Alectinib

FDA label

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Renal No adjustment for mild-moderate impairment; not studied in severe impairment (CrCl <30 mL/min) or ESRD

Hepatic Mild-moderate (Child-Pugh A/B): no adjustment; severe (Child-Pugh C): 450 mg BID

Instructions

• Swallow capsules whole; do not open or dissolve
• Take with food
• If a dose is missed or vomiting occurs, take the next dose at the scheduled time
• Adjuvant: treat for 2 years or until recurrence/unacceptable toxicity; metastatic: until progression/unacceptable toxicity
• Dose-reduce for adverse reactions: 450 mg BID, then 300 mg BID; discontinue if 300 mg BID not tolerated

Cautions

• Hepatotoxicity — monitor LFTs every 2 weeks for first 3 months, then monthly
• Interstitial lung disease/pneumonitis — withhold and discontinue if confirmed
• Renal impairment (including fatal cases)
• Bradycardia — monitor heart rate and blood pressure
• Severe myalgia and CPK elevation — assess CPK
• Hemolytic anemia
• Embryo-fetal toxicity — effective contraception

Adverse reactions

• Hepatotoxicity, constipation, fatigue, myalgia, edema, rash, cough
• Lab: increased CPK, decreased hemoglobin, increased ALT/AST/bilirubin

Pregnancy Can cause fetal harm (animal embryo-fetal toxicity/abortion). Verify pregnancy status; use effective contraception during and 5 weeks after last dose.

Lactation Do not breastfeed during treatment and for 1 week after the last dose.