Romiplostim
Pharmaceutical drug
From Wikipedia, the free encyclopedia
Romiplostim, sold under the brand name Nplate among others, is a fusion protein analog of thrombopoietin, a hormone that regulates platelet production.
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| Trade names | Nplate, others |
| Other names | AMG531 |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a609008 |
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| Routes of administration | Subcutaneous |
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| Elimination half-life | 1 to 34 days |
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| Formula | C2634H4086N722O790S18 |
| Molar mass | 59085.01 g·mol−1 |
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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]
Medical uses
Romiplostim is indicated as a potential treatment for chronic idiopathic (immune) thrombocytopenic purpura (ITP).[2]
Clinical efficacy
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]
History
Romiplostim was developed by Amgen through a restricted usage program called NEXUS.[4] During development and clinical trials the drug was called AMG531.[5]
Romiplostim was designated an orphan drug by the US Food 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 as corticosteroids, intravenous immunoglobulin, Rho(D) immune globulin or splenectomy.[4][7]
Society and culture
Economics
The wholesale cost of romiplostim if administered weekly is currently estimated at US$55,250 per year.[8]
Research
Romiplostim may be used to treat acute 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]
