Alectinib Alecensa

[Drug Name] Alectinib

[Brand Name] Alecensa

[Indications] Lung Adenocarcinoma, Lung Squamous Cell Carcinoma, Large Cell Lung Carcinoma

[Dosage Form / Route of Administration] Oral

[Drug Class] Targeted Therapy Agent

[Indications]

Alectinib is a kinase inhibitor indicated for the treatment of patients with ALK-positive metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on or who are intolerant to crizotinib. This indication is approved under accelerated approval based on tumor response rate and duration of response data from clinical trials. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

[Adverse Reactions] Edema, Constipation, Fatigue, Myalgia (Muscle Pain)

[Dosage and Administration] 600 mg orally, twice daily, taken with food.

[Precautions]

Hepatotoxicity: Monitor liver function tests (ALT, AST, and bilirubin) every 2 weeks during the first 2 months of treatment, and periodically thereafter. If severe elevations in ALT or AST, or elevations in bilirubin occur, withhold the drug, then resume at a reduced dose, or permanently discontinue.

Interstitial Lung Disease (ILD)/Pneumonitis: ILD/pneumonitis occurred in 0.4% of patients in clinical trials. If diagnosed, withhold the drug immediately. If no other potential causes are identified, permanently discontinue Alectinib.

Bradycardia: Monitor heart rate and blood pressure regularly. If symptomatic, withhold the drug, then resume at a reduced dose, or permanently discontinue.

Severe Myalgia/Elevated Creatine Phosphokinase (CPK): Severe myalgia occurred in 1.2% of patients, and CPK elevations occurred in 4.6% of patients in clinical trials. Monitor CPK levels every 2 weeks during the first month of treatment, and in patients who report unexplained muscle pain, tenderness, or weakness. If severe CPK elevations occur, withhold the drug, then resume at the same dose or a reduced dose. Embryo-Fetal Toxicity: Alectinib may cause fetal harm. Advise female patients of reproductive potential regarding the potential risk to the fetus and the need to use effective contraception.

Product Specifications

Product Name: Roche Original Alectinib (Alecensa)

Common Name: Alectinib

Active Ingredient: Alectinib

Dosage Form: Capsule

Specification: 150 mg × 224 capsules

Manufacturer: Roche Pharmaceuticals

Indications: Pulmonary Adenocarcinoma, Pulmonary Squamous Cell Carcinoma, Large Cell Lung Carcinoma

Dosage and Administration:600 mg orally, twice daily, taken with food.