ILD/pneumonitis of any severity grade

Immediately interrupt and permanently discontinue ALECENSA if no other potential causes of ILD/pneumonitis have been identified

ALT or AST elevation of >5 times ULN with total bilirubin ≤2 times ULN

Temporarily withhold until recovery to baseline or ≤3 times ULN, then resume at reduced dose (see table above)

ALT or AST elevation of >3 times ULN with total bilirubin elevation >2 times ULN in the absence of cholestasis or haemolysis

Permanently discontinue ALECENSA

Bradycardia^† Grade 2 or 3 (symptomatic, may be severe and medically significant, medical intervention indicated)

Temporarily withhold ALECENSA until recovery to Grade ≤1 (asymptomatic) bradycardia or to a heart rate of ≥60 bpm. Evaluate concomitant medicinal products known to cause bradycardia, as well as anti-hypertensive medicinal products. If a contributing concomitant medicinal product is identified and discontinued, or its dose is adjusted, resume ALECENSA at previous dose upon recovery to Grade ≤1 (asymptomatic) bradycardia or to a heart rate ≥60 bpm. If no contributing concomitant medicinal product is identified, or if contributing concomitant medicinal products are not discontinued or dose modified, resume ALECENSA at reduced dose (see table above) upon recovery to Grade ≤1 (asymptomatic) bradycardia or to a heart rate of ≥60 bpm

Bradycardia^† Grade 4 (life-threatening consequences, urgent intervention indicated)

Permanently discontinue ALECENSA if no contributing concomitant medicinal product is identified. If a contributing concomitant medicinal product is identified and discontinued, or its dose is adjusted, resume ALECENSA at reduced dose (see table above) upon recovery to Grade ≤1 (asymptomatic) bradycardia or to a heart rate of ≥60 bpm, with frequent monitoring as clinically indicated. Permanently discontinue ALECENSA in case of recurrence

CPK elevation >5 times the ULN

Temporarily withhold ALECENSA until recovery to baseline or to ≤2.5 times the ULN, then resume ALECENSA at same dose

CPK elevation >10 times the ULN or second occurrence of CPK elevation of >5 times 
the ULN

Temporarily withhold ALECENSA until recovery to baseline or to ≤2.5 times the ULN, then resume ALECENSA at reduced dose (see table above)