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| Clinical data | |
|---|---|
| Trade names | Nplate, others |
| Other names | AMG531 |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a609008 |
| License data | |
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| Routes of administration | Subcutaneous |
| ATC code | |
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| Pharmacokinetic data | |
| Eliminationhalf-life | 1 to 34 days |
| Identifiers | |
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| CAS Number | |
| IUPHAR/BPS | |
| DrugBank |
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| UNII | |
| KEGG | |
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| Chemical and physical data | |
| Formula | C2634H4086N722O790S18 |
| Molar mass | 59085.01 g·mol−1 |
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Romiplostim, sold under the brand nameNplate among others, is afusion protein analog ofthrombopoietin, ahormone that regulatesplatelet production.
The most common side effects in adults include headache, infections of the nose and throat, and allergic (hypersensitivity) reactions such as rash, itching and rapid swelling under the skin.[1] The most common side effects in children include infections of the nose and throat, runny nose, cough, fever, mouth and throat pain, abdominal (belly) pain, diarrhea, rash, and bruising.[1]
Romiplostim isindicated as a potential treatment forchronic idiopathic (immune) thrombocytopenic purpura (ITP).[2]
In well designed, 24-week, Phase III trials, romiplostim was significantly more effective than placebo in achieving the primary endpoint of a protocol-defined durable platelet response in nonsplenectomized or splenectomized adults with chronic immune thrombocytopenic purpura.[3]
Romiplostim was developed byAmgen through a restricted usage program called NEXUS.[4] During development andclinical trials the drug was called AMG531.[5]
Romiplostim was designated anorphan drug by the USFood and Drug Administration (FDA) in 2003[6]
In August 2008, the FDA approved romiplostim as a long-term treatment for chronic immune thrombocytopenia in adults who have not responded to other treatments, such ascorticosteroids,intravenous immunoglobulin,Rho(D) immune globulin orsplenectomy.[4][7]
The wholesale cost of romiplostim if administered weekly is currently estimated at US$55,250 per year.[8]
Romiplostim may be used to treatacute radiation syndrome.[9] "To reduce radiation-induced bleeding, Nplate stimulates the body’s production of platelets. The drug can be used to treat adults and children."[9]
