ALECENSA Dosage/Direction for Use

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/Uses and Pharmacology: Pharmacodynamics: Clinical Studies under Actions). If ALK rearrangements are not detected in a plasma specimen, test tumor tissue if feasible.
Dosing and Administration: The recommended dose of ALECENSA is 600 mg orally twice daily (see Pharmacology: Pharmacokinetics under Actions). 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: Hepatic Impairment under Precautions and Pharmacology: Pharmacokinetics under Actions).
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 5. (See Table 5.)

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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 6. (See Table 6.)

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