- Details
- Description
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Packaging Size1 Ampoule/Bottle
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Strength250ug/vial (250mcg/vial)
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CompositonRomiplostim
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TreatmentChronic Immune Thrombocytopenia (ITP)
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FormInjecton
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BrandRomiplostim N01
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Quantity Unit250ug/vial/Box
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ManufacturerQILU Pharmaceutical Co.,Ltd,China
About Romiplostim N01
Romiplostim is a weekly injectable medication used to treat low blood platelets (thrombocytopenia) in adults and children with immune thrombocytopenia (ITP) who haven't responded to other treatments. It is also approved to treat Hematopoietic Syndrome of Acute Radiation Syndrome following severe radiation exposure.
N01 represents the first biosimilar version approved in China.
Chronic Immune Thrombocytopenia (ITP)
Indicated for immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy
Initial
- 1 mcg/kg SC qWeek
- Use lowest dose of Nplate to achieve and maintain a platelet count ≥50 x 109/L as necessary to reduce the risk for bleeding
Dose adjustment
- Adjust weekly dose by increments of 1 mcg/kg until platelet count ≥50 x 109/L as necessary to reduce the risk for bleeding; not to exceed maximum weekly dose of 10 mcg/kg
- Median dose of 2 mcg/kg in clinical studies
Determine dose adjustment by platelet count
- Platelets <50 x 109/L: Increase by 1 mcg/kg
- Platelet >200 to ≤400 x 109/L for 2 consecutive weeks: Reduce by 1 mcg/kg
- Platelet >400 x 109/L: Do not give dose; continue weekly platelet assessment, if platelets fall to <200 x 109/L, resume at dose reduced by 1 mcg/kg
- Discontinue if platelet count does not increase to sufficient level in order to avoid clinically important bleeding after 4 weeks at 10 mcg/kg
Hematopoietic Syndrome of Acute Radiation Syndrome
Indicated to increase survival in adults and in pediatric patients (including term neonates) acutely exposed to myelosuppressive doses of radiation
10 mcg/kg SC x 1 dose
Administer as soon as possible after suspected or confirmed exposure to radiation levels >2 gray (Gy)
Dosage Modifications
Renal or hepatic impairment: Not studied
Dosing Considerations
Limitations of use
- Not indicated for thrombocytopenia due to myelodysplastic syndrome (MDS) or any cause of thrombocytopenia other than chronic ITP
- Only use in patients with ITP whose degree of thrombocytopenia and clinical condition increases the risk for bleeding
- Do not use as an attempt to normalize platelet counts
Monitoring parameters
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CBC, including platelet counts
- During treatment: Obtain weekly during dose adjustment phase, and then monthly once stable dose established
- Discontinuation: Obtain weekly for at least 2 weeks following discontinuation
Aplastic Anemia (Orphan)
Orphan designation for treatment of aplastic anemia
