Alecensa

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. Advise to use effective contraception during and for 5 weeks (females of reproductive potential) or 3 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 week after the last dose).