Lorviqua
1 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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 

 

Lorviqua 25 mg film-coated tablets 

Lorviqua 100 mg film-coated tablets 

 

 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

 

Lorviqua 25 mg film-coated tablets 

 

Each film-coated tablet contains 25 mg of lorlatinib. 

 

Excipient with known effect 

Each film-coated tablet contains 1.58 mg of lactose monohydrate. 

 

Lorviqua 100 mg film-coated tablets 

 

Each film-coated tablet contains 100 mg of lorlatinib. 

 

Excipient with known effect  

Each film-coated tablet contains 4.20 mg of lactose monohydrate. 

 

For the full list of excipients, see section 6.1. 

 

 

3. PHARMACEUTICAL FORM 

 

Film-coated tablet (tablet). 

 

Lorviqua 25 mg film-coated tablets 

 

Round (8 mm) light pink immediate release film-coated tablet, debossed with “Pfizer” on one side and 

“25” and “LLN” on the other side. 

 

Lorviqua 100 mg film-coated tablets 

 

Oval (8.5 × 17 mm) dark pink immediate release film-coated tablet, debossed with “Pfizer” on 

one side and “LLN 100” on the other side. 

 

 

4. CLINICAL PARTICULARS 

 

4.1 Therapeutic indications 

 

Lorviqua as monotherapy is indicated for the treatment of adult patients with anaplastic lymphoma 

kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) whose disease has progressed 

after: 

• alectinib or ceritinib as the first ALK tyrosine kinase inhibitor (TKI) therapy; or 

• crizotinib and at least one other ALK TKI.   

 



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4.2 Posology and method of administration 

 

Treatment with lorlatinib should be initiated and supervised by a physician experienced in the use of 

anticancer medicinal products. 

 

Posology 

 

The recommended dose is 100 mg lorlatinib taken orally once daily. 

 

Duration of treatment 

Treatment with lorlatinib is recommended as long as the patient is deriving clinical benefit from 

therapy without unacceptable toxicity. 

 

Delayed or missed doses 

If a dose of Lorviqua is missed, then it should be taken as soon as the patient remembers unless it is 

less than 4 hours before the next dose, in which case the patient should not take the missed dose. 

Patients should not take 2 doses at the same time to make up for a missed dose. 

 

Dose modifications 

Dosing interruption or dose reduction may be required based on individual safety and tolerability. 

Lorlatinib dose reduction levels are summarised below: 

• First dose reduction: 75 mg taken orally once daily 

• Second dose reduction: 50 mg taken orally once daily 

 

Lorlatinib should be permanently discontinued if the patient is unable to tolerate the 50 mg dose taken 

orally once daily. 

 

Dose modification recommendations for toxicities and for patients who develop atrioventricular (AV) 

block are provided in Table 1. 

 
Table 1. Recommended lorlatinib dose modifications for adverse reactions 

Adverse reactiona Lorlatinib dosing 

Hypercholesterolaemia or hypertriglyceridaemia  

Mild hypercholesterolaemia 

(cholesterol between ULN and 300 mg/dL 

or between ULN and 7.75 mmol/L) 

 

OR 

 

Moderate hypercholesterolaemia 

(cholesterol between 301 and 400 mg/dL 

or between 7.76 and 10.34 mmol/L) 

 

OR 

 

Mild hypertriglyceridaemia 

(triglycerides between 150 and 300 mg/dL 

or 1.71 and 3.42 mmol/L) 

OR  

 

Moderate hypertriglyceridaemia 

(triglycerides between 301 and 500 mg/dL 

or 3.43 and 5.7 mmol/L) 

Introduce or modify lipid-lowering therapyb in 

accordance with respective prescribing information; 

continue lorlatinib at same dose. 



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Table 1. Recommended lorlatinib dose modifications for adverse reactions 

Adverse reactiona Lorlatinib dosing 

Severe hypercholesterolaemia 

(cholesterol between 401 and 500 mg/dL 

or between 10.35 and 12.92 mmol/L) 

 

OR 

 

Severe hypertriglyceridaemia 

(triglycerides between 501 and 

1,000 mg/dL or 5.71 and 11.4 mmol/L) 

Introduce the use of lipid-lowering therapy b; if 

currently on lipid-lowering therapy, increase the dose 

of this therapyb in accordance with respective 

prescribing information; or change to a new 

lipid-lowering therapyb. Continue lorlatinib at the 

same dose without interruption.  

Life-threatening hypercholesterolaemia 

(cholesterol over 500 mg/dL or over 

12.92 mmol/L) 

 

OR 

 

Life-threatening hypertriglyceridaemia 

(triglycerides over 1,000 mg/dL or over 

11.4 mmol/L) 

Introduce the use of lipid-lowering therapyb or 

increase the dose of this therapyb in accordance with 

respective prescribing information or change to a new 

lipid-lowering therapyb. Withhold lorlatinib until 

recovery of hypercholesterolaemia and/or 

hypertriglyceridaemia to moderate or mild severity 

grade. 

 

Re-challenge at same lorlatinib dose while maximising 

lipid-lowering therapyb in accordance with respective 

prescribing information. 

 

If severe hypercholesterolaemia and/or 

hypertriglyceridaemia recur despite maximal 

lipid-lowering therapyb in accordance with respective 

prescribing information, reduce lorlatinib by 1 dose 

level. 

Central nervous system effects (comprises psychotic effects and changes in cognition, mood, 

mental status or speech) 

Grade 2: Moderate 

  

OR  

 

Grade 3: Severe  

Withhold dose until toxicity is less than or equal to 

Grade 1. Then resume lorlatinib at 1 reduced dose 

level.  

Grade 4: Life-threatening/Urgent 

intervention indicated 
Permanently discontinue lorlatinib. 

Lipase/Amylase increase  

Grade 3: Severe 

 

OR  

 

Grade 4: Life-threatening/Urgent 

intervention indicated 

Withhold lorlatinib until lipase or amylase returns to 

baseline. Then resume lorlatinib at 1 reduced dose 

level. 

Interstitial lung disease (ILD)/Pneumonitis  

Grade 1: Mild 

 

OR  

 

Grade 2: Moderate 

Withhold lorlatinib until symptoms have returned to 

baseline and consider initiating corticosteroids. 

Resume lorlatinib at 1 reduced dose level. 

 

Permanently discontinue lorlatinib if ILD/pneumonitis 

recurs or fails to recover after 6 weeks of lorlatinib 

hold and steroid treatment. 

Grade 3: Severe  

 

OR 

 

Grade 4: Life-threatening/Urgent 

Permanently discontinue lorlatinib. 



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Table 1. Recommended lorlatinib dose modifications for adverse reactions 

Adverse reactiona Lorlatinib dosing 

intervention indicated 

PR interval prolongation/Atrioventricular (AV) block 

First degree AV block: 

Asymptomatic  

Continue lorlatinib at the same dose without 

interruption. Consider effects of concomitant 

medicinal products, and assess and correct electrolyte 

imbalance that may prolong PR interval. Monitor 

ECG/symptoms potentially related to AV block 

closely.  

First degree AV block: 

Symptomatic  

Withhold lorlatinib. Consider effects of concomitant 

medicinal products, and assess and correct electrolyte 

imbalance that may prolong PR interval. Monitor 

ECG/symptoms potentially related to AV block 

closely. If symptoms resolve, resume lorlatinib at 

1 reduced dose level. 

Second degree AV block 

Asymptomatic  

Withhold lorlatinib. Consider effects of concomitant 

medicinal products, and assess and correct electrolyte 

imbalance that may prolong PR interval. Monitor 

ECG/symptoms potentially related to AV block 

closely. If subsequent ECG does not show second 

degree AV block, resume lorlatinib at 1 reduced dose 

level. 

Second degree AV block 

Symptomatic  

Withhold lorlatinib. Consider effects of concomitant 

medicinal products, and assess and correct electrolyte 

imbalance that may prolong PR interval. Refer for 

cardiac observation and monitoring. Consider 

pacemaker placement if symptomatic AV block 

persists. If symptoms and the second-degree AV block 

resolve or if patients revert to asymptomatic 

first-degree AV block, resume lorlatinib at 1 reduced 

dose level. 

Complete AV block 

Withhold lorlatinib. Consider effects of concomitant 

medicinal products, and assess and correct electrolyte 

imbalance that may prolong PR interval. Refer for 

cardiac observation and monitoring. Pacemaker 

placement may be indicated for severe symptoms 

associated with AV block. If AV block does not 

resolve, placement of a permanent pacemaker may be 

considered.  

If pacemaker placed, resume lorlatinib at full dose. If 

no pacemaker placed, resume lorlatinib at 1 reduced 

dose level only when symptoms resolve, and PR 

interval is less than 200 msec. 



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Table 1. Recommended lorlatinib dose modifications for adverse reactions 

Adverse reactiona Lorlatinib dosing 

Other adverse reactions 

Grade 1: Mild  

 

OR  

 

Grade 2: Moderate  

Consider no dose modification or reduce by 1 dose 

level, as clinically indicated.  

Greater than or equal to Grade 3: Severe 

Withhold lorlatinib until symptoms resolve to less than 

or equal to Grade 2 or baseline. Then resume lorlatinib 

at 1 reduced dose level. 
Abbreviations: CTCAE=Common Terminology Criteria for Adverse Events; ECG=electrocardiogram; 

HMG CoA=3-hydroxy-3-methylglutaryl coenzyme A; NCI=National Cancer Institute; ULN=upper limit of 

normal. 
a Grade categories are based on NCI CTCAE classifications. 
b Lipid-lowering therapy may include: HMG CoA reductase inhibitor, nicotinic acid, fibric acid derivatives, or 

ethyl esters of omega-3 fatty acids.  

 
Strong cytochrome P-450 (CYP) 3A4/5 inhibitors 

Concurrent use of lorlatinib with medicinal products that are strong CYP3A4/5 inhibitors and 

grapefruit juice products may increase lorlatinib plasma concentrations. An alternative concomitant 

medicinal product with less potential to inhibit CYP3A4/5 should be considered (see section 4.5). If a 

strong CYP3A4/5 inhibitor must be co-administered, the starting lorlatinib dose of 100 mg once daily 

should be reduced to once daily 75 mg dose (see sections 4.5 and 5.2). If concurrent use of the strong 

CYP3A4/5 inhibitor is discontinued, lorlatinib should be resumed at the dose used prior to the 

initiation of the strong CYP3A4/5 inhibitor and after a washout period of 3 to 5 half-lives of the strong 

CYP3A4/5 inhibitor. 

