ALECENSA HARD CAPSULE 150MG

ROCHE SINGAPORE PTE. LTD.

ROCHE SINGAPORE PTE. LTD.

Therapeutic

Prescription Only

CAPSULE

**2.2 Dosage and Administration** **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. Alecensa hard capsules should be taken with food. Capsules should be 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 section 3.2 Pharmacokinetic Properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)_. Patients with underlying severe hepatic impairment should receive a dose of 450 mg given orally twice daily (total daily dose of 900 mg) _(see sections 2.2.1 Special Dosing Instructions and 3.2.5 Pharmacokinetics in Special Populations – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)._ **Duration of Treatment** It is recommended that patients are treated with Alecensa until disease progression or unmanageable toxicity. **Delayed or Missed Doses** If a dose of Alecensa is missed or 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 1 below gives general dose modification advice for Alecensa.   **2.2.1 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 sections 2.5 Use in Special Populations and 3.2.5 Pharmacokinetics in Special Populations_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _)_. _Hepatic Impairment_ No dose adjustment is required in patients with underlying mild or moderate hepatic impairment. Patients with underlying severe hepatic impairment should receive a dose of 450 mg given orally twice daily (total daily dose of 900 mg) _(see section 3.2.5 Pharmacokinetics in Special Populations_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _)_.