Lorviqua

Lorviqua

lorlatinib

Manufacturer:

Pfizer

Distributor:

Pfizer
Concise Prescribing Info
Contents
Lorlatinib
Indications/Uses
Anaplastic lymphoma kinase (ALK) +ve advanced NSCLC in adult patients.
Dosage/Direction for Use
100 mg once daily continuously. 1st dose reduction: 75 mg once daily; 2nd dose reduction: 50 mg once daily. Patients w/ severe renal impairment (absolute eGFR <30 mL/min) Initially 75 mg once daily.
Administration
May be taken with or without food: Swallow whole, do not chew/crush/split.
Contraindications
Potential for serious hepatotoxicity w/ concomitant use w/ CYP3A inducers.
Special Precautions
Increases serum cholesterol & triglycerides. Monitor serum cholesterol & triglycerides before initiation, 2, 4, & 8 wks after initiating, & periodically thereafter. CNS effects including psychotic effects, changes in cognitive function, mood, speech, & mental status changes. May cause PR interval prolongation & AV block; monitor ECG prior to initiation & mthly thereafter, particularly in patients w/ predisposing conditions to the occurrence of clinically significant cardiac events. Pneumonitis. BP should be controlled prior to initiation; monitor after 2 wks & at least mthly thereafter during treatment. Assess fast serum glucose prior to initiation & monitored periodically thereafter. Moderate influence on the ability to drive & use machines. Not recommended in patients w/ moderate to severe hepatic impairment. Severe renal impairment. Women of childbearing potential should avoid becoming pregnant during treatment; use of non-hormonal contraceptive is required. Male patients w/ female partners of reproductive potential should use effective contraception including a condom & male patients w/ pregnant partners should use condoms during treatment & for at least 97 days after the final dose. Do not use during breastfeeding. Childn.
Adverse Reactions
Hypercholesterolemia, hypertriglyceridemia, hyperglycemia; mood effects, psychotic effects, mental status changes; cognitive effects, peripheral neuropathy, speech effects; vision disorder, HTN; pneumonitis; diarrhea, constipation; arthralgia; edema, fatigue; increased wt.
Drug Interactions
May increase plasma conc w/ strong CYP3A inhibitors (eg, boceprevir, cobicistat, conivaptan, itraconazole, ketoconazole, posaconazole, telaprevir, troleandomycin, voriconazole, ritonavir, paritaprevir in combination w/ ritonavir & ombitasvir &/or dasabuvir, & ritonavir in combination w/ either danoprevir, elvitegravir, indinavir, lopinavir, saquinavir, or tipranavir), grapefruit products. Increased LFT (AST & ALT) w/ CYP3A inducers. May decrease plasma conc w/ strong CYP3A inducers (eg, rifampin, carbamazepine, enzalutamide, mitotane, phenytoin, & St. John's wort). May reduce the conc of CYP3A substrates w/ narrow therapeutic indices, including hormonal contraceptives, alfentanil, cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, & tacrolimus. May reduce plasma conc of moderate P-gp substrates w/ narrow therapeutic index (eg, digoxin).
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01ED05 - lorlatinib ; Belongs to the class of anaplastic lymphoma kinase (ALK) inhibitors. Used in the treatment of cancer.
Presentation/Packing
Form
Lorviqua FC tab 100 mg
Packing/Price
30's
Form
Lorviqua FC tab 25 mg
Packing/Price
90's
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