Ensacove (Ensartinib Hydrochloride) – NSCLC | DengYueMed

Ensacove Application Scope

Ensacove is an oral, next‑generation ALK tyrosine kinase inhibitor to treat ALK‑positive non–small cell lung cancer (NSCLC).

Characteristics

• Ingredients: Ensartinib Hydrochloride

• Properties:

  • Oral ALK inhibitor with activity against ALK rearrangements, ROS1

  • Designed to penetrate the blood–brain barrier 

  • Overcome resistance to earlier ALK inhibitors

• Packaging Specification:

  • Capsules available in 25 mg and 100 mg strengths

  • Supplied in bottles or cartons, NDC-labeled for the U.S. market

• Storage:

  • Store at room temperature, protect from moisture

  • Keep in the original container

• Expiry Date: Provided on the package; follow label-dated expiration guidance

• Executive Standard:

  • In compliance with FDA (U.S.) and NMPA (China) regulations

  • Per capsule code ENSACOVE/ensartinib

• Approval Number:

  • FDA approved December 18, 2024

  • NMPA China 2020 (second‑line) and 2022 (first‑line) approvals

• Date of Revision: Last label update December 2024

• Manufacturer:

  • Developed by Xcovery Holdings

  • Distributed in China by Betta Pharmaceuticals

Guidelines for the Use of Ensacove

• Dosage and Administration:

  • Recommended dose:

    • 225 mg orally once daily, with or without food

  • Continue until disease progression or unacceptable toxicity

  • Capsules should be swallowed whole

  • If a dose is missed, take it within 12 h; don’t double-dose

• Adverse Reactions:

  • Common (≥20%):

    • rash, musculoskeletal pain, constipation, cough

    • pruritus, nausea, edema, vomiting, fatigue, fever

  • Lab abnormalities:

    • hyperglycemia, elevated liver enzymes

    • increased CPK, uric acid, electrolyte changes

• Contraindications: Known hypersensitivity to ensartinib or capsule excipients

• Precautions:

  • Monitor for dermatologic reactions (DRESS, photosensitivity)

  • Withhold or reduce the dose based on severity

  • Watch for bradycardia, hyperglycemia, and visual changes

  • Elevated CPK, hyperuricemia—adjust dose or suspend as needed

  • May cause fetal harm—advise contraception

  • Avoid use in patients with severe liver impairment

Ensacove Interactions

• Drug Interactions:

• Substrate of CYP3A4 and P-gp: avoid co-administration with strong

• Moderate inhibitors or inducers to prevent altered drug levels and toxicity

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.