Description
Romiset (Romiplostim 250 MCG Injections)
Romiplostim injection is a thrombopoietin receptor agonist used for the treatment of thrombocytopenia in:Â
- Adult patients with immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
- Pediatric patients 1 year of age and older with ITP for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.Â
Romiplostim injection is used to increase survival in adults and pediatric patients (including term neonates) acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [HSARS]).Â
Limitations of Use:
-
- Romiplostim is not for treating individuals with thrombocytopenia due to myelodysplastic syndrome (MDS) or any cause of thrombocytopenia other than ITP.
- This medicine should be used only in those with ITP whose degree of thrombocytopenia and clinical condition increases the probability of bleeding.
- This therapeutic drug should not be used in an attempt to normalize platelet counts.
Dosage and Side Effects of Romiplostim Injection:
Patients with Immune Thrombocytopenia (ITP):Â The recommended initial dose is 1 mcg/kg once weekly as a subcutaneous (SC) injection. Dosage can be adjusted based on platelet response.
Patients acutely exposed to myelosuppressive doses of radiation: The recommended dose is 10 mcg/kg administered once as a subcutaneous (SC) injection. Administer the dose as promptly as possible after suspected or confirmed exposure to myelosuppressive doses of radiation.
The most common side effects of Romiplostim 250 mcg injection in adult patients are arthralgia, dizziness, pain in extremities, insomnia, abdominal pain, myalgia, shoulder pain, dyspepsia, and paresthesia. Side effects in pediatric patients are contusion, upper respiratory tract infection, and oropharyngeal pain.
Warning and Precautions of Romiplostim Injection:
- Romiplostim250 mcg injection can increase the risk of blood clot formation (thrombosis), including blood clots in veins (venous thromboembolism) and arteries (arterial thrombosis). It should be used with caution in individuals with a history of blood clotting disorders or those at increased risk of thrombosis.
- Regular monitoring of platelet counts and other blood parameters is essential during treatment with Romiplostim to ensure appropriate dosing and to detect any potential side effects promptly.
- While this medicinal product helps increase platelet counts, it may not reduce the probability of bleeding in all individuals. Patients need to be monitored for signs and symptoms of bleeding and managed accordingly.
- This therapeutic drug may lead to changes in bone marrow, including an increase in reticulin fibers. Bone marrow evaluations should be conducted periodically throughout treatment.
- Some individuals may experience hypersensitivity reactions, including rash, itching, and difficulty breathing, after taking Romiplostim. If any allergic reactions occur, immediate medical attention should be sought.
- This medication should be used with caution in individuals with hepatic impairment, as it can affect liver function tests. Regular monitoring of liver function is recommended.
- The safety and efficacy of Romiplostim in pediatric patients have not been established. Its use in this population should be carefully considered based on individual patient factors.
- The effects of this medicine on pregnancy and breastfeeding are not well studied. It should only be used during pregnancy if the potential benefits justify the potential risks to the fetus, and breastfeeding should be avoided while receiving treatment.