 

Special populations 

 

Elderly (≥ 65 years) 

Due to the limited data on this population, no dose recommendation can be made for patients aged 

65 years and older (see section 5.2).   

 

Renal impairment 

No dose adjustment is needed for patients with normal renal function and mild or moderate 

(CLcr: ≥ 30mL/min) renal impairment based on a population pharmacokinetic analysis. Information for 

lorlatinib use in patients with severe (CLcr: < 30 mL/min) renal impairment is very limited. Therefore, 

lorlatinib is not recommended in patients with severe renal impairment (see section 5.2). 

 

Hepatic impairment 

No dose adjustments are recommended for patients with mild hepatic impairment. No information is 

available for lorlatinib in patients with moderate or severe hepatic impairment. Therefore, lorlatinib is 

not recommended in patients with moderate to severe hepatic impairment (see section 5.2). 

 

Paediatric population 

The safety and efficacy of lorlatinib in paediatric patients below 18 years have not been established. 

No data are available.  

 

Method of administration  

 

Lorviqua is for oral use.  

 

Patients should be encouraged to take their dose of lorlatinib at approximately the same time each day 

with or without food (see section 5.2). The tablets should be swallowed whole (tablets should not be 

chewed, crushed or split prior to swallowing). No tablet should be ingested if it is broken, cracked, or 

otherwise not intact. 



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4.3 Contraindications 

 

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

 

Concomitant use of strong CYP3A4/5 inducers (see sections 4.4 and 4.5). 

 

4.4 Special warnings and precautions for use 

 

Hyperlipidaemia 

 

The use of lorlatinib has been associated with increases in serum cholesterol and triglycerides (see 

section 4.8). Median time of occurrence of severe increase in serum cholesterol and triglycerides is 

201 days (range: 42 to 518 days) and 127 days (range: 15 to 358 days), respectively. Serum 

cholesterol and triglycerides should be monitored before initiation of lorlatinib; 2, 4 and 8 weeks after 

initiating lorlatinib; and regularly thereafter. Initiate or increase the dose of lipid-lowering medicinal 

products, if indicated (see section 4.2). 

 

Central nervous system effects 

 

Central nervous system (CNS) effects have been observed in patients receiving lorlatinib, including 

psychotic effects and changes in cognitive function, mood, mental status or speech (see section 4.8). 

Dose modification or discontinuation may be required for those patients who develop CNS effects (see 

section 4.2). 

 

Atrioventricular block 

 

Lorlatinib was studied in a population of patients that excluded those with second-degree or 

third-degree AV block (unless paced) or any AV block with PR interval > 220 msec. PR interval 

prolongation and AV block have been reported in patients receiving lorlatinib (see section 5.2). 

Monitor electrocardiogram (ECG) prior to initiating lorlatinib and monthly thereafter, particularly in 

patients with predisposing conditions to the occurrence of clinically significant cardiac events. Dose 

modification may be required for those patients who develop AV block (see section 4.2).  

 

Left ventricular ejection fraction decrease 

 

Left ventricular ejection fraction (LVEF) decrease has been reported in patients receiving lorlatinib 

who had baseline and at least one follow-up LVEF assessment. Based on the available clinical study 

data, it is not possible to determine a causal relationship between effects on changes in cardiac 

contractility and lorlatinib. In patients with cardiac risk factors and those with conditions that can 

affect LVEF, cardiac monitoring, including LVEF assessment at baseline and during treatment, should 

be considered. In patients who develop relevant cardiac signs/symptoms during treatment, cardiac 

monitoring, including LVEF assessment, should be considered. 

 

Lipase and amylase increase  

 

Elevations of lipase and/or amylase have occurred in patients receiving lorlatinib (see section 4.8). 

Median time of occurrence of increase in serum lipase and amylase is 70 days (range: 7 to 696 days) 

and 41 days (range: 7 to 489 days), respectively. Risk of pancreatitis should be considered in patients 

receiving lorlatinib due to concomitant hypertriglyceridemia and/or a potential intrinsic mechanism. 

Patients should be monitored for lipase and amylase elevations prior to the start of lorlatinib treatment 

and regularly thereafter as clinically indicated (see section 4.2).  

 

Interstitial lung disease/Pneumonitis  

 

Severe or life-threatening pulmonary adverse reactions consistent with ILD/pneumonitis have 

occurred with lorlatinib (see section 4.8). Any patient who presents with worsening of respiratory 



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symptoms indicative of ILD/pneumonitis (e.g. dyspnoea, cough and fever) should be promptly 

evaluated for ILD/pneumonitis. Lorlatinib should be withheld and/or permanently discontinued based 

on severity (see section 4.2). 

 

Drug-drug interactions 

 

In a study conducted in healthy volunteers, the concomitant use of lorlatinib and rifampin, a strong 

CYP3A4/5 inducer, was associated with increases of alanine aminotransferase (ALT) and aspartate 

aminotransferase (AST) with no increase of total bilirubin and alkaline phosphatase (see section 4.5). 

Concomitant use of a strong CYP3A4/5 inducer is contraindicated (see sections 4.3 and 4.5). 

 

Concomitant use with moderate CYP3A4/5 inducers should be avoided, if possible, as they may also 

reduce lorlatinib plasma concentrations (see section 4.5). 

 

Concurrent administration of lorlatinib with CYP3A4/5 substrates with narrow therapeutic indices, 

including but not limited to alfentanil, ciclosporin, dihydroergotamine, ergotamine, fentanyl, hormonal 

contraceptives, pimozide, quinidine, sirolimus and tacrolimus, should be avoided since the 

concentration of these medicinal products may be reduced by lorlatinib (see section 4.5). 

 

Fertility and pregnancy 

 

During treatment with lorlatinib and for at least 14 weeks after the final dose, male patients with 

female partners of childbearing potential must use effective contraception, including a condom, and 

male patients with pregnant partners must use condoms (see section 4.6). Male fertility may be 

compromised during treatment with lorlatinib (see section 5.3). Men should seek advice on effective 

fertility preservation before treatment. Women of childbearing potential should be advised to avoid 

becoming pregnant while receiving lorlatinib. A highly effective non-hormonal method of 

contraception is required for female patients during treatment with lorlatinib, because lorlatinib can 

render hormonal contraceptives ineffective (see sections 4.5 and 4.6). If a hormonal method of 

contraception is unavoidable, then a condom must be used in combination with the hormonal method. 

Effective contraception must be continued for at least 35 days after completing therapy (see 

section 4.6). It is not known whether lorlatinib affects female fertility.  

 

Lactose intolerance 

 

This medicinal product contains lactose as an excipient. Patients with rare hereditary problems of 

galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this 

medicinal product. 

 

Dietary sodium 

 

This medicinal product contains less than 1 mmol sodium (23 mg) per 25 mg or 100 mg tablet. 

Patients on low sodium diets should be informed that this product is essentially “sodium-free”.  

 

4.5 Interaction with other medicinal products and other forms of interaction 

 

Pharmacokinetic interactions 

 

In vitro data indicate that lorlatinib is primarily metabolised by CYP3A4 and uridine 

diphosphate-glucuronosyltransferase (UGT)1A4, with minor contributions from CYP2C8, CYP2C19, 

CYP3A5 and UGT1A3.  

 



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Effect of medicinal products on lorlatinib 

 

CYP3A4/5 inducers 

 

Rifampin, a strong inducer of CYP3A4/5, administered at oral doses of 600 mg once daily for 12 days, 

reduced the mean lorlatinib area under curve (AUCinf) by 85% and Cmax by 76% of a single 100 mg 

oral dose of lorlatinib in healthy volunteers; increases in AST and ALT were also observed. 
Concomitant administration of lorlatinib with strong CYP3A4/5 inducers (e.g. rifampicin, 

carbamazepine, enzalutamide, mitotane, phenytoin and St. John’s wort) may decrease lorlatinib 

plasma concentrations. The use of a strong CYP3A4/5 inducer with lorlatinib is contraindicated (see 

sections 4.3 and 4.4). Concomitant use with moderate CYP3A4/5 inducers should be avoided, if 

possible, as they may also reduce lorlatinib plasma concentrations (see section 4.4).  

 

CYP3A4/5 inhibitors 

 

Itraconazole, a strong inhibitor of CYP3A4/5, administered at oral doses of 200 mg once daily for 

5 days, increased the mean lorlatinib AUCinf by 42% and Cmax by 24% of a single 100 mg oral dose of 

lorlatinib in healthy volunteers. Concomitant administration of lorlatinib with strong CYP3A4/5 

inhibitors (e.g. boceprevir, cobicistat, itraconazole, ketoconazole, posaconazole, troleandomycin, 

voriconazole, ritonavir, paritaprevir in combination with ritonavir and ombitasvir and/or dasabuvir, 

and ritonavir in combination with either elvitegravir, indinavir, lopinavir or tipranavir) may increase 

lorlatinib plasma concentrations. Grapefruit products may also increase lorlatinib plasma 

concentrations and should be avoided. An alternative concomitant medicinal product with less 

potential to inhibit CYP3A4/5 should be considered. If a strong CYP3A4/5 inhibitor must be 

concomitantly administered, a dose reduction of lorlatinib is recommended (see section 4.2).  

 

Effect of lorlatinib on other medicinal products 

 

CYP3A4/5 substrates 

 

In vitro studies indicated that lorlatinib is a time-dependent inhibitor as well as an inducer of 

CYP3A4/5. Lorlatinib 150 mg orally once daily for 15 days decreased AUCinf and Cmax of a single oral 

2 mg dose of midazolam (a sensitive CYP3A substrate) by 61% by 50%, respectively; hence, 

lorlatinib is a moderate CYP3A inducer. Thus, concurrent administration of lorlatinib with CYP3A4/5 

substrates with narrow therapeutic indices, including but not limited to alfentanil, ciclosporin, 

dihydroergotamine, ergotamine, fentanyl, hormonal contraceptives, pimozide, quinidine, sirolimus and 

tacrolimus, should be avoided since the concentration of these medicinal products may be reduced by 

lorlatinib (see section 4.4).  

 
CYP2B6 substrates 

 

Lorlatinib 100 mg once daily for 15 days decreased AUCinf and Cmax of a single oral 100 mg dose of 

bupropion (a combined CYP2B6 and CYP3A4 substrate) by 49.5% and 53%, respectively. Thus, 

lorlatinib is a weak inducer of CYP2B6, and no dose adjustment is necessary when lorlatinib is used in 

combination with medicinal products that are mainly metabolised by CYP2B6. 

