Fukewei Anlotinib Hydrochloride Capsules

1. Indications and Usage
Non-Small Cell Lung Cancer (NSCLC): Treatment of locally advanced or metastatic NSCLC in patients who have progressed following at least two prior systemic chemotherapy regimens.
Small Cell Lung Cancer (SCLC): Treatment of extensive-stage SCLC in patients who have progressed following at least two prior chemotherapy regimens.
Hard Tissue Sarcoma: Treatment of adult patients with locally advanced or metastatic hard tissue sarcoma who have progressed after prior chemotherapy.
2. Dosage and Administration
Route of Administration: Oral administration ONLY.
Recommended Dosage: 12 mg once daily.
Administration Schedule: Taken for 2 consecutive weeks followed by 1 week of rest, constituting a 21-day cycle. Continue until disease progression or unacceptable toxicity.
Critical Administration Instructions:
Timing: Administer on an empty stomach (at least 1 hour before or 2 hours after meals).
Missed Dose: If a dose is missed and it has been less than 12 hours until the next scheduled dose, do not take the missed dose.
Dose Modifications: For adverse reactions, reduce the dose to 10 mg/day (first reduction) or 8 mg/day (second reduction). If 8 mg/day is not tolerated, permanently discontinue.
3. Mechanism of Action
Multi-Target Inhibition: Anlotinib is a potent inhibitor of vascular endothelial growth factor receptors (VEGFR1-3), platelet-derived growth factor receptor (PDGFRα), fibroblast growth factor receptor (FGFR1), and c-Kit.
Anti-Angiogenesis: Inhibition of VEGFR blocks tumor angiogenesis and reduces microvessel density.
Antitumor Effect: Inhibition of PDGFR, FGFR, and c-Kit inhibits tumor cell proliferation and promotes tumor cell apoptosis.
4. Safety and Warnings
Hemorrhage: Anlotinib increases the risk of hemorrhage (e.g., hemoptysis, gastrointestinal bleeding). Patients with central squamous cell carcinoma or high risk of hemoptysis are contraindicated.
Thromboembolism: Increases the risk of arterial and venous thromboembolic events.
Hypertension: May cause dose-dependent hypertension; requires regular blood pressure monitoring and management.
Hepatotoxicity: Elevations in ALT, AST, and bilirubin may occur. Liver function tests should be monitored regularly.
Fetal Toxicity: May cause fetal harm; effective contraception is required during and for 6 months after treatment.
5. Adverse Reactions and Clinical Research
Most Common Adverse Reactions: Hypertension, fatigue, hand-foot skin reaction, gastrointestinal disorders (nausea, anorexia), and liver function abnormalities.
Common Laboratory Abnormalities: Increased proteinuria, hyperlipidemia, hypothyroidism, neutropenia, and thrombocytopenia.
Clinical Research Highlights: The ALTER0303 trial demonstrated significant improvement in progression-free survival and overall survival in the NSCLC population.
6. Drug Interactions
CYP1A2 and CYP3A4/5 Inhibitors: Strong inhibitors (e.g., ciprofloxacin, ketoconazole) may increase anlotinib plasma concentrations. Avoidance or dose reduction is recommended.
CYP1A2 and CYP3A4/5 Inducers: Strong inducers (e.g., rifampin, phenytoin) may decrease anlotinib plasma concentrations. Avoidance is recommended.
Drugs Affecting Hemostasis: Concomitant use with anticoagulants or antiplatelet agents may increase the risk of bleeding.
7. Pharmaceutical Information
Chemical Composition: Active Ingredient: Anlotinib Hydrochloride.
Appearance: Hard gelatin capsules containing white or off-white powder or granules.
Packaging: Available in 8 mg, 10 mg, and 12 mg strengths.
Storage: Store at controlled room temperature (20°C to 25°C); protect from moisture and light.