Alecensa Application Scope

Alecensa is an oral, highly selective ALK tyrosine kinase inhibitor used to treat ALK‑positive non‑small cell lung cancer.

alecensa

Characteristics

Properties: White to yellow‑white capsules; non‑flammable solid
Packaging Specification: Blister‑packaged 150 mg capsules; container types include blister, stainless steel, and glass
Storage: Store in a dry, well‑ventilated area, protect from heat, moisture, and light; keep container tightly closed
Expiry Date: As labeled on blister pack; capsules are stable if stored per instructions
Executive Standard:
- EU: EMA Summary of Product Characteristics
- US: FDA label with full prescribing information
Approval Number:
- US FDA: NDA 208434, first approved December 11, 2015
- EMA: authorized under the EU centralized procedure
- Australia (TGA): registered December 23, 2024
Date of Revision:
- US label: most recent revision date March 24, 2023; safety updates revised January 29, 2024
- EMA: product information updated as of mid‑2024

Manufacturer: Genentech, Inc. (a member of the Roche group), South San Francisco, CA, USA

Dosage and Administration:
- Recommended dose: 600 mg orally twice daily with food; continue until disease progression or unacceptable toxicity
- Dose reductions are available (450 mg or 300 mg BID) for managing adverse events such as hepatotoxicity, myalgia, or bradycardia
Adverse Reactions:
- Very common (≥ 20%): constipation, muscle pain, edema, anaemia, elevated liver enzymes, and bilirubin
- Serious risks: hepatotoxicity (monitor liver every 2 weeks ×3 months, then monthly)
- interstitial lung disease/pneumonitis, bradycardia, severe myalgia, kidney problems, hemolytic anemia
Contraindications:
- None officially listed, but avoid in pregnancy.
- Use highly effective contraception during and up to 5 weeks after treatment in women, and up to 3 months in men
Precautions:
- Monitor liver tests, cardiac rhythm, pulmonary symptoms, muscle CPK, renal function;
- Counsel on photosensitivity and avoid strong sunlight

Drug Interactions:
- No strong CYP450 inhibitors/inducers specified
- Monitor when co‑administered with such agents

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.