- Indications and Usage According to the National Medical Products Administration (NMPA) drug guide, Apatinib Mesylate Tablets are indicated for the following: Advanced Gastric Adenocarcinoma: For adult patients with advanced gastric or gastro-oesophageal junction adenocarcinoma who have received at least two prior systemic chemotherapy regimens. Advanced Hepatocellular Carcinoma: For adult patients with advanced hepatocellular carcinoma who have failed or are intolerant to prior systemic therapy.
- Dosage and Administration Recommended Dosage: Advanced Gastric Adenocarcinoma: The recommended dosage is 850 mg orally once daily. Advanced Hepatocellular Carcinoma: The recommended dosage is 750 mg orally once daily. Administration: The tablet should be swallowed whole with water half an hour after meals. Missed Dose: Missed doses should not be supplemented. Dose Modification: Dose reductions (e.g., to 750 mg, 500 mg, or 250 mg) and treatment interruptions are required based on the severity of adverse reactions.
- Mechanism of Action Apatinib is a small molecule tyrosine kinase inhibitor that selectively inhibits vascular endothelial growth factor receptor 2 (VEGFR-2). It inhibits tumor angiogenesis and tumor cell proliferation by blocking downstream signaling pathways.
- Safety and Warnings Hypertension: Blood pressure should be well controlled before initiating treatment. Monitor blood pressure regularly and manage as necessary. Proteinuria: Monitor urine protein regularly. Dose interruption or reduction may be required if proteinuria is ≥2+. Hemorrhage: Severe or fatal hemorrhagic events have occurred. Monitor and manage bleeding events promptly. Gastrointestinal Perforation: Monitor for abdominal pain; immediate discontinuation is required if perforation occurs. Hepatotoxicity: Monitor liver function tests regularly, especially in hepatocellular carcinoma patients. Severe hepatic impairment is a contraindication.
- Adverse Reactions and Clinical Research Common Adverse Reactions: The most common adverse reactions include hypertension, proteinuria, diarrhea, hand-foot skin reaction, fatigue, decreased appetite, and elevated liver enzymes. Clinical Research: In the pivotal Phase III clinical trials, apatinib demonstrated significant improvements in overall survival and progression-free survival compared to the placebo group in both advanced gastric cancer and hepatocellular carcinoma populations.
- Drug Interactions CYP3A4 Inhibitors: Strong CYP3A4 inhibitors may increase plasma concentrations of apatinib. CYP3A4 Inducers: Strong CYP3A4 inducers may decrease plasma concentrations of apatinib. QTc-Prolonging Drugs: Concomitant use may increase the risk of QTc interval prolongation.
- Pharmaceutical Information Composition: The active ingredient is Apatinib Mesylate. Excipients include microcrystalline cellulose, lactose monohydrate, sodium starch glycolate, and magnesium stearate. Appearance: White or off-white film-coated tablets. Storage: Store at controlled room temperature in the original packaging.
Aitan Apatinib Mesylate Tablets
Brand Name:艾坦 ®（ Aitan®）
Generic Name: Apatinib Mesylate
Strength: 0.25 g per tablet, 10 tablets per blister, 3 blisters per box
Manufacturer: Jiangsu Hengrui Medicine Co., Ltd.
Marketing Authorization Holder: Jiangsu Hengrui Medicine Co., Ltd.
Approval Date in China: October 17, 2014
Registration Number: 国药准字H20140103
Storage: Store tightly sealed, protected from light at temperature below 25°C. Refer to the full package insert for detailed storage specifications.
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