Product Information
Romy 250 mcg Injection is formulated with Romiplostim, a fusion protein that mimics the action of thrombopoietin—a natural hormone responsible for regulating platelet production. By binding to and activating thrombopoietin receptors on megakaryocyte progenitor cells in the bone marrow, Romy promotes the proliferation and differentiation of these cells into platelets, thereby increasing platelet counts in patients with chronic ITP.
This therapeutic approach helps reduce the risk of bleeding associated with low platelet counts and offers an alternative for patients who have not responded adequately to conventional treatments.
Indications
Romy 250 mcg Injection is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to:
- Corticosteroids
- Immunoglobulins
- Splenectomy
Composition
Each vial of Romy 250 mcg Injection contains:
- Active Ingredient: 250 micrograms of Romiplostim.
- Inactive Ingredients: Mannitol, sucrose, L-histidine, polysorbate 20, and hydrochloric acid (to adjust pH).
Dosage and Administration
- Initial Dose: 1 microgram per kilogram of actual body weight, administered once weekly as a subcutaneous injection.
- Dose Adjustments: Adjust the weekly dose by increments of 1 microgram/kg to achieve and maintain a platelet count of ≥50 x 10⁹/L as necessary to reduce the risk of bleeding.
- Maximum Dose: Do not exceed 10 micrograms/kg per week.
- Discontinuation: If platelet counts do not increase to a sufficient level after 4 weeks at the maximum dose, discontinue Romy.
Note: Platelet counts should be monitored weekly until a stable count (≥50 x 10⁹/L) is achieved, and monthly thereafter.
Precautions
- Bone Marrow Reticulin Formation and Risk for Bone Marrow Fibrosis: Monitor patients for signs of bone marrow fibrosis.
- Thrombotic/Thromboembolic Complications: Use caution in patients with known risk factors for thromboembolism.
- Progression of Myelodysplastic Syndromes (MDS): Romiplostim is not indicated for use in patients with MDS.
- Rebound Thrombocytopenia: Upon discontinuation, monitor platelet counts closely to detect potential decreases.
- Hypersensitivity Reactions: Be vigilant for signs of allergic reactions; discontinue use if severe reactions occur.
- Pregnancy and Lactation: Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Caution is advised when administered to nursing mothers.
Storage
- Store refrigerated at 2°C to 8°C (36°F to 46°F).
- Protect from light; keep vials in the original carton until use.
- Do not freeze.
Note
- Administration: Reconstitute the lyophilized powder with the provided solvent and administer as a subcutaneous injection.
- Monitoring: Regular monitoring of platelet counts is essential to adjust dosing and minimize risks.
- Patient Education: Inform patients about the importance of adherence to dosing schedules and monitoring appointments.
