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Romiplostim

Pharmaceutical drug

Pharmaceutical drug

| Drugs.com =

| elimination_half-life = 1 to 34 days

Romiplostim, sold under the brand name Nplate among others, is a fusion protein analog of thrombopoietin, a hormone that regulates platelet 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. 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.

Medical uses

Romiplostim is indicated as a potential treatment for chronic idiopathic (immune) thrombocytopenic purpura (ITP).

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.

History

Romiplostim was developed by Amgen through a restricted usage program called NEXUS.

Romiplostim was designated an orphan drug by the US Food and Drug Administration (FDA) in 2003

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.

Society and culture

Economics

The wholesale cost of romiplostim if administered weekly is currently estimated at US$55,250 per year.

Research

Romiplostim may be used to treat acute radiation syndrome. "To reduce radiation-induced bleeding, Nplate stimulates the body’s production of platelets. The drug can be used to treat adults and children."

References

References

  1. (27 May 2005). "Nplate EPAR".
  2. (February 2008). "Efficacy of romiplostim in patients with chronic immune thrombocytopenic purpura: a double-blind randomised controlled trial". Lancet.
  3. (2009). "Romiplostim". Drugs.
  4. (October 2006). "AMG 531, a thrombopoiesis-stimulating protein, for chronic ITP". The New England Journal of Medicine.
  5. (12 March 2008). "Amgen to Discuss Romiplostim BLA". drugs.com.
  6. (4 September 2008). "FDA Approvals: Nplate, Aloxi, Vidaza". [[Medscape]].
  7. (22 August 2008). "FDA Approves Nplate for Long-Term Treatment of Adult Chronic ITP". Amgen.
  8. (May 2009). "Romiplostim: a novel thrombopoiesis-stimulating agent". American Journal of Health-System Pharmacy.
  9. (5 October 2022). "US splashes $290m on anti-radiation drugs after Putin ups nuclear threats". The Daily Telegraph.
Info: Wikipedia Source

This article was imported from Wikipedia and is available under the Creative Commons Attribution-ShareAlike 4.0 License. Content has been adapted to SurfDoc format. Original contributors can be found on the article history page.

antihemorrhagics orphan-drugs thrombopoietin-receptor-agonists
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