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Monitor liver function tests including ALT, AST, and total bilirubin every 2 weeks during the first 3 months of treatment, then once a month and as clinically indicated, with more frequent testing in patients who develop transaminase and bilirubin elevations. Based on the severity of the adverse drug reaction, withhold Alectinib and resume at a reduced dose or permanently discontinue Alectinib as described in Table 3.
Promptly investigate for ILD/pneumonitis in any patient who presents with worsening of respiratory symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, and fever). Immediately withhold Alectinib treatment in patients diagnosed with ILD/pneumonitis and permanently discontinue Alectinib if no other potential causes of ILD/pneumonitis have been identified.
Permanently discontinue Alectinib for Grade 4 renal toxicity. Withhold Alectinib for Grade 3 renal toxicity until recovery to less than or equal to 1.5 times ULN, then resume at reduced dose.
Monitor heart rate and blood pressure regularly. For asymptomatic bradycardia dose modification is not required. For symptomatic bradycardia that is not life-threatening, withhold Alectinib until recovery to asymptomatic bradycardia or to a heart rate ≥ 60 bpm and evaluate concomitant medications known to cause bradycardia, as well as anti-hypertensive medications. If bradycardia is attributable to a concomitant medication, resume Alectinib at a reduced dose (see Table 2) upon recovery to asymptomatic bradycardia or to a heart rate of ≥ 60 bpm, with frequent monitoring as clinically indicated.
Permanently discontinue Alectinib in cases of life-threatening bradycardia if no contributing concomitant medication is identified. Permanently discontinue Alectinib for recurrence of life-threatening bradycardia.
from FDA,2024.04
