ALECENSA HARD CAPSULE 150MG [SIN15220P]

Product Info

ALECENSA HARD CAPSULE 150MG

[SIN15220P]

Indication

2.1 Therapeutic Indication
Adjuvant Treatment of Resected Non-Small Cell Lung Cancer
Alecensa as monotherapy is indicated as adjuvant treatment following complete tumor resection for adult patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) at high risk of recurrence (see section 3.1.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Treatment of Locally Advanced or Metastatic NSCLC
Alecensa is indicated for the first-line treatment of patients with ALK-positive locally advanced or metastatic NSCLC.

Alecensa is indicated for the treatment of patients with ALK-positive, locally advanced or metastatic NSCLC who have progressed on or are intolerant to crizotinib.

Dosing

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
Adjuvant Treatment of Resected NSCLC
It is recommended that patients are treated with Alecensa until disease recurrence or unmanageable toxicity or for 2 years.

Treatment of Locally Advanced or Metastatic NSCLC
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).

Contraindications

2.3 Contraindications
Alecensa is contraindicated in patients with a known hypersensitivity to alectinib or any of the excipients.