- Indications and Usage Chronic Liver Disease: Indicated to increase platelet counts in adult patients with chronic liver disease who are facing an elective procedure, to reduce the need for platelet transfusions. Chronic Immune Thrombocytopenia (ITP): Indicated for the treatment of adult patients with chronic ITP who have had an insufficient response to prior treatment.
- Dosage and Administration Chronic Liver Disease: Initiate 10-13 days before the scheduled elective procedure. The weekly dose is determined by baseline platelet count and weight (20 mg to 30 mg total weekly). Chronic ITP: Start at 20 mg taken orally once daily with food. Adjustments can be made based on platelet response, but doses should not be stacked or missed to counteract. Administration: Tablets must be taken with food to facilitate absorption. The total weekly dosage should not exceed 40 mg for liver disease or 50 mg for ITP.
- Mechanism of Action TPO Receptor Agonism: Avatrombopag is an oral prodrug that is rapidly converted to its active diacid metabolite in the liver. Megakaryocyte Stimulation: It binds selectively and potently to the thrombopoietin (TPO) receptor (c-Mpl) on human megakaryocytes, stimulating megakaryocyte proliferation and differentiation, and subsequently increasing platelet production without competing with endogenous TPO.
- Safety and Warnings Thrombotic/Thromboembolic Risk: Serious and sometimes fatal thrombotic events (arterial or venous) may occur. Close monitoring of platelet counts is mandatory to avoid excessive elevation, and the drug should be discontinued once the threshold for the procedure is reached. Hypertension: New-onset or exacerbated hypertension has been observed. Blood pressure should be monitored and managed. Bone Marrow Reticulin Fibrosis: Assessment of bone marrow morphology may be necessary after multiple courses in ITP patients.
- Adverse Reactions and Clinical Research Most Common Adverse Reactions: Abdominal pain, headache, nausea, fatigue, nausea, and pyrexia (in chronic liver disease); nasopharyngitis, hypertension, and musculoskeletal pain (in ITP). Clinical Research: Phase 3 trials (ADAPT-1 and ADAPT-2) confirmed efficacy in reducing transfusion requirements for chronic liver disease. In ITP, long-term data demonstrate high rates of platelet response and sustained remission without significant hepatotoxicity.
- Drug Interactions Proton Pump Inhibitors (PPIs): PPIs may decrease the absorption of avatrombopag. If necessary, they should be administered separately (e.g., at least 4 hours before or after avatrombopag). CYP Enzyme Interactions: Avatrombopag is metabolized to its active form via esterases and is not significantly metabolized by cytochrome P450 enzymes, making it a low-risk candidate for CYP-mediated drug interactions. However, high doses of H2 receptor antagonists should still be staggered.
- Pharmaceutical Information Chemical Composition: Active ingredient: Avatrombopag (as Maleate). Appearance: Red to orange, capsule-shaped, film-coated tablets. Storage: Store at 20°C to 25°C (68°F to 77°F) in the original container to protect from moisture.
Sukexin Avatrombopag Maleate Tablets
Brand Name: 苏可欣 ®（Sukexin®）
Generic Name: Avatrombopag Maleate
Strength: 20 mg per tablet, 10 tablets per blister pack, 1 blister per box
Manufacturer: Kawashima Plant, Eisai Co., Ltd.
Marketing Authorization Holder: AkaRx, Inc. (Domestic distributor: Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd.)
Approval Date in China: April 30, 2020
Registration Number: 国药准字HJ20200005
Storage: Store in the original package at 20°C–25°C; short-term storage between 15°C–30°C is permitted. Protect from moisture. Refer to the full package insert for detailed storage specifications.
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