Ruilisheng Romiplostim N01 for Injection

1. Indications and Usage
Immune Thrombocytopenia (ITP):
Indicated for the treatment of thrombocytopenia in patients with immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
Populations: Adults and pediatric patients aged 1 year and older .
Acute Radiation Syndromes:
Indicated to increase survival in adult and pediatric patients (including term neonates) with acute radiation syndromes resulting from acute exposure to myelosuppressive doses of radiation (hematopoietic syndrome) .
2. Dosage and Administration
Route of Administration:
For Subcutaneous Injection ONLY.
Reconstitution:
Reconstitute each vial with Sterile Water for Injection. Do not shake the vial vigorously .
Recommended Dosage (ITP):
Starting Dose: 1 mcg/kg once weekly.
Dose Adjustment: Adjust the weekly dose by 1 mcg/kg increments to maintain the platelet count ≥ 50 × 10⁹/L.
Maximum Dose: 10 mcg/kg once weekly .
Administration Instructions:
Monitor platelet counts weekly until stable.
Dose Holding: Withhold the dose if the platelet count exceeds 400 × 10⁹/L. Resume at a dose at least 1 mcg/kg lower when platelet count decreases to < 200 × 10⁹/L .
3. Mechanism of Action
TPO Receptor Agonist:
Romiplostim is a peptibody that binds to the thrombopoietin receptor (c-Mpl) on the surface of hematopoietic stem cells .
Megakaryocyte Stimulation:
It mimics the action of endogenous TPO, stimulating the proliferation and differentiation of megakaryocytes in the bone marrow, leading to increased platelet production .
4. Safety and Warnings
Thrombotic/Thromboembolic Complications:
Overcorrection of the platelet count may increase the risk of thrombotic/thromboembolic complications.
Loss of Response:
Sudden loss of response may occur, often associated with the development of neutralizing antibodies.
Bone Marrow Reticulin Increase:
Treatment may be associated with increased bone marrow reticulin fibers. In rare cases, this can progress to myelofibrosis .
Malignancy Progression:
There is a potential risk of progression of myelodysplastic syndromes (MDS) to acute myeloid leukemia (AML) .
5. Adverse Reactions
Most Common:
Headache, arthralgia (joint pain), myalgia, insomnia, dizziness, nausea, vomiting, diarrhea, fatigue, and purpura .
Other Reported Reactions:
Cataracts, bone marrow fibrosis, and secondary malignancies.
6. Drug Interactions
No Specific Interactions:
No formal drug-drug interaction studies have been conducted.
Concomitant Medications:
Use caution when administering with other drugs that may increase the risk of bleeding or thrombosis.
7. Pharmaceutical Information
Chemical Composition:
Active Ingredient: Romiplostim (a recombinant Fc-peptide fusion protein).
Excipients: Histidine, Histidine Hydrochloride, Sucrose, Polysorbate 80 .
Storage:
Store at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze .