HCP section – ALECENSA Abbreviated Product Information
ALECENSA® (alectinib) capsules 150mg
Indications:
ALECENSA is indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC).
Dosage and Administration:
Administer with food, 600 mg orally twice daily. Administer until disease progression or unacceptable toxicity. For patients with severe hepatic impairment, 450mg orally twice daily with food. Refer to full prescribing information for the details of dose modifications.
Warnings and Precautions:
Hepatotoxicity: Monitor liver laboratory tests every 2 weeks during the first 3 months of treatment, and then once a month and as clinicically indicated. In case of severe ALT, AST, or bilirubin elevations, withhold, then reduce dose, or permanently discontinue ALECENSA. Interstitial Lung Disease (ILD)/Pneumonitis: Occurred in 0.7% of patients. Immediately withhold ALECENSA in patients diagnosed with ILD/pneumonitis and permanently discontinue if no other potential causes of ILD/pneumonitis have been identified. Renal Impairment: Permanently discontinue ALECENSA for Grade 4 renal toxicity. Withhold for Grade 3 renal toxicity until recover to ≤1.5 times ULN, then resume at reduced dose. Bradycardia: Monitor heart rate and blood pressure regularly. If symptomatic, withhold ALECENSA then reduce dose, or permanently discontinue. Severe Myalgia and Creatine Phosphokinase (CPK) Elevation: Assess CPK every 2 weeks during the first month of treatment and in patients reporting unexplained muscle pain, tenderness, or weakness. In case of severe CPK elevations, withhold, then resume or reduce dose. Embryo-Fetal Toxicity: ALECENSA can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.
Adverse Effects:
Fatigue, Constipation, Edema, Cough, Rash, Nausea, Headache, Diarrhea, Dyspnea, Back Pain, Increased weight, Vision disorder, Interstitial Lung Disease, Bradycardia, pneumonia, Renal Impairment, Severe Myalgia, Creatine Phosphokinase (CPK) Elevation, pulmonary embolism, hemorrhage, intestinal perforation, endocarditis, hyperbilirubinemia ,increased ALT levels, increased AST levels, bilirubin elevation, vomiting
Full prescribing information should be consulted prior to prescribing.
Date of preparation: Nov 2018