Mailisheng Albipagrastim alfa for Injection

1. Indications and Usage
Chemotherapy-Induced Thrombocytopenia (CIT): Treatment of chemotherapy-induced thrombocytopenia in adult patients with non-myeloid malignancies who have received myelosuppressive chemotherapy.
2. Dosage and Administration
Route of Administration: For Subcutaneous (SC) Injection ONLY.
Recommended Dosage: 300 μg administered at least 24 hours after chemotherapy administration. The dose can be repeated once every 7 days as needed.
Critical Administration Instructions:
Maximum Cycles: Treatment should not exceed 6 cycles.
Dosing Time: If thrombocytopenia persists beyond 7 days, the next dose should be administered on day 8 or later.
Discontinuation: Treatment should generally be discontinued when the platelet count reaches or exceeds 50 × 10⁹/L.
3. Mechanism of Action
TPO Receptor Agonism: Albipagrastim alfa is a recombinant human TPO receptor agonist.
Megakaryocyte Stimulation: It binds to and activates the TPO receptor (c-Mpl) on hematopoietic stem cells and megakaryocytes.
Platelet Production: This stimulation promotes the proliferation and differentiation of megakaryocytes, leading to increased platelet production.
4. Safety and Warnings
Thromboembolic Events: Potential risk of thrombosis or thromboembolism.
Bone Marrow Fibrosis: Long-term use of TPO receptor agonists may lead to reticulin fibrosis in the bone marrow.
Hypersensitivity: Serious allergic reactions may occur.
Thrombocytopenia: Paradoxical thrombocytopenia has been reported in rare cases.
5. Adverse Reactions and Clinical Research
Most Common Adverse Reactions: Headache, nausea, vomiting, diarrhea, and injection site reactions.
Clinical Research Highlights: Phase 3 clinical trials demonstrated that Albipagrastim alfa significantly reduced the incidence of severe thrombocytopenia and the need for platelet transfusions compared to placebo.
6. Drug Interactions
Chemotherapy Agents: No significant pharmacokinetic interactions are expected, but administration must be timed at least 24 hours after chemotherapy.
Other TPO Agonists: Concomitant use with other TPO receptor agonists is not recommended.
7. Pharmaceutical Information
Chemical Composition: Active Ingredient: Albipagrastim alfa. Excipients: Sucrose, Sodium phosphate, Polysorbate 20.
Appearance: White to off-white lyophilized cake or powder.
Packaging: Single-use vial.
Storage: Store in the original carton at 2°C to 8°C. Do not freeze.