfo@merck.com

Latvija
SIA Merck Sharp & Dohme Latvija
Tel: + 371 67364224
msd_lv@merck.com

United Kingdom
Merck Sharp & Dohme Limited
Tel: +44 (0) 1992 467272
medicalinformationuk@merck.com

This leaflet was last revised in {MM/YYYY}

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu .

 

mailto:cyprus_info@merck.com
mailto:medicalinformation.it@merck.com

	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET
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{'Title': '2. what you need to know before you take pifeltro', 'Section_Content': 'do not take pifeltro: if you are allergic to doravirine or any of the other ingredients of this medicine listed in section 6. if you are taking the following medicines: carbamazepine, oxcarbazepine, phenobarbital, phenytoin (medicines for seizures) rifampicin, rifapentine (medicines for tuberculosis) st. john\'s wort (hypericum perforatum, a herbal remedy used for depression and anxiety) or products that contain it mitotane (a medicine to treat cancer) enzalutamide (a medicine to treat prostate cancer) lumacaftor (a medicine to treat cystic fibrosis) do not take pifeltro if the above applies to you. if you are not sure, talk to your doctor, pharmacist, or nurse before taking pifeltro. see also "other medicines and pifeltro" section. warnings and precautions talk to your doctor, pharmacist, or nurse before taking pifeltro. passing hiv to others hiv is spread by contact with blood or through sexual contact with a person with hiv. you can still pass on hiv when taking pifeltro, although effective therapy lowers the risk. talk to your doctor about what you can do to avoid infecting other people. immune reactivation syndrome this can happen when you start taking any hiv medicine, including this medicine. your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. tell your doctor right away if you start having any new symptoms after starting your hiv medicine. autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your hiv infection. autoimmune disorders may occur many months after the start of treatment. if you notice any symptoms of infection or other symptoms such as muscle weakness, weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity, please inform your doctor immediately to seek necessary treatment. children and adolescents do not give this medicine to anybody aged less than 18 years. the use of pifeltro in people aged less than 18 years has not yet been studied. other medicines and pifeltro tell your doctor, pharmacist, or nurse if you are taking, have recently taken or might take any other medicines. this is because other medicines may affect how pifeltro works, and pifeltro might affect the way some other medicines work. there are some medicines you must not take with pifeltro. see list under "do not take pifeltro" section. talk to your doctor before taking the following medicines with pifeltro, as your doctor may need to change the dose of your medicines: bosentan (a medicine to treat lung disease) dabrafenib (a medicine to treat skin cancer) 35 lesinurad (a medicine to treat gout) modafinil (a medicine to treat excessive sleepiness) nafcillin (a medicine to treat some bacterial infections) rifabutin (a medicine to treat some bacterial infections such as tuberculosis) telotristat ethyl (a medicine to treat diarrhoea in people with carcinoid syndrome) thioridazine (a medicine to treat psychiatric conditions such as schizophrenia) if your doctor decides you should take these medicines with pifeltro, one tablet of doravirine should be taken twice daily (approximately 12 hours apart). your doctor may check your blood levels or monitor for side effects if you take the following medicines with pifeltro: sirolimus (a medicine used to control your body\'s immune response after a transplant) tacrolimus (a medicine used to control your body\'s immune response after a transplant) pregnancy and breast-feeding if you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, talk to your doctor about the risks and benefits of taking pifeltro. it is preferable to avoid the use of this medicine during pregnancy. this is because it has not been studied in pregnancy and it is not known 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{'Title': '3. how to take pifeltro', 'Section_Content': 'always take this medicine exactly as your doctor, pharmacist, or nurse has told you. check with your doctor, pharmacist, or nurse if you are not sure. this medicine must be used in combination with other medicines for hiv. how much to take the recommended dose is 1 tablet once a day. if you take certain medicines, your doctor may need to change the amount of doravirine you take. see "other medicines and pifeltro" section for a list of medicines. taking this medicine swallow the tablet whole (do not crush or chew). this medicine can be taken with food or between meals. if you take more pifeltro than you should do not take more than the recommended dose. if you accidentally take more, contact your doctor. if you forget to take pifeltro it is important that you do not miss or skip doses of this medicine. if you forget to take a