 

CYP2C9 substrates 

 

Lorlatinib 100 mg once daily for 15 days decreased AUCinf and Cmax of a single oral 500 mg dose of 

tolbutamide (a sensitive CYP2C9 substrate) by 43% and 15%, respectively. Thus, lorlatinib is a weak 

inducer of CYP2C9, and no dose adjustment is required for medicinal products that are mainly 

metabolised by CYP2C9. However, patients should be monitored in case of concomitant treatment 

with medicinal products with narrow therapeutic indices metabolised by CYP2C9 (e.g. coumarin 

anticoagulants). 

 

UGT substrates 

 



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Lorlatinib 100 mg once daily for 15 days decreased AUCinf and Cmax of a single oral 500 mg dose of 

acetaminophen (a UGT, SULT and CYP1A2, 2A6, 2D6, and 3A4 substrate) by 45% and 28%, 

respectively. Thus, lorlatinib is a weak inducer of UGT, and no dose adjustment is required for 

medicinal products that are mainly metabolised by UGT. However, patients should be monitored in 

case of concomitant treatment with medicinal products with narrow therapeutic indices metabolised by 

UGT.  

 

P-glycoprotein substrates 

 

Lorlatinib 100 mg once daily for 15 days decreased AUCinf and Cmax of a single oral dose of 60 mg 

fexofenadine [a sensitive P-glycoprotein (P-gp) substrate] by 67% and 63%, respectively. Thus, 

lorlatinib is a moderate inducer of P-gp. Medicinal products that are P-gp substrates with narrow 

therapeutic indices (e.g. digoxin, dabigatran etexilate) should be used with caution in combination 

with lorlatinib due to the likelihood of reduced plasma concentrations of these substrates. 

 

In vitro inhibition and induction studies of other CYP enzymes 

 

In vitro, lorlatinib has a low potential to cause drug-drug interactions by induction of CYP1A2. 

 

In vitro studies with drug transporters other than P-gp 

 

In vitro studies indicated that lorlatinib may have the potential to inhibit BCRP (gastrointestinal tract), 

OATP1B1, OATP1B3, OCT1, MATE1 and OAT3 at clinically relevant concentrations. Lorlatinib 

should be used with caution in combination with substrates of BCRP, OATP1B1, OATP1B3, OCT1, 

MATE1 and OAT3 as clinically relevant changes in the plasma exposure of these substrates cannot be 

ruled out.  

 

4.6 Fertility, pregnancy and lactation 

 

Women of childbearing potential/Contraception in males and females 

 

Women of childbearing potential should be advised to avoid becoming pregnant while receiving 

lorlatinib. A highly effective non-hormonal method of contraception is required for female patients 

during treatment with lorlatinib, because lorlatinib can render hormonal contraceptives ineffective (see 

sections 4.4 and 4.5). If a hormonal method of contraception is unavoidable, then a condom must be 

used in combination with the hormonal method. Effective contraception must be continued for at least 

35 days after completing therapy.  

 

During treatment with lorlatinib and for at least 14 weeks after the final dose, male patients with 

female partners of childbearing potential must use effective contraception, including a condom, and 

male patients with pregnant partners must use condoms. 

 

Pregnancy 

 

Studies in animals have shown embryo-foetal toxicity (see section 5.3). There are no data from the use 

of lorlatinib in pregnant women. Lorlatinib may cause foetal harm when administered to a pregnant 

woman.  

 

Lorlatinib is not recommended during pregnancy or for women of childbearing potential not using 

contraception. 

 

Breast-feeding 

 

It is unknown whether lorlatinib and its metabolites are excreted in human milk. A risk to the 

newborns/infants cannot be excluded. 

 



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Lorlatinib should not be used during breast-feeding. Breast-feeding should be discontinued during 

treatment with lorlatinib and for 7 days after the final dose.  

 

Fertility 

 

Based on non-clinical safety findings, male fertility may be compromised during treatment with 

lorlatinib (see section 5.3). It is not known whether lorlatinib affects female fertility. Men should seek 

advice on effective fertility preservation before treatment. 

 

4.7 Effects on ability to drive and use machines 

 

Lorlatinib has moderate influence on the ability to drive and use machines. Caution should be 

exercised when driving or operating machines as patients may experience CNS effects (see 

section 4.8).  

 

4.8 Undesirable effects 

 

Summary of the safety profile 

 

The most frequently reported adverse reactions were hypercholesterolaemia (84.4%), 

hypertriglyceridaemia (67.1%), oedema (54.6%), peripheral neuropathy (47.8%), cognitive effects 

(28.8%), fatigue (28.1%), weight increased (26.4%), arthralgia (24.7%), mood effects (22.7%) and 

diarrhoea (22.7%).   

 

Dose reductions due to adverse reactions occurred in 23.4% of patients receiving lorlatinib. The most 

common adverse reactions that led to dose reductions were oedema and peripheral neuropathy. 

Permanent treatment discontinuation associated with adverse reactions occurred in 3.1% of patients 

receiving lorlatinib. The most frequent adverse reactions that led to permanent discontinuations were 

cognitive effects and psychotic effects. 

 

Tabulated list of adverse reactions 

 

Table 2 presents adverse reactions occurring in 295 adult patients treated with lorlatinib 100 mg once 

daily with advanced NSCLC from Study A. 

 

The adverse reactions listed in Table 2 are presented by system organ class and frequency categories, 

defined using the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), 

uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000). Within each 

frequency grouping, undesirable effects are presented in order of decreasing medical seriousness. 

 



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Table 2. Adverse reactions  

System organ class and adverse 

reaction 

Frequency category 

 

All Grades 

% 

Grades 3-4 

% 

Blood and lymphatic system disorders 

Anaemia 

 

Very common 

 

15.9 

 

5.1 

Metabolism and nutrition disorders 

Hypercholesterolaemiaa 

Hypertriglyceridaemiab 

 

Very common 

Very common  

 

84.4 

67.1 

 

16.6 

16.6 

Psychiatric disorders 

Mood effectsc 

Psychotic effectsd  

Mental status changes  

 

Very common 

Common 

Common 

 

22.7 

7.8 

2.0 

 

1.7 

1.0 

1.7 

Nervous system disorders 

Cognitive effectse  

Peripheral neuropathyf  

Headache 

Speech effectsg 

 

Very common 

Very common 

Very common 

Common 

 

28.8 

47.8 

18.0 

9.8 

 

2.0 

2.7 

0.7 

0.3 

Eye disorders 

Vision disorderh 

 

Very common 

 

15.3 

 

0.3 

Respiratory, thoracic and mediastinal 

disorders 

Pneumonitisi  

 

 

Common 

 

 

1.4 

 

 

1.0 

Gastrointestinal disorders 

Diarrhoea 

Nausea 

Constipation  

 

Very common 

Very common 

Very common  

 

22.7 

18.3 

15.9 

 

1.0 

0.7 

0 

Skin and subcutaneous tissue disorders 

Rashj  

 

Very common 

 

14.2 

 

0.3 

Musculoskeletal and connective tissue 

disorders 

Arthralgia 

Myalgiak  

 

 

Very common 

Very common 

 

 

24.7 

19.3 

 

 

0.7 

0 

General disorders and administration site 

conditions 

Oedemal 

Fatiguem  

 

 

Very common 

Very common 

 

 

54.6 

28.1 

 

 

2.4 

0.7 

Investigations 

Weight increased 

Lipase increased 

Amylase increased 

Electrocardiogram PR prolongation 

 

Very common 

Very common 

Very common 

Uncommon 

 

26.4 

13.9 

10.2 

0.7 

 

5.4 

8.8 

3.1 

0 
Adverse reactions that represent the same medical concept or condition were grouped together and reported as 

a single adverse reaction in the table above. Terms actually reported in the studies and contributing to the 

relevant adverse reaction are indicated in parentheses, as listed below. 
a Hypercholesterolaemia (including blood cholesterol increased, hypercholesterolaemia). 
b Hypertriglyceridaemia (including blood triglycerides increased, hypertriglyceridaemia). 
c Mood effects (including affective disorder, affect lability, aggression, agitation, anxiety, depressed mood, 

depression, euphoric mood, irritability, mania, mood altered, mood swings, personality change, stress).  
d Psychotic effects (including auditory hallucination, hallucination, visual hallucination). 
e Cognitive effects (including events from SOC Nervous system disorders: amnesia, cognitive disorder, 

dementia, disturbance in attention, memory impairment, mental impairment; and also including events 

from SOC Psychiatric disorders: attention deficit/hyperactivity disorder, confusional state, delirium, 

disorientation, reading disorder). Within these effects, terms from SOC Nervous system disorders were 

more frequently reported than terms from SOC Psychiatric disorder.  
f Peripheral neuropathy (including burning sensation, carpal tunnel syndrome, dysaesthesia, formication, gait 

disturbance, hypoaesthesia, muscular weakness, neuralgia, neuropathy peripheral, neurotoxicity, 

paraesthesia, peripheral sensory neuropathy, peroneal nerve palsy, sensory disturbance). 
g Speech effects (dysarthria, slow speech, speech disorder). 



13 

h Vision disorder (including diplopia, photophobia, photopsia, vision blurred, visual acuity reduced, visual 

impairment, vitreous floaters). 
i Pneumonitis (including interstitial lung disease, pneumonitis). 
j Rash (including dermatitis acneiform, maculopapular rash, pruritic rash, rash). 
k Myalgia (including musculoskeletal pain, myalgia). 
l Oedema (including generalised oedema, oedema, oedema peripheral, peripheral swelling, swelling). 
m Fatigue (including asthenia, fatigue).  

 

Description of selected adverse reactions  

 

Hypercholesterolaemia/hypertriglyceridaemia 

Adverse reactions of increase in serum cholesterol or triglycerides were reported in 84.4% and 67.1% 

of patients, respectively. Of those, mild or moderate adverse reactions of hypercholesterolaemia or 

hypertriglyceridaemia occurred in 67.8% and 50.5% of patients, respectively (see section 4.4). The 

median time to onset for both hypercholesterolaemia and hypertriglyceridaemia was 15 days (range: 

1 to 399 days). The median duration of hypercholesterolaemia and hypertriglyceridaemia was 381 and 

405 days, respectively. 

