Tpiao Recombinant Human Thrombopoietin Injection

1. Indications and Usage
Chemotherapy-Induced Thrombocytopenia (CIT): Treatment of adult patients with solid tumor chemotherapy-induced thrombocytopenia who have a platelet count <50 × 10⁹/L and require intervention.
Immune Thrombocytopenia (ITP): Adjunctive treatment for adult patients with primary ITP who have failed to achieve a response with corticosteroid therapy (including initial non-response, relapse, or ineffective response).
2. Dosage and Administration
Route of Administration: For Subcutaneous (SC) Injection ONLY.
Recommended Dosage: 300 U/kg administered once daily.
Treatment Duration: Generally administered for up to 14 consecutive days.
Critical Administration Instructions:
CIT: Initiate administration 6 to 24 hours after chemotherapy completion. Discontinue immediately when the platelet count recovers to ≥100 × 10⁹/L or has increased by ≥50 × 10⁹/L from baseline.
ITP: Discontinue immediately if the platelet count reaches ≥100 × 10⁹/L within the 14-day course.
Preparation: Reconstitute with the provided Sterile Water for Injection. Gently swirl to dissolve; do not shake vigorously.
3. Mechanism of Action
TPO Receptor Binding: rhTPO binds with high affinity to the thrombopoietin receptor (c-Mpl) on hematopoietic stem and progenitor cells, as well as megakaryocytes.
Megakaryocyte Proliferation: It stimulates the proliferation and differentiation of megakaryocyte precursor cells.
Platelet Generation: This promotes the maturation of polyploid megakaryocytes, leading to an increased production of functional platelets.
4. Safety and Warnings
Thromboembolic Events: Excessive platelet elevation may increase the risk of thrombosis or thromboembolism.
Contraindications: Contraindicated in patients with severe cardiovascular or cerebrovascular disease, other hypercoagulable states, or recent thrombotic events.
Hypersensitivity: Hypersensitivity reactions may occur, including cross-reactivity for patients allergic to Chinese Hamster Ovary (CHO) cell proteins.
Bone Marrow Fibrosis: Long-term or excessive use of TPO receptor agonists carries a risk of reticulin fibrosis in the bone marrow.
5. Adverse Reactions and Clinical Research
Most Common Adverse Reactions: Fever, chills, myalgia, headache, dizziness, fatigue, and injection site pain.
Clinical Research Highlights: Clinical trials demonstrated that rhTPO significantly accelerated platelet recovery in CIT and increased platelet counts in steroid-refractory ITP, reducing the need for platelet transfusions.
6. Drug Interactions
Chemotherapy/Radiotherapy: Concomitant administration may increase the sensitivity of rapidly proliferating megakaryocyte progenitor cells to cytotoxic damage. Administration should be delayed until 6–24 hours after chemotherapy or 12 hours after radiotherapy.
Other Hematopoietic Growth Factors: May be co-administered with recombinant human granulocyte colony-stimulating factor (rhG-CSF) or erythropoietin (rhEPO) if leukopenia or anemia occurs concurrently.
7. Pharmaceutical Information
Chemical Composition: Active Ingredient: Recombinant Human Thrombopoietin (produced in CHO cells). Excipients: Human albumin, sodium chloride.
Appearance: White or off-white lyophilized cake or powder. The provided solvent is Sterile Water for Injection.
Packaging: Single-use vial (7500 U or 15000 U).
Storage: Store in the original carton at 2°C to 8°C. Do not freeze.