Usual Adult Dose for Non-Small Cell Lung Cancer

600 mg orally 2 times a day with food until disease progression or unacceptable toxicity

Comments:

• Select patients for the treatment of metastatic NSCLC based on the presence of ALK positivity in tumor tissue or plasma specimens.
• If ALK rearrangements are not detected in a plasma specimen, test tumor tissue if possible.

Use: For the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-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 dysfunction: No adjustment recommended.
• Severe hepatic dysfunction (Child-Pugh C): 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.

HEMOLYTIC ANEMIA:

• If hemolytic anemia is suspected: Withhold therapy
• Upon resolution: Resume at reduced dose or permanently discontinue.

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.

Frequently asked questions

• What is the mechanism of action for Alecensa (alectinib)?
• What is Alecensa used to treat?