Romiplostim: Difference between revisions

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			{{Short description\|Pharmaceutical drug}}
			{{Use dmy dates\|date=May 2024}}
			{{cs1 config \|name-list-style=vanc \|display-authors=6}}
	{{Drugbox		{{Drugbox
	\| Verifiedfields = changed		\| Verifiedfields = changed
	\| Watchedfields = changed		\| Watchedfields = changed
	\| verifiedrevid = ~~413115015~~		\| verifiedrevid = 464383473
			\| image = Nplate (Romiplostim) 250mkg.jpg
⚫	\| IUPAC_name = <small>L</small>-methionyl fusion protein with 41 amino acids peptide, (7-7′:10,10′)-bisdisulfide dimer
	\| ~~image~~ =		\| alt =

	<!--Clinical data-->		<!-- Clinical data -->
	\| tradename =		\| tradename = Nplate, others
	\| Drugs.com = {{drugs.com\|~~CDI~~\|romiplostim}}		\| Drugs.com = {{drugs.com\|monograph\|romiplostim}}
	\| MedlinePlus = a609008		\| MedlinePlus = a609008
			\| DailyMedID = Romiplostim
	\| licence_US = Nplate
	\| pregnancy_AU = ~~<!-- A / B1 / B2 /~~ B3 ~~/ C / D / X -->~~		\| pregnancy_AU = B3
	\| ~~pregnancy_US~~ = C		\| pregnancy_category =
		⚫	\| routes_of_administration = ]
	\| pregnancy_category =
			\| ATC_prefix = B02
	\| legal_AU = <!-- S2, S3, S4, S5, S6, S7, S8, S9 or Unscheduled-->
			\| ATC_suffix = BX04
			\| ATC_supplemental =

			\| legal_AU = S4
	\| legal_CA = <!-- Schedule I, II, III, IV, V, VI, VII, VIII -->		\| legal_CA = <!-- Schedule I, II, III, IV, V, VI, VII, VIII -->
	\| legal_UK = <!-- GSL, P, POM, CD, or Class A, B, C -->		\| legal_UK = <!-- GSL, P, POM, CD, or Class A, B, C -->
	\| legal_US = Rx-only		\| legal_US = Rx-only
	\| ~~legal_status~~ =		\| legal_EU = Rx-only
			\| 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>
⚫	\| routes_of_administration = ]
			\| legal_status =

	<!--Pharmacokinetic data-->		<!-- Pharmacokinetic data -->
	\| bioavailability =		\| bioavailability =
	\| protein_bound =		\| protein_bound =
	\| metabolism =		\| metabolism =
	\| elimination_half-life = 1 to 34 days		\| elimination_half-life = 1 to 34 days
	\| excretion =		\| excretion =

	<!--Identifiers-->		<!-- Identifiers -->
	\| ~~ChemSpiderID_Ref~~ = {{~~chemspidercite~~\|changed\|~~chemspider~~}}		\| CAS_number_Ref = {{cascite\|changed\|??}}
⚫	\| ChemSpiderID = NA
⚫	\| ~~CAS_number_Ref~~ = {{~~cascite~~\|correct\|??}}
	\| CAS_number = 267639-76-9		\| CAS_number = 267639-76-9
	\| ~~ATC_prefix~~ = ~~B02~~		\| PubChem =
	\| ~~ATC_suffix~~ = ~~BX04~~		\| IUPHAR_ligand = 6974
	\| 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>
	\| PubChem =
	\| DrugBank_Ref = {{drugbankcite\|correct\|drugbank}}		\| DrugBank_Ref = {{drugbankcite\|correct\|drugbank}}
	\| DrugBank =		\| DrugBank = DB05332
	\| ~~UNII_Ref~~ = {{~~fdacite~~\|changed\|~~FDA~~}}		\| ChemSpiderID_Ref = {{chemspidercite\|changed\|chemspider}}
		⚫	\| ChemSpiderID = none
		⚫	\| UNII_Ref = {{fdacite\|correct\|FDA}}
	\| UNII = GN5XU2DXKV		\| UNII = GN5XU2DXKV
			\| KEGG = D08990
	\| ChEMBL_Ref = {{ebicite\|changed\|EBI}}		\| ChEMBL_Ref = {{ebicite\|changed\|EBI}}
	\| ChEMBL = 1201832		\| ChEMBL = 1201832
			\| synonyms = AMG531

	<!--Chemical data-->		<!-- Chemical data -->
		⚫	\| IUPAC_name = <small>L</small>-methionyl fusion protein with 41 amino acids peptide, (7-7′:10,10′)-bisdisulfide dimer
	\| C=2634 \| H=4086 \| N=722 \| O=790 \| S=18		\| C=2634 \| H=4086 \| N=722 \| O=790 \| S=18
	\| molecular_weight = 59 ]
	}}		}}
	'''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.

