Alecensa Dosage/Direction for Use

General: A validated ALK assay is required for the selection of ALK-positive NSCLC patients. ALK-positive NSCLC status should be established prior to initiation of Alecensa therapy in first-line.
Alecensa hard capsules should be taken with food, swallowed whole and must not be opened or dissolved.
The recommended dose of Alecensa is 600 mg (four 150 mg capsules) given orally, twice daily (total daily dose of 1200 mg) (see Pharmacology: Pharmacokinetics under Actions).
Patients with underlying severe hepatic impairment should receive a dose of 450 mg given orally twice daily (total daily dose of 900 mg) (see Special Dosing Instructions in the following text and Pharmacology: Pharmacokinetics under Actions).
Duration of Treatment: It is recommended that patients are treated with Alecensa until disease progression or unmanageable toxicity.
Delayed or Missed Doses: If a planned dose of Alecensa is missed, patients can make up that dose unless the next dose is due within 6 hours. If vomiting occurs after taking a dose of Alecensa, patients should take the next dose at the scheduled time.
Dose Modifications: Management of adverse events may require temporary interruption, dose reduction, or discontinuation of treatment with Alecensa. The dose of Alecensa should be reduced in steps of 150 mg twice daily based on tolerability. Alecensa treatment should be permanently discontinued if patients are unable to tolerate the 300 mg twice daily dose.
Table 5 below gives general dose modification advice for Alecensa. (See Tables 5 and 6.)

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Special Dosage Instructions: Pediatric use: The safety and efficacy of Alecensa in children and adolescents (<18 years) have not been studied.
Geriatric use: No dose adjustment of Alecensa is required in patients ≥65 years of age.
Renal Impairment: No dose adjustment is required in patients with mild or moderate renal impairment. Alecensa has not been studied in patients with severe renal impairment, however since alectinib elimination via the kidney is negligible, no dose adjustment is required in patients with severe renal impairment (see Special Populations under Precautions and Pharmacology: Pharmacokinetics under Actions).
Hepatic Impairment: No dose adjustment is required in patients with mild hepatic impairment. Patients with underlying severe hepatic impairment should receive a dose of 450 mg given orally twice daily (total dose of 900 mg) (see Pharmacology: Pharmacokinetics under Actions).