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Lorbrexen 100
Everest Pharmaceuticals Ltd.
Generic: Lorlatinib
Medicine Overview of Lorbrexen 100mg Tablet
বাংলা
English
Indication
Non-small Cell Lung Cancer
Adult Dose
Non-small Cell Lung Cancer
Indications
Indicated for patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on the following
Crizotinib and at least 1 other ALK inhibitor, OR
Alectinib or ceritinib as first ALK inhibitor therapy
100 mg PO qDay with or without food
Continue until disease progression or unacceptable toxicity
Hepatic impairment
Mild (total bilirubin ?ULN with AST >ULN or total bilirubin >1-1.5x ULN with any AST): No dose adjustment necessary
Moderate or severe: Recommended dose not established
Renal Dose
Renal impairment
Mild or moderate (CrCl 30-89 mL/min): No dosage adjustment necessary
Severe (CrCl <30 mL/min): Recommended dose not established
Contraindication
Coadministration with strong CYP3A inducers
Mode of Action
ALK/ROS1 tyrosine kinase inhibitor
ALK and ROS1 kinases promote tumor progression in ALK/ROS1 positive lung cancer; lorlatinib binds to and inhibits both kinases, which leads to a disruption of the ALK- and ROS1-mediated signaling; this disruption can subsequently inhibit tumor cell growth in ALK- and ROS1-overexpressing tumor cells
Precaution
Severe hepatotoxicity occurred in healthy subjects receiving lorlatinib with rifampin, a strong CYP3A inducer; consider discontinuing lorlatinib or CYP3A inducer for persistent Grade ≥2 hepatotoxicity (see Contraindications)
CNS effects (eg, seizures, hallucinations, changes in cognitive function, mood [including suicidal ideation]) may occur Increased serum cholesterol and triglycerides may occur; initiate or increase dose of lipid-lowering agents in patients with hyperlipidemia; monitor serum cholesterol and triglycerides
PR interval prolongation and AV block reported; monitor ECG before initiating treatment and periodically thereafter
Severe or life-threatening pulmonary adverse reactions consistent with ILD/pneumonitis can occur
Side Effect
>10% Hypercholesterolemia (96%) Hypertriglyceridemia (90%) Edema (57%) Hyperglycemia (52%) Anemia (52%) Peripheral neuropathy (47%) Increased AST (37%) Hypoalbuminemia (33%) Increased ALT (28%) Cognitive effects (27%) Dyspnea (27%) Fatigue (26%) Weight gain (24%) Increased lipase (24%) Increased alkaline phosphatase (24%) Thrombocytopenia (23%) Arthralgia (23%) Mood effects (23%) Diarrhea (22%) Increased amylase (22%) Lymphopenia (22%) Hyperkalemia (21%) Hypomagnesemia (21%) Headache (18%) Cough (18%) Nausea (18%) Myalgia (17%) Dizziness (16%) Vision disorder (15%) Constipation (15%) Rash (14%) Back pain (13%) Pain in extremity (13%) Vomiting (12%) Speech effects (12%) Pyrexia (12%) Upper respiratory tract infection (12%) Grades 3 or 4 Hypercholesterolemia (18%) Hypertriglyceridemia...
... Show morePregnancy Category Note
Pregnancy Based on findings from animal studies and its mechanism of action, embryo-fetal harm may occur when administered to a pregnant woman No available data on use in pregnant women Advise pregnant women of the potential risk to fetus Verify pregnancy status in females of reproductive potential before initiating treatment Animal data Administration of lorlatinib to pregnant rats and rabbits by oral gavage during organogenesis resulted in malformations, increased postimplantation loss, and abortion at maternal exposures that were equal to or less than the human exposure at 100 mg qDay Contraception Female patients of reproductive potential: Use effective nonhormonal contraception...
... Show moreInteraction
CYP3A4 inducers
Coadministration with strong CYP3A inducers decrease lorlatinib plasma concentrations
Effect of moderate CYP3A inducer on lorlatinib plasma concentrations not studied; if coadministration unavoidable, monitor ALT, AST, and bilirubin
CYP3A4 inhibitors
Coadministration with strong CYP3A inhibitors increased lorlatinib plasma concentrations
CYP3A substrates
Coadministration with CYP3A substrates decreases concentration of CYP3A substrates, which may reduce the efficacy of these substrates
Avoid use with CYP3A substrates with narrow therapeutic index; if coadministration unavoidable, increase dose of CYP3A substrate in accordance to prescribing information
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