 

Central nervous system effects 

CNS adverse reactions were primarily cognitive effects (28.8%), mood effects (22.7%), speech effects 

(9.8%) and psychotic effects (7.8%), and were generally mild, transient, and reversible spontaneously 

upon dose delay and/or dose reduction (see sections 4.2 and 4.4). The most common cognitive effect 

of any grade was memory impairment (11.5%), and the most common Grade 3 or 4 reactions were 

cognitive effect and confusional state (0.7% each). The most common mood effect of any grade was 

irritability (6.1%), which was also the most common Grade 3 or 4 reaction (1.0%). The most common 

speech effect of any grade was dysarthria (4.1%), and the most common Grade 3 or 4 reaction was 

slow speech (0.3%). The most common psychotic effect of any grade was hallucination (3.7%) and the 

most common Grade 3 or 4 reactions were hallucination, hallucination auditory and hallucination 

visual (0.3% each). Median time to onset for cognitive, mood, speech and psychotic effects was 92, 

44, 42 and 23 days, respectively. Median duration of cognitive, mood, speech and psychotic effects 

was 224, 83, 106 and 74 days, respectively.   

 

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 

 

Treatment of overdose with the medicinal product consists of general supportive measures. Given the 

dose-dependent effect on PR interval, ECG monitoring is recommended. There is no antidote for 

lorlatinib.  

 

 

5. PHARMACOLOGICAL PROPERTIES 

 

5.1  Pharmacodynamic properties 

 

Pharmacotherapeutic group: anti-neoplastic agents, protein kinase inhibitors, ATC code: L01XE44 

 

Mechanism of action 

 

Lorlatinib is a selective, adenosine triphosphate (ATP)-competitive inhibitor of ALK and c-ros 

oncogene 1 (ROS1) tyrosine kinases. 

 

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


14 

In non-clinical studies, lorlatinib inhibited catalytic activities of non-mutated ALK and clinically 

relevant ALK mutant kinases in recombinant enzyme and cell-based assays. Lorlatinib demonstrated 

marked antitumour activity in mice bearing tumour xenografts that express echinoderm 

microtubule-associated protein-like 4 (EML4) fusions with ALK variant 1 (v1), including ALK 

mutations L1196M, G1269A, G1202R, and I1171T. Two of these ALK mutants, G1202R and I1171T, 

are known to confer resistance to alectinib, brigatinib, ceritinib, and crizotinib. Lorlatinib was also 

capable of penetrating the blood-brain barrier. Lorlatinib demonstrated activity in mice bearing 

orthotopic EML4-ALK or EML4-ALKL1196M brain tumour implants.  
 

Clinical efficacy  

The use of lorlatinib in the treatment of ALK-positive advanced NSCLC after treatment with at least 

one second-generation ALK TKI was investigated in Study A, a single-arm, multicentre Phase 1/2 

study. A total of 139 patients with ALK-positive advanced NSCLC after treatment with at least one 

second-generation ALK TKI were enrolled in the Phase 2 portion of the study. Patients received 

lorlatinib orally at the recommended dose of 100 mg once daily, continuously. 

 

The primary efficacy endpoint in the Phase 2 portion of the study was objective response rate (ORR), 

including intracranial (IC)-ORR, as per Independent Central Review (ICR) according to modified 

response evaluation criteria in solid tumours (modified RECIST version 1.1). Secondary endpoints 

included duration of response (DOR), IC-DOR, time-to-tumour response (TTR), and progression-free 

survival (PFS). 

 

Patient demographics of the 139 ALK-positive advanced NSCLC patients after treatment with at least 

one second-generation ALK TKI, were 56% female, 48% White, 38% Asian, and the median age was 

53 years (range: 29-83 years) with 16% of patients ≥ 65 years of age. The Eastern Cooperative 

Oncology Group (ECOG) performance status at baseline was 0 or 1 in 96% patients. Brain metastases 

were present at baseline in 67% of patients. Of the 139 patients, 20% received 1 prior ALK TKI, 

excluding crizotinib, 47% received 2 prior ALK TKIs, and 33% received 3 or more prior ALK TKIs. 

 

The main efficacy results for Study A are included in Tables 3 and 4. 

 

Table 3. Overall efficacy results in Study A by prior treatment  

Efficacy parameter 

One prior ALK TKIa with 

or without 

prior chemotherapy 

Two or more prior ALK 

TKIs with or without prior 

chemotherapy 

(N = 28) (N = 111) 

Objective response rateb  

(95% CI) 

Complete response, n  

Partial response, n  

42.9% 

(24.5, 62.8) 

1 

11 

39.6% 

(30.5, 49.4) 

2 

42 

Duration of response 

Median, months 

(95% CI) 

 

5.6 

(4.2, NR) 

 

9.9 

(5.7, 24.4) 

Progression-free survival 

Median, months 

(95% CI) 

 

5.5 

(2.9, 8.2) 

 

6.9 

(5.4, 9.5) 
Abbreviations: ALK=anaplastic lymphoma kinase; CI=confidence interval; ICR=Independent Central 

Review; N/n=number of patients; NR=not reached; TKI=tyrosine kinase inhibitor. 
a Alectinib, brigatinib, or ceritinib. 
b Per ICR. 

 



15 

Table 4. Intracranial* efficacy results in Study A by prior treatment  

Efficacy parameter 

One prior ALK TKIa with 

or without 

prior chemotherapy 

Two or more prior ALK 

TKIs with or without prior 

chemotherapy 

(N = 9) (N = 48) 

Objective response rateb 

(95% CI) 

Complete response, n  

Partial response, n  

66.7% 

(29.9, 92.5) 

2 

4 

52.1% 

(37.2, 66.7) 

10 

15 

Duration of intra-cranial 

response  

Median, months 

(95% CI) 

 

 

NR 

(4.1, NR) 

 

 

12.4 

(6.0, NR) 

Abbreviations: ALK=anaplastic lymphoma kinase; CI=confidence interval; ICR=Independent 

Central Review; N/n=number of patients; NR=not reached; TKI= tyrosine kinase inhibitor. 
* In patients with at least one measurable brain metastasis at baseline. 
a Alectinib, brigatinib, or ceritinib. 
b Per ICR. 

 

In the overall efficacy population of 139 patients, 56 patients had a confirmed objective response by 

ICR with a median TTR of 1.4 months (range: 1.2 to 16.6 months). The ORR for Asians was 49.1% 

(95% CI: 35.1, 63.2) and 31.5% for non-Asians (95% CI: 21.1, 43.4). Among the 31 patients with a 

confirmed IC objective tumour response and at least one measurable brain metastasis at baseline by 

ICR, the median IC-TTR was 1.4 months (range: 1.2 to 16.2 months). The IC ORR was 54.5% for 

Asians (95% CI: 32.2, 75.6) and 46.4% for non-Asians (95% CI: 27.5, 66.1). 

 

Paediatric population 

 

The European Medicines Agency has waived the obligation to submit the results of studies with 

lorlatinib in all subsets of the paediatric population in lung carcinoma (small cell and non-small cell 

carcinoma) (see section 4.2 for information on paediatric use). 

 

This medicinal product has been authorised under a so-called ‘conditional approval’ scheme. 

This means that further evidence on this medicinal product is awaited. 

The European Medicines Agency will review new information on this medicinal product at least every 

year and this SmPC will be updated as necessary. 

 

5.2 Pharmacokinetic properties  

 

Absorption  

 

Peak lorlatinib concentrations in plasma are rapidly reached with the median Tmax of 1.2 hours 

following a single 100 mg dose and 2.0 hours following multiple dosing of 100 mg once daily.  

 

After oral administration of lorlatinib tablets, the mean absolute bioavailability is 80.8% (90% CI: 

75.7, 86.2) compared to intravenous administration. 

 

Administration of lorlatinib with a high fat, high calorie meal resulted in 5% higher exposure 

compared to fasted conditions. Lorlatinib may be administered with or without food.  

 

At 100 mg once daily, the geometric mean (% coefficient of variation [CV]) peak plasma 

concentration was 577 (42) ng/mL and the AUC24 was 5,650 (39) ng·h/mL in patients with cancer. 

The geometric mean (% CV) oral clearance was 17.7 (39) L/h. 

 



16 

Distribution 

 

In vitro binding of lorlatinib to human plasma proteins is 66% with moderate binding to albumin or to 

α1-acid glycoprotein.  

 

Biotransformation 

 

In humans, lorlatinib undergoes oxidation and glucuronidation as the primary metabolic pathways. 

In vitro data indicate that lorlatinib is metabolised primarily by CYP3A4 and UGT1A4, with minor 

contribution from CYP2C8, CYP2C19, CYP3A5 and UGT1A3.  

 

In plasma, a benzoic acid metabolite of lorlatinib resulting from the oxidative cleavage of the amide 

and aromatic ether bonds of lorlatinib was observed as a major metabolite, accounting for 21% of the 

circulating radioactivity. The oxidative cleavage metabolite is pharmacologically inactive. 

 

Elimination 

 

The plasma half-life of lorlatinib after a single 100 mg dose was 23.6 hours. Following oral 

administration of a 100 mg radiolabelled dose of lorlatinib, a mean 47.7% of the radioactivity was 

recovered in urine and 40.9% of the radioactivity was recovered in faeces, with overall mean total 

recovery of 88.6%.   

 

Unchanged lorlatinib was the major component of human plasma and faeces, accounting for 44% and 

9.1% of total radioactivity, respectively. Less than 1% of unchanged lorlatinib was detected in urine.  

 

Furthermore, lorlatinib is an inducer via human pregnane-X-receptor (PXR) and the human 

constitutive androstane receptor (CAR).   

 

Linearity/non-linearity 

 

At single dose, lorlatinib systemic exposure (AUCinf and Cmax) increased in a dose-related manner over 

the 10 to 200 mg dose range. Few data are available over the 10 to 200 mg dose range; however, no 

deviation from linearity was observed for AUCinf and Cmax after single dose. 

 

After multiple once daily dose administration, lorlatinib Cmax increased dose-proportionally and 

AUCtau increased slightly less than proportionally over the dose range of 10 to 200 mg once daily. 

 

Also, at steady-state lorlatinib plasma exposures are lower than those expected from single dose 

pharmacokinetics, indicative of a net time-dependent auto-induction effect.  

