Ensacove Ensartinib Hydrochloride Capsules

1. Indications and Usage
Non-Small Cell Lung Cancer (NSCLC):
Indicated for the treatment of patients with locally advanced or metastatic ALK-positive non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.
2. Dosage and Administration
Recommended Dosage:
Dose: 225 mg orally once daily.
Administration: Administer at the same time each day. Can be taken with or without food. Swallow capsules whole with water.
Missed Dose:
If a dose is missed by more than 12 hours before the next scheduled dose, take the missed dose. Do not take an extra dose if vomiting occurs.
Dose Reduction:
First reduction: 200 mg once daily; Second reduction: 150 mg once daily.
3. Mechanism of Action
ALK Inhibition:
Ensartinib is a tyrosine kinase inhibitor (TKI) that targets the anaplastic lymphoma kinase (ALK) receptor.
Physiological Effect:
It inhibits the autophosphorylation of ALK and the phosphorylation of downstream signaling molecules (such as AKT, ERK, and S6), thereby suppressing the proliferation and inducing apoptosis of tumor cells.
4. Safety and Warnings
Hepatotoxicity:
Drug-induced hepatotoxicity (elevated ALT/AST) may occur. Monitor liver function tests regularly.
Cutaneous Toxicity:
Rash and pruritus are common adverse reactions. Monitor skin conditions.
Embryo-Fetal Toxicity:
May cause fetal harm. Females of reproductive potential should use effective contraception.
5. Adverse Reactions
Most Common:
Rash, pruritus, nausea, constipation, vomiting, diarrhea, edema, and fatigue.
Laboratory Abnormalities:
Increased ALT, increased AST, increased creatinine.
6. Drug Interactions
CYP3A4 Inhibitors:
Ensartinib is metabolized mainly by CYP3A4. Avoid concomitant use with strong CYP3A4 inhibitors (e.g., itraconazole, clarithromycin) as they may increase Ensartinib plasma concentrations.
CYP3A4 Inducers:
Strong CYP3A4 inducers (e.g., rifampin) may decrease the efficacy of Ensartinib.
7. Pharmaceutical Information
Chemical Composition:
Active Ingredient: Ensartinib Hydrochloride.
Storage:
Store in the original package at or below 25°C. Protect from moisture.