Ensacove Ensartinib Hydrochloride Capsules Application Scope

Treatment of adult patients with ALK‑positive, locally advanced or metastatic non‑small cell lung cancer (NSCLC), including both treatment-naïve (first-line) and those previously treated or intolerant to crizotinib.

Ensacove Ensartinib Hydrochloride Capsules Characteristics

Ingredients: Active: ensartinib hydrochloride (aminopyridazine-based ALK TKI)
Excipients: microcrystalline cellulose, stearic acid; hypromellose, titanium dioxide, and colorants including FD&C Yellow No.5
Properties: Oral small-molecule tyrosine kinase inhibitor targeting ALK (also ROS1, MET, EphA2)
Packaging Specification: Hard capsules, available in 25 mg and 100 mg strengths
Storage: Store at controlled room temperature (≤ 25 °C), avoid moisture
Expiry Date: As per printed packaging; shelf life determined per batch
Executive Standard: Meets requirements for prescription oncology drugs in China and US labeling standards
Approval Number: NMPA: H20200009 (25 mg) & H20200010 (100 mg); first approved November 19, 2020 for ALK‑positive NSCLC after crizotinib failure
FDA: NDA 218171 approved December 18, 2024 for first-line use in ALK-positive advanced/metastatic NSCLC
Date of Revision: Most label revisions follow FDA approval in December 2024; NMPA first-line addition in March 2022
Manufacturer: Betta Pharmaceuticals Co., Ltd. / Xcovery, Inc. (US)

Guidelines for the Use of Ensartinib Hydrochloride Capsules

Dosage and Administration:
- Recommended Dose: 80 mg administered subcutaneously once every 4 weeks.
- Administration: Administer via subcutaneous injection using the single-dose autoinjector.
- Missed Dose: If a dose is missed, administer as soon as possible. Resume monthly dosing from the date of the most recently administered dose.
Adverse Reactions:
- Common Adverse Reactions (≥5% and >3% higher than placebo):
  - Injection site reactions (19%)
  - Decreased platelet count (12%)
  - Arthralgia (9%)
- Serious Adverse Reactions:
  - Hypersensitivity reactions, including bronchospasm, diffuse erythema, facial swelling, urticaria, chills, and myalgias.
Contraindications:Patients with a history of serious hypersensitivity to olezarsen or any of the excipients in TRYNGOLZA.
Precautions:
- Hypersensitivity Reactions: Monitor patients for signs and symptoms. Discontinue use if reactions occur.
- Platelet Count Monitoring: Monitor platelet counts during treatment.
- Pregnancy and Lactation: Advise patients to inform their healthcare provider if they are pregnant, plan to become pregnant, are breastfeeding, or plan to breastfeed.

Drug Interactions

Metabolized primarily by CYP3A4: avoid or adjust when co-administered with strong CYP3A4 inhibitors or inducers

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.