 

Hepatic impairment 

 

As lorlatinib is metabolised in the liver, hepatic impairment is likely to increase lorlatinib plasma 

concentrations. Clinical studies that were conducted excluded patients with AST or ALT > 2.5 × ULN, 

or if due to underlying malignancy, > 5.0 × ULN or with total bilirubin > 1.5 × ULN. Population 

pharmacokinetic analyses have shown that lorlatinib exposure was not clinically meaningfully altered 

in patients with mild hepatic impairment (n = 50). No dose adjustments are recommended for patients 

with mild hepatic impairment. No information is available for patients with moderate or severe hepatic 

impairment. 

 

Renal impairment 

 

Less than 1% of the administered dose is detected as unchanged lorlatinib in urine. Population 

pharmacokinetic analyses have shown that lorlatinib exposure was not clinically meaningfully altered 

in patients with mild (n = 103) or moderate (n = 41) renal impairment (CLcr > 30 mL/min). No starting 



17 

dose adjustments are recommended for patients with mild or moderate renal impairment. Information 

for lorlatinib use in patients with severe renal impairment (CLcr < 30 mL/min) is limited (n = 1). 

 

Age, gender, race, body weight, and phenotype 

 

Population pharmacokinetic analyses in patients with advanced NSCLC and healthy volunteers 

indicate that there are no clinically relevant effects of age, gender, race, body weight, and phenotypes 

for CYP3A5 and CYP2C19. 

 

Cardiac electrophysiology  

 

In Study A, 2 patients (0.7%) had absolute Fridericia’s correction QTc (QTcF) values > 500 msec and 

5 patients (1.8%) had a change in QTcF from baseline > 60 msec.  

 

In addition, the effect of a single oral dose of lorlatinib (50 mg, 75 mg, and 100 mg) with and without 

200 mg once daily itraconazole was evaluated in a 2-way crossover study in 16 healthy volunteers. No 

increases in the mean QTc were observed at the mean observed lorlatinib concentrations in this study. 

 

In 295 patients who received lorlatinib at the recommended dose of 100 mg once daily and had a ECG 

measurement in Study A, lorlatinib was studied in a population of patients that excluded those with 

QTc interval > 470 msec. In the study population, the maximum mean change from baseline for PR 

interval was 16.4 msec (2-sided 90% upper CI 19.4 msec) (see sections 4.2, 4.4 and 4.8). Of these, 

7 patients had a baseline PR > 200 msec. Among the 284 patients with PR interval < 200 msec, 14% 

had PR interval prolongation ≥ 200 msec after starting lorlatinib. The prolongation of PR interval 

occurred in a concentration-dependent manner. Atrioventricular block occurred in 1.0% of patients.  

 

For those patients who develop PR prolongation, dose modification may be required (see section 4.2). 

 

5.3 Preclinical safety data 

 

Repeat-dose toxicity 

 

The main toxicities observed were inflammation across multiple tissues (skin and cervix of rats and 

lung, trachea, skin, lymph nodes and/or the oral cavity including mandibular bone of dogs; associated 

with increases in white blood cells, fibrinogen, and/or globulin and decreases in albumin) and changes 

in the pancreas (with increases in amylase and lipase), hepatobiliary system (with increases in liver 

enzymes), male reproductive system, cardiovascular system, kidneys and gastrointestinal tract, 

peripheral nerves and the CNS (potential for cognitive functional impairment) at dose equivalent to 

human clinical exposure at the recommended posology. Changes in blood pressure and heart rate, and 

QRS complex and PR interval were also observed in animals after acute dosing (approximately 

2.6 times the human clinical exposure at 100 mg after a single dose based on Cmax). All target organ 

findings with the exception of hepatic bile duct hyperplasia were partially to fully reversible. 

 

Genotoxicity 

 

Lorlatinib is not mutagenic but is aneugenic in vitro and in vivo with a no observed effect level for 

aneugenicity approximately 16.5 times human clinical exposure at 100 mg based on AUC.  

 

Carcinogenicity 

 

Carcinogenicity studies have not been conducted with lorlatinib. 

 

Reproductive toxicity 

 

Seminiferous tubular degeneration and/or atrophy in the testes, and epididymal changes (inflammation 

and/or vacuolation) were observed in the rat and dog. In the prostate, minimal to mild glandular 



18 

atrophy was observed in dogs at dose equivalent to human clinical exposure at the recommended 

posology). The effects on male reproductive organs were partially to fully reversible. 

 

In embryo-foetal toxicity studies, conducted in rats and rabbits, respectively, increased 

embryolethality and lower foetal body weights and malformations were observed. Foetal morphologic 

abnormalities included rotated limbs, supernumerary digits, gastroschisis, malformed kidneys, domed 

head, high arched palate, and dilation of ventricles of the brain. The exposure at the lowest doses with 

embryo-foetal effects in animals was equivalent to the human clinical exposure at 100 mg, based on 

AUC. 

 

 

6. PHARMACEUTICAL PARTICULARS 

 

6.1 List of excipients 

 

Tablet core 

 

Microcrystalline cellulose 

Calcium hydrogen phosphate 

Sodium starch glycolate 

Magnesium stearate 

 

Film-coating 

 

Hypromellose  

Lactose monohydrate 

Macrogol  

Triacetin 

Titanium dioxide (E171) 

Iron oxide black (E172) 

Iron oxide red (E172) 

 

6.2 Incompatibilities 

 

Not applicable.  

 

6.3 Shelf life 

 

3 years. 

 

6.4 Special precautions for storage 

 

This medicinal product does not require any special storage conditions.  

 

6.5 Nature and contents of container  

 

OPA/Al/PVC blisters with aluminium foil backing containing 10 film-coated tablets.  

 

Lorviqua 25 mg film-coated tablets 

 

Each pack contains 90 film-coated tablets in 9 blisters or 120 film-coated tablets in 12 blisters. 

 

Lorviqua 100 mg film-coated tablets 

 

Each pack contains 30 film-coated tablets in 3 blisters. 

 

Not all pack sizes may be marketed. 



19 

 

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 

 

Pfizer Europe MA EEIG 

Boulevard de la Plaine 17 

1050 Bruxelles 

Belgium 

 

 

8. MARKETING AUTHORISATION NUMBER(S)  

 

EU/1/19/1355/001 

EU/1/19/1355/002 

EU/1/19/1355/003 

 

 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 

 

Date of first authorisation: 6 May 2019 

Date of latest renewal: 3 April 2020 

 

 

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. 

  

http://www.ema.europa.eu/


20 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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 

 

E. SPECIFIC OBLIGATION TO COMPLETE POST-

AUTHORISATION MEASURES FOR THE CONDITIONAL 

MARKETING AUTHORISATION 



21 

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 

 

Name and address of the manufacturer responsible for batch release 

 

Pfizer Manufacturing Deutschland GmbH 

Betriebsstätte Freiburg 

Mooswaldallee 1 

79090 Freiburg 

Germany 

 

 

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. 

 

The marketing authorisation holder (MAH) shall submit the first PSUR for this product within 

6 months following authorisation.  

 

 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT   

 

• Risk management plan (RMP) 

 

The 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. 

 

 



22 

E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES 

FOR THE CONDITIONAL MARKETING AUTHORISATION 

 

This being a conditional marketing authorisation and pursuant to Article 14a(4) of Regulation (EC) 

No 726/2004, the MAH shall complete, within the stated timeframe, the following measures: 
 

Description Due date 

In order to further confirm the efficacy and safety of lorlatinib in the treatment of 

patients with ALK-positive NSCLC, the MAH should submit the clinical study 

report of the phase III study CROWN (1006) comparing lorlatinib versus 

crizotinib for the first-line treatment of advanced ALK-positive NSCLC. The 

clinical study report will be submitted by:  

31 December 

2021 

In order to further confirm the efficacy of lorlatinib in patients who progressed 

after alectinib or ceritinib as the first ALK TKI therapy, the MAH should conduct 

a prospective single arm study investigating patients in that same setting. The 

clinical study report will be submitted by: 

30 June 2024 

 
  



23 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX III 

 

LABELLING AND PACKAGE LEAFLET 

  



24 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

A. LABELLING 

  



25 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

CARTON  

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Lorviqua 25 mg film-coated tablets 

lorlatinib 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each film-coated tablet contains 25 mg of lorlatinib. 

 

 

3. LIST OF EXCIPIENTS 

 

Contains lactose (see leaflet for further information). 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

90 film-coated tablets 

120 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 

 

 



26 

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 

 

Pfizer Europe MA EEIG 

Boulevard de la Plaine 17 

1050 Bruxelles 

Belgium  

 

 

12. MARKETING AUTHORISATION NUMBER(S)  

 

EU/1/19/1355/001 120 film-coated tablets 

EU/1/19/1355/003 90 film-coated tablets 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Lorviqua 25 mg 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC  

SN  

NN  

  



27 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

BLISTER 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Lorviqua 25 mg tablets 

lorlatinib 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Pfizer (as MAH logo) 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. OTHER 

 

 

  



28 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

CARTON  

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Lorviqua 100 mg film-coated tablets 

lorlatinib 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each film-coated tablet contains 100 mg of lorlatinib. 

 

 

3. LIST OF EXCIPIENTS 

 

Contains lactose (see 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 

 

 



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 

 

Pfizer Europe MA EEIG 

Boulevard de la Plaine 17 

1050 Bruxelles 

Belgium  

 

 

12. MARKETING AUTHORISATION NUMBER(S)  

 

EU/1/19/1355/002 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Lorviqua 100 mg 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC  

SN  

NN  

  



30 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

BLISTER 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Lorviqua 100 mg tablets 

lorlatinib 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Pfizer (as MAH logo) 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. OTHER 

 

 

  



31 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

B. PACKAGE LEAFLET 



32 

Package leaflet: Information for the user 

 

Lorviqua 25 mg film-coated tablets 

Lorviqua 100 mg film-coated tablets 

lorlatinib 

 

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 Lorviqua is and what it is used for  

2. What you need to know before you take Lorviqua  

3. How to take Lorviqua  

4. Possible side effects  

5. How to store Lorviqua  

6. Contents of the pack and other information 

 

 

1. What Lorviqua is and what it is used for 

 

What Lorviqua is  

Lorviqua contains the active substance lorlatinib, a medicine that is used for treatment of adults with 

advanced stages of a form of lung cancer called non-small cell lung cancer (NSCLC). Lorviqua 

belongs to the group of medicines that inhibit an enzyme called anaplastic lymphoma kinase (ALK). 

