Medically reviewed by Drugs.com. Last updated on Sep 7, 2020.
Applies to the following strengths: 150 mg
Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Non-Small Cell Lung Cancer
600 mg orally 2 times a day with food until disease progression or unacceptable toxicity
Use: For anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an approved test
Renal Dose Adjustments
-Mild (CrCl 60 to less than 90 mL/min) or moderate (30 to less than 60 mL/min renal impairment: No adjustment recommended.
-Severe renal impairment (CrCl less than 30 mL/min) or end-stage renal disease: Data not available
-Grade 3 renal impairment: Temporarily withhold therapy until recovery to baseline or to 1.5 x ULN or less, then resume at reduced dose.
-Grade 4 renal impairment: Permanently discontinue therapy.
Liver Dose Adjustments
-Mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment: No adjustment recommended.
-Moderate to severe hepatic impairment: Reduce dose to 450 mg orally 2 times a day.
-ALT or AST elevation of greater than 5 times the upper limit of normal (ULN) with total bilirubin 2 x ULN or less: Temporarily withhold therapy until recovery to baseline or to 3 x ULN or less, then resume at reduced dose.
-ALT or AST elevation greater than 3 x ULN with total bilirubin elevation greater than 2 x ULN in the absence of cholestasis or hemolysis: Permanently discontinue therapy.
-Total bilirubin elevation greater than 3 x ULN: Temporarily withhold therapy until recovery to baseline or to 1.5 x ULN or less, then resume at reduced dose.
Dose Reduction Schedule for Adverse Reactions:
-Starting dose: 600 mg orally 2 times a day
-First Dose Reduction: 450 mg orally 2 times a day
-Second Dose Reduction: 300 mg orally 2 times a day twice a day
-Discontinue therapy if 300 mg orally 2 times a day is not tolerated.
-Symptomatic: Withhold therapy until recovery to asymptomatic bradycardia or to a heart rate of 60 bpm or above, resume previous dose IF contributing concomitant medication is discontinued/dose modified OR resume at reduced dose IF contributing concomitant medication is not identified/not discontinued/not dose modified.
-Heart Rate Less than 60 bpm, life-threatening consequences, urgent intervention needed: Permanently discontinue therapy if no contributing concomitant medication is identified or in case of recurrence. If contributing concomitant medication is identified/discontinued/dose modified, resume at reduced dose upon recovery to asymptomatic bradycardia or to a heart rate of 60 bpm or above with frequent monitoring as clinically indicated. Permanently discontinue therapy in case of recurrence.
ANY GRADE TREATMENT-RELATED INTERSTITIAL LUNG DISEASE (ILD)/PNEUMONITIS: Permanently discontinue therapy.
BLOOD CREATINE PHOSPHOKINASE (CPK) ELEVATION:
-Greater than 5 x ULN: Temporarily withhold therapy until recovery to baseline or to 2.5 x ULN or less, then resume at same dose.
-Greater than 10 x ULN or second occurrence of CPK elevation greater than 5 x ULN: Temporarily withhold therapy until recovery to baseline or to 2.5 x ULN or less, then resume at reduced dose.
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Data not available
-Take this drug with food.
-Swallow capsules whole; do not open or dissolve.
-Store in original container if possible; protect from light and moisture; do not store above 30C (86F).
-Cardiovascular: Monitor heart rate and blood pressure regularly.
-Hepatic: LFTs (every 2 weeks during the first 2 months of therapy, periodically during therapy; more frequent testing in patients who develop transaminase and bilirubin elevations)
-Musculoskeletal: CPK levels (every 2 weeks for the first month of therapy and as clinically indicated in symptomatic patients)
-Avoid sun exposure during therapy and for 7 days after you take the final dose; use broad-spectrum sunscreen and lip balm with SPF 50 or greater to help protect against potential sunburn.
-If you vomit after taking a dose or if you miss a dose, do not take an extra dose unless the next dose is due within 6 hours; take your next dose at the regular time.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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- Drug class: multikinase inhibitors
Other brands: Alecensa