Alecensa Generic Name & Formulations
Legal Class
Rx
General Description
Alectinib 150mg; caps.
Pharmacological Class
Kinase inhibitor.
How Supplied
Caps—240
Manufacturer
Generic Availability
NO
Alecensa Indications
Indications
Treatment of patients with anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.
Alecensa Dosage and Administration
Adult
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 for adverse reactions: see full labeling.
Children
Not established.
Alecensa Contraindications
Not Applicable
Alecensa Boxed Warnings
Not Applicable
Alecensa Warnings/Precautions
Warnings/Precautions
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. Withhold if hemolytic anemia is suspected; consider resuming at reduced dose upon resolution or permanently discontinue if confirmed. 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).
Alecensa Pharmacokinetics
See Literature
Alecensa Interactions
Interactions
Increased bradycardia with concomitant antihypertensives or other drugs known to cause bradycardia.
Alecensa Adverse Reactions
Adverse Reactions
Fatigue, constipation, edema, myalgia, anemia; hepatotoxicity, ILD/pneumonitis, renal impairment, bradycardia, CPK elevation, hemolytic anemia.
Alecensa Clinical Trials
See Literature
Alecensa Note
Not Applicable
Alecensa Patient Counseling
See Literature
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