Zuellig Pharma
Concise Prescribing Info
Adult patients w/ anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) whose disease has progressed after alectinib or ceritinib as 1st ALK tyrosine kinase inhibitors (TKI) therapy; or crizotinib & at least 1 other ALK TKI.
Dosage/Direction for Use
100 mg once daily. 1st dose reduction: 75 mg once daily. 2nd dose reduction: 50 mg once daily. Concomitant use w/ strong CYP3A inhibitor Initially 75 mg once daily.
May be taken with or without food: Take at the same time each day. Swallow whole, do not chew/crush/split.
Hypersensitivity. Concomitant use of strong CYP3A inducers.
Special Precautions
Hyperlipidemia; CNS effects; AV block; decreased left ventricular ejection fraction (LVEF); increased lipase & amylase; pneumonitis; HTN; hyperglycemia. Monitor serum cholesterol, fasting serum glucose & triglycerides prior to initiation; 2, 4 & 8 wk after initiating & periodically thereafter; cardiac monitoring including LVEF assessment at baseline & during treatment; lipase & amylase elevations prior to therapy & regularly thereafter. Control BP prior to initiation. Not to be used concomitantly w/ any strong CYP3A inducers. May affect ability to drive & use machines. Severe renal impairment. Not recommended in moderate to severe hepatic impairment. Women of childbearing potential should use effective contraception during & for at least 21 days after last dose. May compromise male fertility. Not recommended during pregnancy or for women of childbearing potential not using contraception. Not be used during lactation. Childn. Elderly ≥65 yr.
Adverse Reactions
Anaemia; hypercholesterolaemia, hypertriglyceridaemia; mood & cognitive effects, peripheral neuropathy, headache; vision disorder; diarrhoea, nausea, constipation; rash; arthralgia, myalgia; oedema, fatigue; increased wt, lipase & amylase. Psychotic effects, mental status changes; speech effects; pneumonitis.
Drug Interactions
Increased plasma conc w/ strong CYP3A inhibitors eg, boceprevir, cobicistat, conivaptan, itraconazole, ketoconazole, posaconazole, telaprevir, troleandomycin, voriconazole, ritonavir, paritaprevir w/ ritonavir & ombitasvir &/or dasabuvir, ritonavir w/ danoprevir, elvitegravir, indinavir, lopinavir, saquinavir, tipranavir; grapefruit. Decreased plasma conc w/ strong CYP3A inducers eg, rifampin, carbamazepine, enzalutamide, mitotane, phenytoin, St. John's wort; moderate CYP3A4 inducers. Reduced plasma conc of CYP3A substrates w/ narrow therapeutic indices eg, hormonal contraceptives, alfentanil, cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus; P-gp substrates w/ narrow therapeutic index eg, digoxin.
ATC Classification
L01ED05 - lorlatinib ; Belongs to the class of anaplastic lymphoma kinase (ALK) inhibitors. Used in the treatment of cancer.
Lorviqua FC tab 100 mg
3 × 10's
Lorviqua FC tab 25 mg
3 × 10's
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