Alecensa Dosage

Generic name: ALECTINIB HYDROCHLORIDE 150mg
Dosage form: capsule
Drug class: Multikinase inhibitors

Medically reviewed by Drugs.com. Last updated on Jun 16, 2022.

Patient Selection

Select patients for the treatment of metastatic NSCLC with ALECENSA based on the presence of ALK positivity in tumor tissue or plasma specimens [see Indications and Usage (1) and Clinical Studies (14)]. If ALK rearrangements are not detected in a plasma specimen, test tumor tissue if feasible.

Information on FDA-approved tests for the detection of ALK rearrangements in NSCLC is available at http://www.fda.gov/CompanionDiagnostics.

Dosing and Administration

The recommended dose of ALECENSA is 600 mg orally twice daily [see Clinical Pharmacology (12.3)]. Administer ALECENSA until disease progression or unacceptable toxicity.

The recommended dose of ALECENSA in patients with severe hepatic impairment (Child-Pugh C) is 450 mg orally twice daily [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].

ALECENSA should be taken with food. Do not open or dissolve the contents of the capsule. If a dose of ALECENSA is missed or vomiting occurs after taking a dose of ALECENSA, take the next dose at the scheduled time.

Dose Modifications for Adverse Reactions

The dose reduction schedule for ALECENSA is provided in Table 1.

Table 1: ALECENSA Dose Reduction Schedule
Dose reduction schedule	Dose level
Starting dose	600 mg taken orally twice daily
First dose reduction	450 mg taken orally twice daily
Second dose reduction	300 mg taken orally twice daily

Discontinue if patients are unable to tolerate the 300 mg twice daily dose.

Recommendations for dose modifications of ALECENSA in case of adverse reactions are provided in Table 2.

Table 2: ALECENSA Dose Modifications for Adverse Reactions
Criteria*	ALECENSA Dose Modification
* ALT = alanine transaminase; AST = aspartate transaminase; ULN = upper limit of normal; ILD = interstitial lung disease; CPK = blood creatine phosphokinase † Heart rate less than 60 beats per minute (bpm)
ALT or AST elevation of greater than 5 times upper limit of normal (ULN) with total bilirubin less than or equal to 2 times ULN	Temporarily withhold until recovery to baseline or to less than or equal to 3 times ULN, then resume at reduced dose as per Table 1.
ALT or AST elevation greater than 3 times ULN with total bilirubin elevation greater than 2 times ULN in the absence of cholestasis or hemolysis	Permanently discontinue ALECENSA.
Total bilirubin elevation of greater than 3 times ULN	Temporarily withhold until recovery to baseline or to less than or equal to 1.5 times ULN, then resume at reduced dose as per Table 1.
Any grade treatment-related interstitial lung disease (ILD)/pneumonitis	Permanently discontinue ALECENSA.
Grade 3 renal impairment	Temporarily withhold until serum creatinine recovers to less than or equal to 1.5 times ULN, then resume at reduced dose.
Grade 4 renal impairment	Permanently discontinue ALECENSA.
Symptomatic bradycardia	Withhold ALECENSA until recovery to asymptomatic bradycardia or to a heart rate of 60 bpm or above. 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 or above. If no contributing concomitant medication is identified, or if contributing concomitant medications are not discontinued or dose modified, resume ALECENSA at reduced dose (see Table 1) upon recovery to asymptomatic bradycardia or to a heart rate of 60 bpm or above.
Bradycardia† (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 (see Table 1) upon recovery to asymptomatic bradycardia or to a heart rate of 60 bpm or above, with frequent monitoring as clinically indicated. Permanently discontinue ALECENSA in case of recurrence.
CPK elevation greater than 5 times ULN	Temporarily withhold until recovery to baseline or to less than or equal to 2.5 times ULN, then resume at same dose.
CPK elevation greater than 10 times ULN or second occurrence of CPK elevation of greater than 5 times ULN	Temporarily withhold until recovery to baseline or to less than or equal to 2.5 times ULN, then resume at reduced dose as per Table 1.
Hemolytic Anemia	Withhold ALECENSA if hemolytic anemia is suspected. Upon resolution, resume at reduced dose or permanently discontinue.