Lorviqua is only given to patients who have an alteration in the ALK gene, see How Lorviqua works 

below.  

 

What Lorviqua is used for  

Lorviqua can be prescribed to you if 

- you have been previously treated with a medicine called alectinib or ceritinib, which are ALK 

inhibitors; or  

- you have been previously treated with crizotinib followed by another ALK inhibitor. 

How Lorviqua works 

Lorviqua inhibits a type of enzyme called tyrosine kinase and triggers the death of cancer cells in 

patients with alterations in genes for ALK. Lorviqua is only given to patients whose disease is due to 

an alteration in the gene for ALK tyrosine kinase. 

 

If you have any questions about how Lorviqua works or why this medicine has been prescribed for 

you, ask your doctor. 

 

 



33 

2. What you need to know before you take Lorviqua  

 

Do not take Lorviqua 

- if you are allergic to lorlatinib or any of the other ingredients of this medicine (listed in 

section 6). 

- if you are taking any of these medicines: 

• rifampicin (used to treat tuberculosis) 

• carbamazepine, phenytoin (used to treat epilepsy)  

• enzalutamide (used to treat prostate cancer) 

• mitotane (used to treat cancer of the adrenal glands) 

• medicines containing St. John’s wort (Hypericum perforatum, a herbal preparation) 

 

Warnings and precautions  

Talk to your doctor before taking Lorviqua: 

- if you have high levels of blood cholesterol or triglycerides  

- if you have high levels of the enzymes known as amylase or lipase in the blood or a condition 

such as pancreatitis that can raise the levels of these enzymes 

- if you have problems with your heart, including heart failure, slow heart rate, or if 

electrocardiogram (ECG) results show that you have an abnormality of the electrical activity of 

your heart known as prolonged PR interval or AV block.  

- if you have cough, chest pain, shortness of breath, or worsening of respiratory symptoms or 

have ever had a lung condition called pneumonitis.  

  

If you are not sure, talk to your doctor, pharmacist or nurse before taking Lorviqua. 

 

Tell your doctor immediately if you develop: 

- heart problems. Tell your doctor right away about changes in your heart beat (fast or slow), 

light-headedness, fainting, dizziness or shortness of breath. These symptoms could be signs of 

heart problems. Your doctor may check for problems with your heart during treatment with 

Lorviqua. If the results are abnormal, your doctor may decide to reduce the dose of Lorviqua or 

stop your treatment. 

- speech problems, difficulty speaking, including slurred or slow speech. Your doctor may 

investigate further and may decide to reduce your dose of Lorviqua or stop your treatment. 

- mental status changes, mood or memory problems, such as change in your mood (including 

depression, euphoria and mood swings), irritability, aggression, agitation, anxiety or a change in 

your personality and episodes of confusion or loss of contact with reality, such as believing, 

seeing or hearing things that are not real. Your doctor may investigate further and may decide to 

reduce your dose of Lorviqua or stop your treatment. 

- pain in the back or abdomen (belly), yellowing of the skin and eyes (jaundice), nausea or 

vomiting. These symptoms could be signs of pancreatitis. Your doctor may investigate further 

and may decide to reduce the dose of Lorviqua. 

- cough, chest pain, or a worsening of existing respiratory symptoms. Your doctor may 

investigate further and treat you with other medicines such as antibiotics and steroids. Your 

doctor may decide to reduce your dose of Lorviqua or stop your treatment. 

 

Your doctor may do further assessments and may decide to reduce the dose of Lorviqua or stop your 

treatment if you develop: 

- liver problems. Tell your doctor right away if you feel more tired than usual, your skin and 

whites of your eyes turn yellow, your urine turns dark or brown (tea colour), you have nausea, 

vomiting, or decreased appetite, you have pain on the right side of your stomach, you have 

itching, or if you bruise more easily than usual. Your doctor may do blood tests to check your 

liver function. 

 

See Possible side effects in section 4 for more information. 

 

Children and adolescents 

This medicine is only indicated in adults and it is not to be given to children and adolescents. 



34 

 

Tests and checks 

You will have blood tests before you start treatment and during your treatment. These tests are to 

check the level of cholesterol, triglycerides and the enzymes amylase or lipase in your blood before 

you start treatment with Lorviqua and regularly during treatment.  

 

Other medicines and Lorviqua 

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other 

medicines, including herbal medicines and medicines obtained over the counter. This is because 

Lorviqua can affect the way some other medicines work. Also some medicines can affect the way 

Lorviqua works. 

 

You must not take Lorviqua with certain medicines. These are listed under Do not take Lorviqua, at 

the start of section 2. 

 

In particular tell your doctor, pharmacist or nurse if you are taking any of the following medicines: 

- boceprevir – a medicine used to treat hepatitis C. 

- buproprion – a medicine used to treat depression or to help people quit smoking. 

- dihydroergotamine, ergotamine – medicines used to treat migraine headaches.  

- efavirenz, cobicistat, ritonavir, paritaprevir in combination with ritonavir and ombitasvir and/or 

dasabuvir, and ritonavir in combination with either elvitegravir, indinavir, lopinavir or 

tipranavir – medicines used to treat AIDS/HIV. 

- ketoconazole, itraconazole, voriconazole, posaconazole – medicines used to treat fungal 

infections. Also troleandomycin, a medicine used to treat certain types of bacterial infections. 

- quinidine – a medicine used to treat irregular heartbeat and other heart problems. 

- pimozide – a medicine used to treat mental health problems. 

- alfentanil and fentanyl – medicines used to treat severe pain. 

- ciclosporin, sirolimus, and tacrolimus – medicines used in organ transplantation to prevent 

organ rejection.  

 

Lorviqua with food and drink 

You must not drink grapefruit juice or eat grapefruit while on treatment with Lorviqua as they may 

change the amount of Lorviqua in your body. 

 

Pregnancy, breast-feeding and fertility  

 

- Contraception – information for women 

You should not become pregnant while taking this medicine. If you are able to have children, 

you must use highly effective contraception (for example, double-barrier contraception such as 

condom and diaphragm) while on treatment and for at least 5 weeks after stopping treatment. 

Lorlatinib may reduce the effectiveness of hormonal contraceptive methods (for example, birth 

control pill); therefore, hormonal contraceptives may not be considered highly effective. If 

hormonal contraception is unavoidable it must be used in combination with a condom. Talk to 

your doctor about the right methods of contraception for you and your partner. 

- Contraception – information for men 

You should not father children during treatment with Lorviqua because this medicine could 

harm the baby. If there is any possibility that you may father a child while taking this medicine, 

you must use a condom during treatment, and for at least 14 weeks after completing therapy. 

Talk to your doctor about the right methods of contraception for you and your partner. 

- Pregnancy 

• Do not take Lorviqua if you are pregnant. This is because it may harm your baby.  

• If your male partner is being treated with Lorviqua, he must use a condom during treatment 

and for at least 14 weeks after completing therapy.  

• If you become pregnant when taking the medicine or during the 5 weeks after taking your 

last dose, tell your doctor straight away.  

 



35 

- Breast-feeding 

Do not breast-feed while taking this medicine and for 7 days after the last dose. This is because 

it is not known if Lorviqua can pass into breast milk and could therefore harm your baby. 

- Fertility 

Lorviqua may affect male fertility. Talk to your doctor about fertility preservation before taking 

Lorviqua. 

 

Driving and using machines 

You should take special care when driving and using machines when taking Lorviqua because of its 

effects on your mental state. 

 

Lorviqua contains lactose 

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor 

before taking this medicine. 

 

Lorviqua contains sodium 

This medicine contains less than 1 mmol sodium (23 mg) per 25 mg or 100 mg tablet, that is to say 

essentially ‘sodium-free’. 

 

 

3. How to take Lorviqua 

 

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. 

- The recommended dose is one tablet of 100 mg taken by mouth once daily.  

- Take the dose at about the same time each day. 

- You can take the tablets with food or between meals always avoiding grapefruit and grapefruit 

juice. 

- Swallow the tablets whole and do not crush, chew or dissolve the tablets. 

- Sometimes your doctor may lower your dose, stop your treatment for a short time or stop your 

treatment completely if you feel unwell. 

 

If you vomit after taking Lorviqua 

If you vomit after taking a dose of Lorviqua, do not take an extra dose, just take your next dose at the 

usual time. 

 

If you take more Lorviqua than you should 

If you accidentally take too many tablets, tell your doctor, pharmacist or nurse right away. You may 

require medical attention. 

 

If you forget to take Lorviqua 

What to do if you forget to take a tablet depends on how long it is until your next dose. 

- If your next dose is in 4 hours or more, take the missed tablet as soon as you remember. Then 

take the next tablet at the usual time. 

- If your next dose is in less than 4 hours away, skip the missed tablet. Then take the next tablet at 

the usual time. 

 

Do not take a double dose to make up for a forgotten dose. 

 

If you stop taking Lorviqua 

It is important to take Lorviqua every day, for as long as your doctor asks you to. If you are not able to 

take the medicine as your doctor has prescribed, or you feel you do not need it anymore, speak with 

your doctor right away. 

 

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

 

 



36 

4. Possible side effects 

 

Like all medicines, this medicine can cause side effects, although not everybody gets them. 

 

Some side effects could be serious.  

 

Tell your doctor straight away if you notice any of the following side effects (also section 2 What 

you need to know before you take Lorviqua). Your doctor may lower your dose, stop your treatment 

for a short time or stop your treatment completely: 

- cough, shortness of breath, chest pain or worsening breathing problems  

- slow pulse, (50 beats per minute or less), feeling tired, dizzy or faint or losing consciousness 

- abdominal (belly) pain, back pain, nausea, vomiting, itching or yellowing of the skin and eyes 

- mental status changes; changes in cognition including confusion, memory loss, reduced ability 

to concentrate; changes in mood including irritability and mood swings; changes in speech 

including difficulty speaking, such as slurred or slow speech; or loss of contact with reality, 

such as believing, seeing or hearing things that are not real  

 

Other side effects of Lorviqua may include: 

 

Very common: may affect more than 1 in 10 people 

- increase in cholesterol and triglycerides (fats in your blood that would be detected during blood 

tests)  

- limb or skin swelling  

- problems with your eyes, such as difficulty seeing out of one or both eyes, double vision, or 

perceived flashes of light 

- problems with the nerves in your arms and legs, such as pain, numbness, unusual sensations like 

burning or pins and needles, difficulty walking, or difficulty with usual activities of daily living 

such as writing  

- increased level of enzymes called lipase and/or amylase in the blood that would be detected 

during blood tests 

- low number of red blood cells known as anaemia that would be detected during blood tests  

- diarrhoea 

- constipation 

- pain in your joints   

- weight gain 

- headache 

- rash 

- muscle pain  

 

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 Lorviqua 

 

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 blister foil and carton after 

“EXP”. The expiry date refers to the last day of that month. 

