ALT or AST elevation of greater than 5 times upper limit   of normal (ULN)   with total bilirubin less than or equal to 2   times ULN

Temporarily withhold until recovery   to baseline or to less   than or equal to 3 times ULN, then resume   at reduced dose as per Table 1.

ALT or AST elevation greater than 3   times ULN with total bilirubin   elevation greater than 2 times ULN in the absence of cholestasis or hemolysis

Permanently discontinue ALYNNI (ALECTRNIB).

Total bilirubin elevation of greater than   3 times ULN

Temporarily   withhold until recovery to baseline or to   less than or equal to 1.5   times ULN, then resume at reduced    dose as per Table 1.

Any grade   treatment-related interstitial lung disease (ILD)/pneumonitis

Permanently discontinue ALYNNI (ALECTRNIB).

Grade 3 renal   impairment

Temporarily withhold until serum creatinine   recovers to

less than or equal to 1.5 times   ULN, then resume at reduced dose.

Grade 4 renal   impairment

Permanently discontinue ALYNNI (ALECTRNIB).

Symptomatic   bradycardia

Withhold ALYNNI   (ALECTRNIB) until recovery to asymptomatic   bradycardia or to a heart rate of 60 bpm or above.

If contributing concomitant medication is identified and

discontinued,   or its dose is adjusted, resume ALYNNI   (ALECTRNIB) at previous dose upon recovery to   asymptomatic bradycardia    or to a heart rate of 60 bpm or above.

If no contributing concomitant medication is identified, or if contributing concomitant medications are not

discontinued or dose   modified, resume ALYNNI (ALECTRNIB) at

reduced dose   (see Table 1) upon recovery to asymptomatic bradycardia or to a heart rate of 60 bpm or above.

Bradycardiab (life-threatening consequences, urgent intervention   indicated)

Permanently discontinue ALYNNI (ALECTRNIB) if no contributing   concomitant medication is identified.

If contributing concomitant medication is identified and

discontinued, or its dose is adjusted,   resume ALYNNI (ALECTRNIB) at   reduced dose (see Table 1) upon recovery to asymptomatic   bradycardia or to a heart rate of 60 bpm or above, with

frequent   monitoring as clinically indicated. Permanently   discontinue ALYNNI (ALECTRNIB) in case of recurrence.

CPK elevation greater than 5 times ULN

Temporarily   withhold until recovery to baseline or to   less  than or equal to 2.5 times   ULN, then resume at same dose.

CPK elevation greater   than 10   times ULN or second

occurrence of CPK elevation of greater than   5 times ULN

Temporarily   withhold until recovery to baseline or to   less than or equal to 2.5 times ULN, then resume at reduced    dose as per Table 1.