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Alectinib Dosage

Applies to the following strength(s): 150 mg

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Non-Small Cell Lung Cancer

600 mg orally twice a day

Duration of Therapy: Until disease progression or unacceptable toxicity

Comments: This drug should be taken with food.

Use: Treatment of patients with anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.

Renal Dose Adjustments

-Mild to Moderate Renal Impairment (CrCl 30 to 89 mL/min): No adjustment recommended.
-Severe Renal Impairment (CrCl less than 30 mL/min) or End-Stage Renal Disease: Data not available.

Liver Dose Adjustments

-Mild Hepatic Impairment (Total bilirubin upper limit of normal [ULN] or less AND AST greater than ULN OR total bilirubin greater than 1.0 to 1.5 times ULN AND any AST): No adjustment recommended.
-Moderate to Severe Hepatic Impairment: Data not available.

DOSE REDUCTION SCHEDULE IF HEPATOTOXICITY DEVELOPS DURING TREATMENT:
-First Dose Reduction: 450 mg orally twice a day
-Second Dose Reduction: 300 mg orally twice a day; Discontinue treatment if this dose not tolerated.

-ALT or AST Elevation Greater than 5 x ULN with Total Bilirubin 2 X ULN or Less: Temporarily withhold treatment 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 treatment.
-Total Bilirubin Elevation Greater than 3 x ULN: Temporarily withhold treatment 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:
-First Dose Reduction: 450 mg orally twice a day
-Second Dose Reduction: 300 mg orally twice a day; Discontinue treatment if this dose not tolerated.

ANY GRADE TREATMENT-RELATED INTERSTITIAL LUNG DISEASE (ILD)/PNEUMONITIS: Permanently discontinue treatment.

BLOOD CREATINE PHOSPHOKINASE (CPK) ELEVATION:
-Greater than 5 x ULN: Temporarily withhold treatment until recovery to baseline or to 2.5 x ULN or less, then resume at previous dose.
-Greater than 10 x ULN or Second Occurrence of CPK Elevation Greater than 5 x ULN: Temporarily withhold treatment until recovery to baseline or to 2.5 x ULN or less, then resume at reduced dose.

BRADYCARDIA:
-Symptomatic: Withhold treatment. Upon 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 treatment 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.

Precautions

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:
-Drug capsules should be swallowed whole and not opened or dissolved.

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

General:
-This drug received accelerated approval based on tumor response rate and duration of response; continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial.
-In the 2 clinical trials that established the safety and efficacy of this drug, the major efficacy outcome was objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1); the ORR ranged from 38% to 48% (all were partial responses).
-This drug and its major active metabolite M4 demonstrated activity against multiple mutant forms of the ALK enzyme, including some mutations identified in NSCLC tumors in patients who have progressed on crizotinib.
-Overdosage: No specific antidote is available; hemodialysis is unlikely to be effective since this drug and M4 are greater than 99% bound to plasma proteins.

Monitoring:
-Cardiovascular: Monitor heart rate and blood pressure regularly.
-Hepatic: LFTs (every 2 weeks during the first 2 months of treatment, periodically during treatment; more frequent testing in patients who develop transaminase and bilirubin elevations)
-Musculoskeletal: CPK levels (every 2 weeks for the first month of treatment and as clinically indicated in symptomatic patients)

Patient Advice:
-Avoid sun exposure during treatment and for 7 days after you take the final dose of this drug; 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; take your next dose at the regular time.

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