dose, take it as soon as you remember. but if your next dose is due within 12 hours, skip the dose you missed and take the next one at the usual time. then continue your treatment as before. do not take a double dose to make up for a missed dose. if you are not sure what to do, call your doctor or pharmacist. if you stop taking pifeltro do not run out of this medicine. refill your prescription or talk to your doctor before it is all gone. if you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.', 'Entity_Recognition': [{'Text': 'pifeltro', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 151, 'EndOffset': 164}, {'Text': 'other medicines', 'Type': 'TREATMENT', 'BeginOffset': 198, 'EndOffset': 213}, {'Id': 7, 'BeginOffset': 218, 'EndOffset': 221, 'Score': 0.6609531044960022, 'Text': 'hiv', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'DIAGNOSIS', 'Score': 0.6595960259437561}]}, {'Text': '1', 'Type': 'NUMBER', 'BeginOffset': 264, 'EndOffset': 265}, {'Text': 'certain medicines', 'Type': 'TREATMENT', 'BeginOffset': 297, 'EndOffset': 314}, {'Id': 2, 'BeginOffset': 361, 'EndOffset': 371, 'Score': 0.9945979118347168, 'Text': 'doravirine', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Id': 3, 'BeginOffset': 407, 'EndOffset': 415, 'Score': 0.5553513169288635, 'Text': 'pifeltro', 'Category': 'MEDICATION', 'Type': 'BRAND_NAME', 'Traits': []}, {'Text': 'medicines', 'Type': 'TREATMENT', 'BeginOffset': 439, 'EndOffset': 448}, {'Text': 'this medicine swallow', 'Type': 'TREATMENT', 'BeginOffset': 457, 'EndOffset': 478}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 520, 'EndOffset': 533}, {'Id': 4, 'BeginOffset': 592, 'EndOffset': 600, 'Score': 0.30842021107673645, 'Text': 'pifeltro', 'Category': 'MEDICATION', 'Type': 'BRAND_NAME', 'Traits': []}, {'Id': 5, 'BeginOffset': 735, 'EndOffset': 743, 'Score': 0.5593210458755493, 'Text': 'pifeltro', 'Category': 'MEDICATION', 'Type': 'BRAND_NAME', 'Traits': []}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 798, 'EndOffset': 811}, {'Text': '12', 'Type': 'NUMBER', 'BeginOffset': 912, 'EndOffset': 914}, {'Text': 'your treatment', 'Type': 'TREATMENT', 'BeginOffset': 1002, 'EndOffset': 1016}, {'Text': 'a double dose', 'Type': 'TREATMENT', 'BeginOffset': 1040, 'EndOffset': 1053}, {'Id': 6, 'BeginOffset': 1167, 'EndOffset': 1175, 'Score': 0.6153852343559265, 'Text': 'pifeltro', 'Category': 'MEDICATION', 'Type': 'BRAND_NAME', 'Traits': [{'Name': 'NEGATION', 'Score': 0.6588630676269531}]}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 1194, 'EndOffset': 1207}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 1328, 'EndOffset': 1341}]}
{'Title': '4. possible side effects', 'Section_Content': 'like all medicines, this medicine can cause side effects, although not everybody gets them. do not stop taking this medicine without first talking to your doctor. common: may affect up to 1 in 10 people: abnormal dreams, difficulty in sleeping (insomnia) headache, dizziness, sleepiness feeling sick (nausea), diarrhoea, stomach pain, vomiting, wind (flatulence) rash feeling tired blood tests may also show: increased levels of liver enzymes (alt) uncommon: may affect up to 1 in 100 people: nightmares, depression, anxiety, irritability, confusion, suicidal thoughts trouble concentrating, memory problems, tingling of hands and feet, stiff muscles, poor quality sleep high blood pressure constipation, stomach discomfort, swollen or bloated stomach (abdominal distension), indigestion, soft stools, stomach spasms itchiness muscle pain, joint pain feeling weak, general feeling of being unwell blood tests may also show: decreased levels of phosphate increased levels of liver enzymes (ast) increased levels of lipase increased levels of amylase decreased levels of haemoglobin rare: may affect up to 1 in 1,000 people aggression, hallucinations, difficulty adjusting to changes, mood changes, sleep walking difficulty breathing, enlarged tonsils feeling of incomplete defecation inflammation of the skin due to allergy, redness on the cheeks, nose, chin or forehead, bumps or pimples on the face kidney damage, kidney problems, kidney stones pain in the chest, feeling cold, pain, thirst blood tests may also show: decreased levels of magnesium increased levels of creatine phosphokinase 37 reporting of side effects if you get any side effects, talk to your doctor,pharmacist, or nurse. this includes any possible side effects not listed in this leaflet. you can also report side effects directly via the national reporting system listed in appendix v. by reporting side effects, you can help provide more information on the safety of 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{'Title': '5. how to store pifeltro', 'Section_Content': ' keep this medicine out of the sight and reach of children. do not use this medicine after the expiry date which is stated on the bottle after exp. this medicine should be used within 35 days after first opening of the bottle. the bottle contains a desiccant protecting the tablets from moisture. keep the desiccant inside the bottle and do not throw away until you have finished taking all of the