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Alectinib Dosage

Medically reviewed by Drugs.com. Last updated on Sep 7, 2020.

Applies to the following strengths: 150 mg

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 Adjustments

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.

BRADYCARDIA:
-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.

Precautions

CONTRAINDICATIONS:
-None

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration Advice:
-Take this drug with food.
-Swallow capsules whole; do not open or dissolve.

Storage Requirements:
-Store in original container if possible; protect from light and moisture; do not store above 30C (86F).

Monitoring:
-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)

Patient Advice:
-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.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Frequently Asked Questions