Ensartinib Application Scope

Ensartinib is primarily used for the treatment of ALK-positive non-small cell lung cancer (NSCLC). It is an oral, potent, second-generation ALK tyrosine kinase inhibitor (TKI) designed to overcome resistance seen with first-generation TKIs like crizotinib.

Ensartinib Characteristics

Ingredients:
- Active Ingredient: Ensartinib hydrochloride
- Inactive Ingredients: Microcrystalline cellulose, stearic acid.
Properties:Ensartinib is a small molecule kinase inhibitor that selectively targets ALK and its variants, inhibiting tumor cell proliferation.

Packaging Specification:Supplied in bottles containing 30 capsules.
Storage:Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F).
Expiry Date: 30 months from the date of manufacture when stored under recommended conditions.
Executive Standard: Refer to the prescribing information approved by regulatory authorities.
Approval Number:NDA 218171 (U.S. FDA)
Date of Revision: December 2024
Manufacturer:Xcovery Holdings, Inc.

Guidelines for the Use of Ensartinib

Dosage and Administration:
- Recommended Dose: 225 mg orally once daily with or without food until disease progression or unacceptable toxicity.
- Administration: Swallow capsules whole; do not crush, chew, or open.
Adverse Reactions:
- Common Adverse Reactions (≥20%): Rash, pruritus, nausea, vomiting, diarrhea, fatigue, edema, and increased liver enzymes.
- Serious Adverse Reactions: Interstitial lung disease/pneumonitis, hepatotoxicity, and visual disturbances.
Contraindications: Hypersensitivity to Ensacove or any of its components.
Precautions:
- Hepatotoxicity: Monitor liver function tests periodically.
- Interstitial Lung Disease/Pneumonitis: Monitor for pulmonary symptoms; discontinue if confirmed.
- Visual Disturbances: Advise patients to report any visual symptoms.

Interactions

Drug Interactions:Coadministration with strong CYP3A inhibitors or inducers may affect Ensacove plasma concentrations; monitor accordingly.

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.