Romiplostim
{{Short description|Pharmaceutical drug}}
{{Use dmy dates|date=May 2024}}
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{{Drugbox
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| verifiedrevid = 464383473
| image = Nplate (Romiplostim) 250mkg.jpg
| alt =
| tradename = Nplate, others
| Drugs.com = {{drugs.com|monograph|romiplostim}}
| MedlinePlus = a609008
| DailyMedID = Romiplostim
| pregnancy_AU = B3
| pregnancy_category =
| routes_of_administration = Subcutaneous
| ATC_prefix = B02
| ATC_suffix = BX04
| ATC_supplemental =
| legal_AU = S4
| legal_CA =
| legal_UK =
| legal_US = Rx-only
| legal_EU = Rx-only
| legal_EU_comment = {{cite web | title=Nplate EPAR | website=European Medicines Agency (EMA) | date=27 May 2005 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/nplate | access-date=16 May 2024}} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
| legal_status =
| bioavailability =
| protein_bound =
| metabolism =
| elimination_half-life = 1 to 34 days
| excretion =
| CAS_number_Ref = {{cascite|changed|??}}
| CAS_number = 267639-76-9
| PubChem =
| IUPHAR_ligand = 6974
| DrugBank_Ref = {{drugbankcite|correct|drugbank}}
| DrugBank = DB05332
| ChemSpiderID_Ref = {{chemspidercite|changed|chemspider}}
| ChemSpiderID = none
| UNII_Ref = {{fdacite|correct|FDA}}
| UNII = GN5XU2DXKV
| KEGG = D08990
| ChEMBL_Ref = {{ebicite|correct|EBI}}
| ChEMBL = 1201832
| synonyms = AMG531
| IUPAC_name = L-methionyl[human immunoglobulin heavy constant gamma 1-(227 C-terminal residues)-peptide (Fc fragment)] fusion protein with 41 amino acids peptide, (7-7′:10,10′)-bisdisulfide dimer
| C=2634 | H=4086 | N=722 | O=790 | S=18
}}
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).{{cite journal | vauthors = Kuter DJ, Bussel JB, Lyons RM, Pullarkat V, Gernsheimer TB, Senecal FM, Aledort LM, George JN, Kessler CM, Sanz MA, Liebman HA, Slovick FT, de Wolf JT, Bourgeois E, Guthrie TH, Newland A, Wasser JS, Hamburg SI, Grande C, Lefrère F, Lichtin AE, Tarantino MD, Terebelo HR, Viallard JF, Cuevas FJ, Go RS, Henry DH, Redner RL, Rice L, Schipperus MR, Guo DM, Nichol JL | title = Efficacy of romiplostim in patients with chronic immune thrombocytopenic purpura: a double-blind randomised controlled trial | journal = Lancet | volume = 371 | issue = 9610 | pages = 395–403 | date = February 2008 | pmid = 18242413 | doi = 10.1016/S0140-6736(08)60203-2 | s2cid = 23827197 }}
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.{{cite journal | vauthors = Frampton JE, Lyseng-Williamson KA | title = Romiplostim | journal = Drugs | volume = 69 | issue = 3 | pages = 307–317 | date = 2009 | pmid = 19275274 | doi = 10.2165/00003495-200969030-00006 }}
History
Romiplostim was developed by Amgen through a restricted usage program called NEXUS. During development and clinical trials the drug was called AMG531.{{cite journal | vauthors = Bussel JB, Kuter DJ, George JN, McMillan R, Aledort LM, Conklin GT, Lichtin AE, Lyons RM, Nieva J, Wasser JS, Wiznitzer I, Kelly R, Chen CF, Nichol JL | title = AMG 531, a thrombopoiesis-stimulating protein, for chronic ITP | journal = The New England Journal of Medicine | volume = 355 | issue = 16 | pages = 1672–1681 | date = October 2006 | pmid = 17050891 | doi = 10.1056/NEJMoa054626 | doi-access = free }}
Romiplostim was designated an orphan drug by the US Food and Drug Administration (FDA) in 2003{{cite web | url=https://www.drugs.com/nda/romiplostim_080312.html | title=Amgen to Discuss Romiplostim BLA | date=12 March 2008 | access-date=4 November 2008 | publisher=drugs.com}}
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.{{cite web |url=http://www.medscape.com/viewarticle/580032 |title=FDA Approvals: Nplate, Aloxi, Vidaza | vauthors = Waknine Y |date=4 September 2008 |access-date=4 September 2008 |publisher=Medscape}}{{cite press release |url=http://www.amgen.com/media/pr.jsp?year=2008 |title=FDA Approves Nplate for Long-Term Treatment of Adult Chronic ITP |date=22 August 2008 |access-date=4 September 2008 |publisher=Amgen |archive-date=15 September 2008 |archive-url=https://web.archive.org/web/20080915062913/http://www.amgen.com/media/pr.jsp?year=2008 |url-status=dead }}
Society and culture
= Economics =
The wholesale cost of romiplostim if administered weekly is currently estimated at US$55,250 per year.{{cite journal | vauthors = Perreault S, Burzynski J | title = Romiplostim: a novel thrombopoiesis-stimulating agent | journal = American Journal of Health-System Pharmacy | volume = 66 | issue = 9 | pages = 817–824 | date = May 2009 | pmid = 19386944 | doi = 10.2146/ajhp080524 }}
Research
Romiplostim may be used to treat acute radiation syndrome.{{cite news | vauthors = Roberts L |title=US splashes $290m on anti-radiation drugs after Putin ups nuclear threats |url=https://www.telegraph.co.uk/world-news/2022/10/05/us-denies-purchase-radiation-injury-drugs-response-russian-nuclear/ |access-date=10 October 2022 |publisher=The Daily Telegraph |date=5 October 2022}} "To reduce radiation-induced bleeding, Nplate stimulates the body’s production of platelets. The drug can be used to treat adults and children."
References
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