 

This medicine does not require any special storage conditions. 

 

Do not use this medicine if you notice that the package is damaged or shows signs of tampering. 

 

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


37 

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 Lorviqua contains 

- The active substance is lorlatinib. 

Lorviqua 25 mg: each film-coated tablet (tablet) contains 25 mg lorlatinib. 

Lorviqua 100 mg: each film-coated tablet (tablet) contains 100 mg lorlatinib. 

 

- The other ingredients are:  

Tablet core: microcrystalline cellulose, calcium hydrogen phosphate, sodium starch glycolate, 

magnesium stearate. 

Film-coating: Hypromellose, lactose monohydrate, macrogol, triacetin, titanium dioxide (E171), 

iron oxide black (E172), and iron oxide red (E172).  

 

See Lorviqua contains lactose and Lorviqua contains sodium in section 2. 

 

What Lorviqua looks like and contents of the pack 

Lorviqua 25 mg is supplied as round light pink film-coated tablets, debossed with “Pfizer” on one side 

and “25” and “LLN” on the other side. 

Lorviqua 25 mg is provided in blisters of 10 tablets, which are available in packs containing 90 tablets 

(9 blisters) or 120 tablets (12 blisters).  

 

Lorviqua 100 mg is supplied as oval dark pink film-coated tablets, debossed with “Pfizer” on one side 

and “LLN 100” on the other side. 

Lorviqua 100 mg is provided in blisters of 10 tablets, which are available in packs containing 

30 tablets (3 blisters).  

 

Not all pack sizes may be marketed. 

 

Marketing Authorisation Holder  

Pfizer Europe MA EEIG 

Boulevard de la Plaine 17 

1050 Bruxelles 

Belgium  

 

Manufacturer 

Pfizer Manufacturing Deutschland GmbH 

Betriebsstӓtte Freiburg 

Mooswaldallee 1 

79090 Freiburg 

Germany 

 

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

Authorisation Holder: 

  

Belgique/België/Belgien 

Pfizer S.A. / N.V. 

Tél/Tel: +32 (0)2 554 62 11 

Lietuva 

Pfizer Luxembourg SARL filialas Lietuvoje 

Tel: +370 52 51 4000 

 

България 

Пфайзер Люксембург САРЛ, Клон България 

Тел: +359 2 970 4333 

Luxembourg/Luxemburg 

Pfizer S.A. 

Tél/Tel: +32 (0)2 554 62 11 

 



38 

Česká republika 

Pfizer, spol. s r.o. 

Tel: +420 283 004 111 

Magyarország 

Pfizer Kft. 

Tel: +36-1-488-37-00 

 

Danmark 

Pfizer ApS 

Tlf: +45 44 20 11 00 

 

Malta 

Vivian Corporation Ltd. 

Tel: +35621 344610 

Deutschland 

Pfizer Pharma GmbH 

Tel: +49 (0)30 550055 51000 

  

Nederland 

Pfizer BV 

Tel: +31 (0)10 406 43 01 

 

Eesti 

Pfizer Luxembourg SARL Eesti filiaal  

Tel: +372 666 7500 

Norge 

Pfizer AS 

Tlf: +47 67 52 61 00 

 

Ελλάδα 

Pfizer Ελλάς A.E. 

Τηλ: +30 210 6785 800 

Österreich 

Pfizer Corporation Austria Ges.m.b.H. 

Tel: +43 (0)1 521 15-0 

 

España 

Pfizer, S.L. 

Tel: +34 91 490 99 00 

Polska 

Pfizer Polska Sp. z o.o. 

Tel: +48 22 335 61 00 

 

France 

Pfizer  

Tél: +33 (0)1 58 07 34 40 

Portugal 

Laboratórios Pfizer, Lda. 

Tel: +351 21 423 5500 

 

Hrvatska 

Pfizer Croatia d.o.o. 

Tel: +385 1 3908 777 

România 

Pfizer Romania S.R.L. 

Tel: +40 (0) 21 207 28 00 

 

Ireland 

Pfizer Healthcare Ireland 

Tel: 1800 633 363 (toll free) 

+44 (0)1304 616161 

Slovenija 

Pfizer Luxembourg SARL 

Pfizer, podružnica za svetovanje s področja 

farmacevtske dejavnosti, Ljubljana 

Tel: +386 (0)1 52 11 400 

 

Ísland 

Icepharma hf. 

Sími: +354 540 8000 

Slovenská republika 

Pfizer Luxembourg SARL, organizačná zložka  

Tel: +421 2 3355 5500 

 

Italia 

Pfizer S.r.l. 

Tel: +39 06 33 18 21 

Suomi/Finland 

Pfizer Oy 

Puh/Tel: +358 (0)9 43 00 40 

 

Kύπρος 

Pfizer Ελλάς Α.Ε. (Cyprus Branch)  

Τηλ: +357 22 817690 

Sverige  

Pfizer AB 

Tel: +46 (0)8 550 520 00 

 

Latvija 

Pfizer Luxembourg SARL filiāle Latvijā 

Tel: +371 670 35 775 

United Kingdom 

Pfizer Limited 

Tel: +44 (0) 1304 616161 

 

 

This leaflet was last revised in {MM/YYYY}. 

 



39 

This medicine has been given ‘conditional approval’. This means that there is more evidence to come 

about this medicine. 

The European Medicines Agency will review new information on this medicine at least every year and 

this leaflet will be updated as necessary. 

 

Other sources of information  

 

Detailed information on this medicine is available on the European Medicines Agency web site: 

http://www.ema.europa.eu. 

 

