| Revision as of 15:00, 10 February 2011 edit216.1.41.178 (talk) →Clinical efficacy← Previous edit |
Latest revision as of 14:56, 14 June 2024 edit undoActivelyDisinterested (talk | contribs)Extended confirmed users50,435 edits Duplicates {{CS1 config}}, clearing CS1 message |
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{{Short description|Pharmaceutical drug}} |
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{{Use dmy dates|date=May 2024}} |
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{{cs1 config |name-list-style=vanc |display-authors=6}} |
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{{Drugbox |
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{{Drugbox |
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| Verifiedfields = changed |
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| IUPAC_name = <small>L</small>-methionyl fusion protein with 41 amino acids peptide, (7-7′:10,10′)-bisdisulfide dimer |
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| Watchedfields = changed |
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| image = |
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| verifiedrevid = 464383473 |
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| CAS_number = 267639-76-9 |
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| image = Nplate (Romiplostim) 250mkg.jpg |
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| ATC_prefix = B02 |
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| alt = |
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| ATC_suffix = BX04 |
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| ATC_supplemental = <ref>{{cite web |url=http://www.whocc.no/atcddd/new_atc_ddd.html#ATCDDD_TEMPORARY |title=ATC/DDD Classification (TEMPORARY): New ATC 5th level codes |date=August 27, 2008 |author=WHO International Working Group for Drug Statistics Methodology |publisher=WHO Collaborating Centre for Drug Statistics Methodology |accessdate=2008-09-05 |archiveurl = http://web.archive.org/web/20080506023243/http://www.whocc.no/atcddd/new_atc_ddd.html#ATCDDD_TEMPORARY <!-- Bot retrieved archive --> |archivedate = 2008-05-06}}</ref> |
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<!-- Clinical data --> |
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| PubChem = |
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| tradename = Nplate, others |
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| DrugBank = |
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| Drugs.com = {{drugs.com|monograph|romiplostim}} |
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| C=2634|H=4086|N=722|O=790|S=18 |
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| MedlinePlus = a609008 |
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| molecular_weight = 59 ] |
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| DailyMedID = Romiplostim |
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| bioavailability = |
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| protein_bound = |
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| pregnancy_AU = B3 |
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| metabolism = |
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| pregnancy_category = |
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| routes_of_administration = ] |
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| elimination_half-life = 1 to 34 days |
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| ATC_prefix = B02 |
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| excretion = |
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| ATC_suffix = BX04 |
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| pregnancy_AU = <!-- A / B1 / B2 / B3 / C / D / X --> |
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| ATC_supplemental = |
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| pregnancy_US = C |
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| pregnancy_category= |
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| licence_US = Nplate |
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| legal_AU = S4 |
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| legal_AU = <!-- S2, S3, S4, S5, S6, S7, S8, S9 or Unscheduled--> |
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| legal_CA = <!-- Schedule I, II, III, IV, V, VI, VII, VIII --> |
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| legal_CA = <!-- Schedule I, II, III, IV, V, VI, VII, VIII --> |
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| legal_UK = <!-- GSL, P, POM, CD, or Class A, B, C --> |
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| legal_UK = <!-- GSL, P, POM, CD, or Class A, B, C --> |
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| legal_US = Rx-only |
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| legal_US = Rx-only |
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| legal_EU = Rx-only |
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| legal_status = |
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| legal_EU_comment = <ref name="Nplate EPAR">{{cite web | title=Nplate EPAR | website=] (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.</ref> |
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| routes_of_administration = ] |
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| legal_status = |
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}} |
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'''Romiplostim''' (], ]) is a ] analog of ], a ] that regulates ] production. The drug was developed by ] and is marketed under the trade name '''Nplate''' through a restricted usage program called NEXUS.<ref name=Medscape/> During development and ]s the drug was called AMG531. |
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<!-- Pharmacokinetic data --> |
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Romiplostin is indicated as a potential treatment for ] (ITP).<ref name="pmid18242413">{{cite journal |author=Kuter DJ, Bussel JB, Lyons RM, ''et al.'' |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 |year=2008 |month=February |pmid=18242413 |doi=10.1016/S0140-6736(08)60203-2 |url=http://linkinghub.elsevier.com/retrieve/pii/S0140-6736(08)60203-2}}</ref> Romiplostim was designated an ] by the ] (FDA) in 2003, as the chronic ITP population in the USA is under 200,000 (the chronic adult ITP population in the USA is thought to be around 60,000, with women outnumbering men by a factor of two).<ref>{{cite web | url=http://www.drugs.com/nda/romiplostim_080312.html | title=Amgen to Discuss Romiplostim BLA | date=March 12, 2008 | accessdate=2008-11-04 | publisher=drugs.com}}</ref> |
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| bioavailability = |
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| protein_bound = |
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| metabolism = |
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| elimination_half-life = 1 to 34 days |
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| excretion = |
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<!-- Identifiers --> |