medicine. keep the bottle tightly closed in order to protect from moisture. this medicinal product does not require any special temperature storage conditions. do not throw away any medicines via wastewater or household waste. ask your pharmacist how to throw away medicines you no longer use. these measures will help protect the environment.', 'Entity_Recognition': [{'Text': 'pifeltro', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 71, 'EndOffset': 84}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 148, 'EndOffset': 161}, {'Text': '35', 'Type': 'NUMBER', 'BeginOffset': 184, 'EndOffset': 186}, {'Text': 'the medicine', 'Type': 'TREATMENT', 'BeginOffset': 394, 'EndOffset': 406}, {'Text': 'the bottle', 'Type': 'TREATMENT', 'BeginOffset': 413, 'EndOffset': 423}]}
{'Title': '6. contents of the pack and other information', 'Section_Content': 'what pifeltro contains the active substance is doravirine 100 mg. the other ingredients are croscarmellose sodium e468; hypromellose acetate succinate; lactose monohydrate; magnesium stearate e470b; microcrystalline cellulose e460; and silica, colloidal anhydrous e551. the tablets are film-coated with a coating material containing the following ingredients: carnauba wax e903; hypromellose e464; lactose monohydrate; titanium dioxide e171; and triacetin e1518. what pifeltro looks like and contents of the pack pifeltro is available as a white, oval-shaped, film-coated tablet, and is debossed with the corporate logo and 700 on one side and plain on the other side. the following pack sizes are available: 1 bottle with 30 film-coated tablets 90 film-coated tablets (3 bottles of 30 film-coated tablets) not all pack sizes may be available in your country.', 'Entity_Recognition': [{'Text': 'pifeltro', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 0, 'BeginOffset': 47, 'EndOffset': 57, 'Score': 0.9963323473930359, 'Text': 'doravirine', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [], 'Attributes': [{'Type': 'DOSAGE', 'Score': 0.866254448890686, 'RelationshipScore': 0.9999996423721313, 'RelationshipType': 'DOSAGE', 'Id': 1, 'BeginOffset': 58, 'EndOffset': 65, 'Text': '100 mg.', 'Category': 'MEDICATION', 'Traits': []}]}, {'Text': '100', 'Type': 'NUMBER', 'BeginOffset': 58, 'EndOffset': 61}, {'Id': 2, 'BeginOffset': 92, 'EndOffset': 118, 'Score': 0.9231790900230408, 'Text': 'croscarmellose sodium e468', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Id': 3, 'BeginOffset': 120, 'EndOffset': 150, 'Score': 0.8940216898918152, 'Text': 'hypromellose acetate succinate', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Id': 4, 'BeginOffset': 152, 'EndOffset': 171, 'Score': 0.8137514591217041, 'Text': 'lactose monohydrate', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Id': 5, 'BeginOffset': 173, 'EndOffset': 191, 'Score': 0.9975728392601013, 'Text': 'magnesium stearate', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [], 'Attributes': [{'Type': 'STRENGTH', 'Score': 0.49982237815856934, 'RelationshipScore': 0.999923825263977, 'RelationshipType': 'STRENGTH', 'Id': 6, 'BeginOffset': 192, 'EndOffset': 197, 'Text': 'e470b', 'Category': 'MEDICATION', 'Traits': []}]}, {'Text': 'microcrystalline cellulose e', 'Type': 'TREATMENT', 'BeginOffset': 199, 'EndOffset': 227}, {'Text': 'silica, colloidal anhydrous', 'Type': 'TREATMENT', 'BeginOffset': 236, 'EndOffset': 263}, {'Text': 'the tablets are film', 'Type': 'TREATMENT', 'BeginOffset': 270, 'EndOffset': 290}, {'Text': 'a coating material', 'Type': 'TREATMENT', 'BeginOffset': 303, 'EndOffset': 321}, {'Text': 'carnauba wax', 'Type': 'TREATMENT', 'BeginOffset': 360, 'EndOffset': 372}, {'Text': 'hypromellose e', 'Type': 'TREATMENT', 'BeginOffset': 379, 'EndOffset': 393}, {'Id': 13, 'BeginOffset': 398, 'EndOffset': 417, 'Score': 0.8383169174194336, 'Text': 'lactose monohydrate', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Id': 14, 'BeginOffset': 419, 'EndOffset': 435, 'Score': 0.9979889392852783, 'Text': 'titanium dioxide', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Id': 15, 'BeginOffset': 446, 'EndOffset': 455, 'Score': 0.5308223366737366, 'Text': 'triacetin', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Id': 16, 'BeginOffset': 468, 'EndOffset': 476, 'Score': 0.26357701420783997, 'Text': 'pifeltro', 'Category': 'MEDICATION', 'Type': 'BRAND_NAME', 'Traits': []}, {'Text': 'the pack pifeltro', 'Type': 'TREATMENT', 'BeginOffset': 504, 'EndOffset': 521}, {'Text': 'film', 'Type': 'TEST', 'BeginOffset': 560, 'EndOffset': 564}, {'Text': '700', 'Type': 'NUMBER', 'BeginOffset': 624, 'EndOffset': 627}, {'Text': 'the following pack sizes', 'Type': 'TREATMENT', 'BeginOffset': 669, 'EndOffset': 693}, {'Text': '1', 'Type': 'NUMBER', 'BeginOffset': 709, 'EndOffset': 710}, {'Text': '30 film-coated tablets 90 film-coated tablets (3 bottles of 30 film-coated tablets', 'Type': 'TREATMENT', 'BeginOffset': 723, 'EndOffset': 805}, {'Text': '90', 'Type': 'NUMBER', 'BeginOffset': 746, 'EndOffset': 748}, {'Text': '30', 'Type': 'NUMBER', 'BeginOffset': 783, 'EndOffset': 785}, {'Text': 'all pack sizes', 'Type': 'TREATMENT', 'BeginOffset': 811, 'EndOffset': 825}]}