Aibite Famitinib Malate Capsules

1. Indications and Usage
Hepatocellular Carcinoma: Indicated for the treatment of adult patients with hepatocellular carcinoma who have been previously treated with anti-angiogenic agents.
2. Dosage and Administration
Route of Administration: Oral administration.
Recommended Dosage: 450 mg once daily.
Administration Details: The capsule must be swallowed whole with water and should not be opened or chewed. It can be taken with or without food.
Management of Adverse Reactions: Dose interruptions, reductions, or permanent discontinuations may be required based on the severity of adverse reactions (e.g., hypertension, proteinuria, hand-foot syndrome).
Renal/Hepatic Impairment: Dose adjustments are not required for mild renal impairment. For moderate renal impairment, a reduction to 300 mg once daily is recommended. For moderate hepatic impairment, a reduction to 300 mg once daily is recommended. It is not recommended for patients with severe renal or hepatic impairment.
3. Mechanism of Action
Multi-Target TKI Inhibition: Famitinib is a small-molecule multi-target tyrosine kinase inhibitor.
Anti-Angiogenic and Anti-Tumor Effects: It primarily inhibits receptor tyrosine kinases including VEGFR-1, VEGFR-2, VEGFR-3, FGFR1-4, RET, and CSF-1R. This inhibits tumor angiogenesis and directly suppresses the proliferation of tumor cells.
4. Safety and Warnings
Hypertension: Monitor blood pressure regularly and manage with antihypertensive drugs as needed.
Proteinuria: Perform regular urinalysis; manage severe proteinuria by interrupting or permanently discontinuing treatment.
Hemorrhage and Thrombosis: Monitor for signs of hemorrhage or arterial/venous thromboembolism.
Gastrointestinal Perforation: Discontinue immediately if gastrointestinal perforation or fistula occurs.
Wound Healing Complications: Discontinue treatment prior to elective surgery and resume only after complete wound healing.
5. Adverse Reactions and Clinical Research
Most Common Adverse Reactions: Hypertension, proteinuria, fatigue, diarrhea, hand-foot syndrome, anorexia, stomatitis, and alopecia.
Clinical Research Highlights: Clinical trials have demonstrated that famitinib significantly improves progression-free survival compared to placebo in patients with advanced hepatocellular carcinoma.
6. Drug Interactions
CYP3A4 Inhibitors: Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin) may increase famitinib plasma concentrations; dose reduction may be necessary.
CYP3A4 Inducers: Strong CYP3A4 inducers (e.g., rifampin, carbamazepine) may decrease famitinib plasma concentrations and efficacy.
P-gp Substrates: Famitinib is a substrate of P-gp; concomitant use with P-gp inhibitors or inducers should be monitored.
7. Pharmaceutical Information
Chemical Composition: Active ingredient: Famitinib (as maleate).
Appearance: Hard gelatin capsules.
Packaging: Available in blister packs.
Storage: Store at controlled room temperature; protect from moisture.