Generic Name and Formulations:
Alectinib 150mg; caps.
Indications for ALECENSA:
Treatment of patients with anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.
Swallow whole. Take with food. 600mg twice daily until disease progression or unacceptable toxicity. Severe hepatic impairment (Child-Pugh C): 450mg twice daily. Dose modifications or dose reduction schedule: see full labeling.
Monitor liver function tests (eg, ALT, AST, total bilirubin) every 2 weeks for the first 3 months, then monthly and as clinically indicated; test more frequently if transaminase and bilirubin elevated; withhold, resume at reduced dose, or permanently discontinue based on severity. Evaluate if presence of worsening respiratory symptoms; withhold if ILD/pneumonitis diagnosed; permanently discontinue if no other cause identified. Withhold for Grade 3 renal toxicity until recovery to ≤1.5×ULN, then resume at reduced dose; permanently discontinue if Grade 4 occurs. Monitor HR, BP regularly. If non-life-threatening symptomatic bradycardia occurs, withhold until asymptomatic or HR ≥60bpm; permanently discontinue in case(s) of recurrence or life-threatening bradycardia if no contributing concomitant medication identified. Assess CPK every 2 weeks for the first month and as clinically indicated; withhold, resume, or reduce dose based on severity. Severe hepatic or renal impairment/ESRD. Embryo-fetal toxicity. Pregnancy: avoid. Use effective contraception during and for 1 week (females) or 3 months (males) after final dose. Nursing mothers: not recommended (during and for 1 week after final dose).
Increased bradycardia with concomitant antihypertensives or other drugs known to cause bradycardia.
Fatigue, constipation, edema, myalgia, anemia; hepatotoxicity, ILD/pneumonitis, renal impairment, bradycardia, CPK elevation.
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