https://www.ema.europa.eu/

	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
	E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE CONDITIONAL MARKETING AUTHORISATION
	A. LABELLING
	B. PACKAGE LEAFLET
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{'Title': '2. what you need to know before you take lorviqua', 'Section_Content': "do not take lorviqua - if you are allergic to lorlatinib or any of the other ingredients of this medicine (listed in section 6). - if you are taking any of these medicines: rifampicin (used to treat tuberculosis) carbamazepine, phenytoin (used to treat epilepsy) enzalutamide (used to treat prostate cancer) mitotane (used to treat cancer of the adrenal glands) medicines containing st. john's wort (hypericum perforatum, a herbal preparation) warnings and precautions talk to your doctor before taking lorviqua: - if you have high levels of blood cholesterol or triglycerides - if you have high levels of the enzymes known as amylase or lipase in the blood or a condition such as pancreatitis that can raise the levels of these enzymes - if you have problems with your heart, including heart failure, slow heart rate, or if electrocardiogram (ecg) results show that you have an abnormality of the electrical activity of your heart known as prolonged pr interval or av block. - if you have cough, chest pain, shortness of breath, or worsening of respiratory symptoms or have ever had a lung condition called pneumonitis. if you are not sure, talk to your doctor, pharmacist or nurse before taking lorviqua. tell your doctor immediately if you develop: - heart problems. tell your doctor right away about changes in your heart beat (fast or slow), light-headedness, fainting, dizziness or shortness of breath. these symptoms could be signs of heart problems. your doctor may check for problems with your heart during treatment with lorviqua. if the results are abnormal, your doctor may decide to reduce the dose of lorviqua or stop your treatment. - speech problems, difficulty speaking, including slurred or slow speech. your doctor may investigate further and may decide to reduce your dose of lorviqua or stop your treatment. - mental status changes, mood or memory problems, such as change in your mood (including depression, euphoria and mood swings), irritability, aggression, agitation, anxiety or a change in your personality and episodes of confusion or loss of contact with reality, such as believing, seeing or hearing things that are not real. your doctor may investigate further and may decide to reduce your dose of lorviqua or stop your treatment. - pain in the back or abdomen (belly), yellowing of the skin and eyes (jaundice), nausea or vomiting. these symptoms could be signs of pancreatitis. your doctor may investigate further and may decide to reduce the dose of lorviqua. - cough, chest pain, or a worsening of existing respiratory symptoms. your doctor may investigate further and treat you with other medicines such as antibiotics and steroids. your doctor may decide to reduce your dose of lorviqua or stop your treatment. your doctor may do further assessments and may decide to reduce the dose of lorviqua or stop your treatment if you develop: - liver problems. tell your doctor right away if you feel more tired than usual, your skin and whites of your eyes turn yellow, your urine turns dark or brown (tea colour), you have nausea, vomiting, or decreased appetite, you have pain on the right side of your stomach, you have itching, or if you bruise more easily than usual. your doctor may do blood tests to check your liver function. see possible side effects in section 4 for more information. children and adolescents this medicine is only indicated in adults and it is not to be given to children and adolescents. tests and checks you will have blood tests before you start treatment and during your treatment. these tests are to check the level of cholesterol, triglycerides and the enzymes amylase or lipase in your blood before you start treatment with lorviqua and regularly during treatment. other medicines and lorviqua tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines, including herbal medicines and medicines obtained over the counter. this is because lorviqua can affect the way some other medicines work. also some medicines can affect the way lorviqua works. you must not take lorviqua with certain medicines. these are listed under do not take lorviqua, at the start of section 2. in particular tell your doctor, pharmacist or nurse if you are taking any of the following medicines: - boceprevir a medicine used to treat hepatitis c. - buproprion a medicine used to treat depression or to help people quit smoking. - dihydroergotamine, ergotamine medicines used to treat migraine headaches. - efavirenz, cobicistat, ritonavir, paritaprevir in combination with ritonavir and ombitasvir and/or dasabuvir, and ritonavir in combination with either elvitegravir, indinavir, lopinavir or tipranavir medicines used to treat aids/hiv. - ketoconazole, itraconazole, voriconazole, posaconazole medicines used to treat fungal infections. also troleandomycin, a medicine used to treat certain types of bacterial infections. - quinidine a medicine used to treat irregular heartbeat and other heart problems. - pimozide a medicine used to treat mental health problems. - alfentanil and fentanyl medicines used to treat severe pain. - ciclosporin, sirolimus, and tacrolimus medicines used in organ transplantation to prevent organ rejection. lorviqua with food and drink you must not drink grapefruit juice or eat grapefruit while on treatment with lorviqua as they may change the amount of lorviqua in your body. pregnancy, breast-feeding and fertility - contraception information for women you should not become pregnant while taking this medicine. if you are able to have children, you must use highly effective contraception (for example, double-barrier contraception such as condom and diaphragm) while on treatment and for at least 5 weeks after stopping treatment. lorlatinib may reduce the effectiveness of hormonal contraceptive methods (for example, birth control pill); therefore, hormonal contraceptives may not be considered highly effective. if hormonal contraception is unavoidable it must be used in combination with a condom. talk to your doctor about the right methods of contraception for you and your partner. - contraception information for men you should not father children during treatment with lorviqua because this medicine could harm the baby. if there is any possibility that you may father a child while taking this medicine, you must use a condom during treatment, and for at least 14 weeks after completing therapy. talk to your doctor about the right methods of contraception for you and your partner. - pregnancy do not take lorviqua if you are pregnant. this is because it may harm your baby. if your male partner is being treated with lorviqua, he must use a condom during treatment and for at least 14 weeks after completing therapy. if you become pregnant when taking the medicine or during the 5 weeks after taking your last dose, tell your doctor straight away. - 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{'Title': '3. how to take lorviqua', '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. - the recommended dose is one tablet of 100 mg taken by mouth once daily. - take the dose at about the same time each day. - you can take the tablets with food or between meals always avoiding grapefruit and grapefruit juice. - swallow the tablets whole and do not crush, chew or dissolve the tablets. - sometimes your doctor may lower your dose, stop your treatment for a short time or stop your treatment completely if you feel unwell. if you vomit after taking lorviqua if you vomit after taking a dose of lorviqua, do not take an extra dose, just take your next dose at the usual time. if you take more lorviqua than you should if you accidentally take too many tablets, tell your doctor, pharmacist or nurse right away. you may require medical attention. if you forget to take lorviqua what to do if you forget to take a tablet depends on how long it is until your next dose. - if your next dose is in 4 hours or more, take the missed tablet as soon as you remember. then take the next tablet at the usual time. - if your next dose is in less than 4 hours away, skip the missed tablet. then take the next tablet at the usual time. do not take a double dose to make up for a forgotten dose. if you stop taking lorviqua it is important to take lorviqua every day, for as long as your doctor asks you to. if you are not able to take the medicine as your doctor has prescribed, or you feel you do not need it anymore, speak with your doctor right away. if you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.', 'Entity_Recognition': [{'Text': 'lorviqua', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': '100', 'Type': 'NUMBER', 'BeginOffset': 189, 'EndOffset': 192}, {'Id': 0, 'BeginOffset': 205, 'EndOffset': 210, 'Score': 0.3290887475013733, 'Text': 'mouth', 'Category': 'ANATOMY', 'Type': 'SYSTEM_ORGAN_SITE', 'Traits': []}, {'Text': 'swallow', 'Type': 'TREATMENT', 'BeginOffset': 377, 'EndOffset': 384}, {'Text': 'your treatment', 'Type': 'TREATMENT', 'BeginOffset': 501, 'EndOffset': 515}, {'Text': 'your treatment', 'Type': 'TREATMENT', 'BeginOffset': 541, 'EndOffset': 555}, {'Id': 12, 'BeginOffset': 574, 'EndOffset': 585, 'Score': 0.4878641366958618, 'Text': 'feel unwell', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.9128112196922302}]}, {'Id': 13, 'BeginOffset': 594, 'EndOffset': 599, 'Score': 0.907507598400116, 'Text': 'vomit', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.6465770602226257}]}, {'Id': 5, 'BeginOffset': 613, 'EndOffset': 621, 'Score': 0.9676620364189148, 'Text': 'lorviqua', 'Category': 'MEDICATION', 'Type': 'BRAND_NAME', 'Traits': []}, {'Id': 14, 'BeginOffset': 629, 'EndOffset': 634, 'Score': 0.8221256136894226, 'Text': 'vomit', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.4305436611175537}]}, {'Text': 'a dose of lorviqua', 'Type': 'TREATMENT', 'BeginOffset': 648, 'EndOffset': 666}, {'Text': 'an extra dose', 'Type': 'TREATMENT', 'BeginOffset': 680, 'EndOffset': 693}, {'Id': 7, 'BeginOffset': 756, 'EndOffset': 764, 'Score': 0.8918910622596741, 'Text': 'lorviqua', 'Category': 'MEDICATION', 'Type': 'BRAND_NAME', 'Traits': []}, {'Text': 'medical attention', 'Type': 'TREATMENT', 'BeginOffset': 890, 'EndOffset': 907}, {'Id': 8, 'BeginOffset': 931, 'EndOffset': 939, 'Score': 0.9493564963340759, 'Text': 'lorviqua', 'Category': 'MEDICATION', 'Type': 'BRAND_NAME', 'Traits': []}, {'Text': '4', 'Type': 'NUMBER', 'BeginOffset': 1056, 'EndOffset': 1057}, {'Text': '4', 'Type': 'NUMBER', 'BeginOffset': 1202, 'EndOffset': 1203}, {'Text': 'a double dose', 'Type': 'TREATMENT', 'BeginOffset': 1297, 'EndOffset': 1310}, {'Id': 9, 'BeginOffset': 1363, 'EndOffset': 1371, 'Score': 0.98197340965271, 'Text': 'lorviqua', 'Category': 'MEDICATION', 'Type': 'BRAND_NAME', 'Traits': [{'Name': 'NEGATION', 'Score': 0.5217058062553406}], 'Attributes': [{'Type': 'FREQUENCY', 'Score': 0.9022073745727539, 'RelationshipScore': 0.8927069902420044, 'RelationshipType': 'FREQUENCY', 'Id': 11, 'BeginOffset': 1405, 'EndOffset': 1414, 'Text': 'every day', 'Category': 'MEDICATION', 'Traits': []}]}, {'Id': 10, 'BeginOffset': 1396, 'EndOffset': 1404, 'Score': 0.9914843440055847, 'Text': 'lorviqua', 'Category': 'MEDICATION', 'Type': 'BRAND_NAME', 'Traits': [], 'Attributes': [{'Type': 'FREQUENCY', 'Score': 0.9022073745727539, 'RelationshipScore': 0.9999921321868896, 'RelationshipType': 'FREQUENCY', 'Id': 11, 'BeginOffset': 1405, 'EndOffset': 1414, 'Text': 'every day', 'Category': 'MEDICATION', 'Traits': []}]}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 1651, 'EndOffset': 1664}]}
{'Title': '4. possible side effects', 'Section_Content': 'like all medicines, this medicine can cause side effects, although not everybody gets them. some side effects could be serious. tell your doctor straight away if you notice any of the following side effects (also section 2 what you need to know before you take lorviqua). your doctor may lower your dose, stop your treatment for a short time or stop your treatment completely: - cough, shortness of breath, chest pain or worsening breathing problems - slow pulse, (50 beats per minute or less), feeling tired, dizzy or faint or losing consciousness - abdominal (belly) pain, back pain, nausea, vomiting, itching or yellowing of the skin and eyes - mental status changes; changes in cognition including confusion, memory loss, reduced ability to concentrate; changes in mood including irritability and mood swings; changes in speech including difficulty speaking, such as slurred or slow speech; or loss of contact with reality, such as believing, seeing or hearing things that are not real other side effects of lorviqua may include: very common: may affect more than 1 in 10 people - increase in cholesterol and triglycerides (fats in your blood that would be detected during blood tests) - limb or skin swelling - problems with your eyes, such as difficulty seeing out of one or both eyes, double vision, or perceived flashes of light - problems with the nerves in your arms and legs, such as pain, numbness, unusual sensations like burning or pins and needles, difficulty walking, or difficulty with usual activities of daily living such as writing - increased level of enzymes called lipase and/or amylase in the blood that would be detected during blood tests - low number of red blood cells known as anaemia that would be detected during blood tests - diarrhoea - constipation - pain in your joints - weight gain - headache - rash - muscle pain reporting of side effects if you get any side effects, talk to your doctor, 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{'Title': '5. how to store lorviqua', '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 blister foil and carton after "exp". the expiry date refers to the last day of that month. this medicine does not require any special storage conditions. do not use this medicine if you notice that the package is damaged or shows signs of tampering. 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': None}
{'Title': '6. contents of the pack and other information', 'Section_Content': 'what lorviqua contains - the active substance is lorlatinib. lorviqua 25 mg: each film-coated tablet (tablet) contains 25 mg lorlatinib. lorviqua 100 mg: each film-coated tablet (tablet) contains 100 mg lorlatinib. - the other ingredients are: tablet core: microcrystalline cellulose, calcium hydrogen phosphate, sodium starch glycolate, magnesium stearate. film-coating: hypromellose, lactose monohydrate, macrogol, triacetin, titanium dioxide (e171), iron oxide black (e172), and iron oxide red (e172). see lorviqua contains lactose and lorviqua contains sodium in section 2. what lorviqua looks like and contents of the pack lorviqua 25 mg is supplied as round light pink film-coated tablets, debossed with "pfizer" on one side and "25" and "lln" on the other side. lorviqua 25 mg is provided in blisters of 10 tablets, which are available in packs containing 90 tablets (9 blisters) or 120 tablets (12 blisters). lorviqua 100 mg is supplied as oval dark pink film-coated tablets, debossed with "pfizer" on one side and "lln 100" on the other side. lorviqua 100 mg is provided in blisters of 10 tablets, which are available in packs containing 30 tablets (3 blisters). not all pack sizes may be marketed.', 'Entity_Recognition': [{'Text': 'lorviqua', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 0, 'BeginOffset': 49, 'EndOffset': 59, 'Score': 0.9801914691925049, 'Text': 'lorlatinib', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [], 'Attributes': [{'Type': 'STRENGTH', 'Score': 0.8411228060722351, 'RelationshipScore': 0.9893088340759277, 'RelationshipType': 'STRENGTH', 'Id': 2, 'BeginOffset': 70, 'EndOffset': 75, 'Text': '25 mg', 'Category': 'MEDICATION', 'Traits': []}, {'Type': 'FORM', 'Score': 0.3119533956050873, 'RelationshipScore': 0.9991616010665894, 'RelationshipType': 'FORM', 'Id': 3, 'BeginOffset': 77, 'EndOffset': 86, 'Text': 'each film', 'Category': 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