Treatment options for people with ALK+ mNSCLC include therapies called ALK inhibitors that target abnormal ALK proteins. ALK inhibitors work by blocking the abnormal ALK protein responsible for the growth and spread of ALK+ mNSCLC.
ALECENSA is an ALK inhibitor that helps treat ALK+ metastatic NSCLC.
ALECENSA is approved to treat people with non-small cell lung cancer that has spread to other parts of the body and whose type of NSCLC is caused by an abnormal anaplastic lymphoma kinase gene (ALK+ mNSCLC). To be eligible to take ALECENSA, a diagnostic test must confirm that your NSCLC is caused by abnormal ALK proteins. It is not known if ALECENSA is safe and effective in children.
If you and your doctor decide that ALECENSA is right for you, treatment goals may be set to see how your ALK+ mNSCLC tumors respond to treatment with ALECENSA.
Criteria | ALECENSA dose modification |
---|---|
ALT or AST elevation of >5X ULN with total bilirubin ≤2X ULN | Temporarily withhold until recovery to baseline or to ≤3X ULN, then resume at reduced dose. See dose reduction schedule. |
ALT or AST elevation >3X ULN with total bilirubin elevation >2X ULN in the absence of cholestasis or hemolysis | Permanently discontinue ALECENSA. |
Total bilirubin elevation >3X ULN | Temporarily withhold until recovery to baseline or to ≤1.5X ULN, then resume at reduced dose. See dose reduction schedule. |
Any grade treatment-related ILD/pneumonitis | Permanently discontinue ALECENSA. |
Grade 3 renal impairment | Temporarily withhold until serum creatinine recovers to ≤1.5X ULN, then resume at reduced dose. See dose reduction schedule. |
Grade 4 renal impairment | Permanently discontinue ALECENSA. |
Symptomatic bradycardia | Withhold ALECENSA until recovery to asymptomatic bradycardia or to a heart rate of ≥60 bpm. If contributing concomitant medication is identified and discontinued, or its dose is adjusted, resume ALECENSA at previous dose upon recovery to asymptomatic bradycardia or to a heart rate of ≥60 bpm. If no contributing concomitant medication is identified, or if contributing concomitant medications are not discontinued or dose modified, resume ALECENSA at reduced dose upon recovery to asymptomatic bradycardia or to a heart rate of ≥60 bpm. See dose reduction schedule. |
Bradycardiaa (life-threatening consequences, urgent intervention indicated) | Permanently discontinue ALECENSA if no contributing concomitant medication is identified. If contributing concomitant medication is identified and discontinued, or its dose is adjusted, resume ALECENSA at reduced dose upon recovery to asymptomatic bradycardia or to a heart rate of ≥60 bpm, with frequent monitoring as clinically indicated. Permanently discontinue ALECENSA in case of recurrence. See dose reduction schedule. |
CPK elevation of >5X ULN | Temporarily withhold until recovery to baseline or to ≤2.5X ULN, then resume at same dose. |
CPK elevation >10X ULN or second occurrence of CPK elevation of >5X ULN | Temporarily withhold until recovery to baseline or to ≤2.5X ULN, then resume at reduced dose. See dose reduction schedule. |
Hemolytic anemia | Withhold ALECENSA if hemolytic anemia is suspected. Upon resolution, resume at reduced dose or permanently discontinue. See dose reduction schedule. |
aHeart rate <60 bpm.
ALT=alanine transaminase; AST=aspartate transaminase; bpm=beats per minute; CPK=creatine phosphokinase; ILD=interstitial lung disease; ULN=upper limit of normal.
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