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On August 22, 2008, the FDA approved romiplostim as a long-term treatment for chronic ITP in adults who have not responded to other treatments, such as ]s, ], ] or ].<ref name=Medscape>{{cite web |url=http://www.medscape.com/viewarticle/580032 |title=FDA Approvals: Nplate, Aloxi, Vidaza |author=Waknine, Yael |date=September 4, 2008 |accessdate=2008-09-04 |publisher=]}} Freely available with registration.</ref><ref>{{cite press release |url=http://www.amgen.com/media/pr.jsp?year=2008 |title=FDA Approves Nplate(TM) for Long-Term Treatment of Adult Chronic ITP |date=August 22, 2008 |accessdate=2008-09-04 |publisher=Amgen}}</ref> |
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| CAS_number_Ref = {{cascite|changed|??}} |
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| CAS_number = 267639-76-9 |
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| PubChem = |
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| IUPHAR_ligand = 6974 |
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| DrugBank_Ref = {{drugbankcite|correct|drugbank}} |
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| DrugBank = DB05332 |
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| ChemSpiderID_Ref = {{chemspidercite|changed|chemspider}} |
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| ChemSpiderID = none |
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| UNII_Ref = {{fdacite|correct|FDA}} |
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| UNII = GN5XU2DXKV |
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| KEGG = D08990 |
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| ChEMBL_Ref = {{ebicite|changed|EBI}} |
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| ChEMBL = 1201832 |
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| synonyms = AMG531 |
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<!-- Chemical data --> |
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Romiplostim treatment is administered by weekly ]s, using a variable dosage determined by analysis of the patient's ] at the time of treatment. The goal is to maintain the count above 50,000 per cubic millimeter of blood, not to achieve a normal count (defined as 150,000–450,000 per mm<sup>3</sup> in most healthy individuals). If a sustained count of 200,000 or higher is achieved for more than two weeks a reduced dose is administered or treatment is suspended until the count decreases below 200,000. Discontinuation of romiplostim must be approached with great caution, as a rapid decrease in the platelet count may occur, possibly leading to ]. |
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| IUPAC_name = <small>L</small>-methionyl fusion protein with 41 amino acids peptide, (7-7′:10,10′)-bisdisulfide dimer |
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| C=2634 | H=4086 | N=722 | O=790 | S=18 |
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}} |
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'''Romiplostim''', sold under the brand name '''Nplate''' among others, is a ] analog of ], a ] that regulates ] production. |
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Romiplostim's effect is to stimulate the patient's ]s to produce platelets at a more rapid than normal rate, thus overwhelming the ]'s ability to destroy them. As doing so involves changes to the ] chemistry, a number of potentially serious ] may develop, including ], joint and extremity discomfort, ], ], which may lead to potentially fatal ]s, and ], the latter which may result in an ] in the ]. |
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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.<ref name="Nplate EPAR" /> 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.<ref name="Nplate EPAR" /> |
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== Medical uses == |
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Romiplostim is ] as a potential treatment for ] (ITP).<ref name="pmid18242413">{{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 }}</ref> |
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==Clinical efficacy== |
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==Clinical efficacy== |
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In well designed, 24-week, Phase III trials, subcutaneous 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.<ref name="romi">Frampton JE, Lyseng-Williamson KA..Drugs 2009;69(3):307-317.doi: 10.2165/00003495-200969030-00006.</ref> |
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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.<ref>{{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 }}</ref> |
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==References== |
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== History == |
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Romiplostim was developed by ] through a restricted usage program called NEXUS.<ref name=Medscape/> During development and ]s the drug was called AMG531.<ref name="pmid17050891">{{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 }}</ref> |
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Romiplostim was designated an ] by the US ] (FDA) in 2003<ref>{{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}}</ref> |
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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 ]s, ], ] or ].<ref name=Medscape>{{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=]}}</ref><ref>{{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 }}</ref> |
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== Society and culture == |
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=== Economics === |
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The wholesale cost of romiplostim if administered weekly is currently estimated at US$55,250 per year.<ref>{{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 }}</ref> |
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== Research == |
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Romiplostim may be used to treat ].<ref name="Roberts, Telegraph 2022.10.05 - treatment for 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}}</ref> "To reduce radiation-induced bleeding, Nplate stimulates the body’s production of platelets. The drug can be used to treat adults and children."<ref name="Roberts, Telegraph 2022.10.05 - treatment for acute radiation syndrome" /> |
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== References == |
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{{reflist}} |
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{{reflist}} |
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{{Antihemorrhagics}} |
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{{Antihemorrhagics}} |
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{{Cytokine receptor modulators}} |
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{{Portal bar | Medicine}} |
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{{Authority control}} |
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] |
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{{blood-drug-stub}} |
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] |
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