			'''Romiplostim''', sold under the brand name '''Nplate''' among others, is a ] analog of ], a ] that regulates ] production.
	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> The wholesale cost of romiplostim if administered weekly is currently estimated at US $55,250 per year.<ref> Am J Health Syst Pharm. 2009 May 1;66(9):817-24. Perreault S, Burzynski J.</ref>

			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" />
⚫	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>

			== Medical uses ==
	==Treatment regimen==
			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>
	Romiplostim treatment is generally administered at weekly intervals via ]. Prior to injection, a ] (CBC) is obtained, as the dosage is dependent on the individual's body weight and ] at the time of treatment. The goal of treatment is to maintain the count above 50,000 per cubic millimeter (mm<sup>3</sup>) 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 count of 200,000 or higher is achieved for two consecutive 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 ].

	==Clinical efficacy==		==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.<ref ~~name~~=~~"romi">~~Frampton JE, Lyseng-Williamson KA..Drugs ~~2009;~~69(3~~):307-317.~~doi: 10.2165/00003495-200969030-00006.</ref>		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>

	==~~Side-effects~~==		== History ==
			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>
	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 ].

			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>
⚫	==References==

		⚫	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>

			== Society and culture ==
			=== Economics ===
			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>

			== Research ==
			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" />

		⚫	== References ==
	{{reflist}}		{{reflist}}

	{{Antihemorrhagics}}		{{Antihemorrhagics}}
			{{Cytokine receptor modulators}}
			{{Portal bar \| Medicine}}
			{{Authority control}}

	]		]
	]		]
			]


	{{blood-drug-stub}}

	]

Latest revision as of 14:56, 14 June 2024

Pharmaceutical drug

Pharmaceutical compound

Romiplostim
Clinical data

Trade names	Nplate, others
Other names	AMG531
AHFS/Drugs.com	Monograph
MedlinePlus	a609008
License data	US DailyMed: Romiplostim
Pregnancy category	AU: B3
Routes of administration	Subcutaneous
ATC code	B02BX04 (WHO)
Legal status
Legal status	AU: S4 (Prescription only) US: ℞-only EU: Rx-only
Pharmacokinetic data
Elimination half-life	1 to 34 days
Identifiers
IUPAC name L-methionyl fusion protein with 41 amino acids peptide, (7-7′:10,10′)-bisdisulfide dimer
CAS Number	267639-76-9
IUPHAR/BPS	6974
DrugBank	DB05332
ChemSpider	none
UNII	GN5XU2DXKV
KEGG	D08990
ChEMBL	ChEMBL1201832
Chemical and physical data
Formula	C₂₆₃₄H₄₀₈₆N₇₂₂O₇₉₀S₁₈
Molar mass	59085.01 g·mol
(what is this?) (verify)

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. During development and clinical trials the drug was called AMG531.

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

^ "Nplate EPAR". European Medicines Agency (EMA). 27 May 2005. Retrieved 16 May 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
Kuter DJ, Bussel JB, Lyons RM, Pullarkat V, Gernsheimer TB, Senecal FM, et al. (February 2008). "Efficacy of romiplostim in patients with chronic immune thrombocytopenic purpura: a double-blind randomised controlled trial". Lancet. 371 (9610): 395–403. doi:10.1016/S0140-6736(08)60203-2. PMID 18242413. S2CID 23827197.
Frampton JE, Lyseng-Williamson KA (2009). "Romiplostim". Drugs. 69 (3): 307–317. doi:10.2165/00003495-200969030-00006. PMID 19275274.
^ Waknine Y (4 September 2008). "FDA Approvals: Nplate, Aloxi, Vidaza". Medscape. Retrieved 4 September 2008.
Bussel JB, Kuter DJ, George JN, McMillan R, Aledort LM, Conklin GT, et al. (October 2006). "AMG 531, a thrombopoiesis-stimulating protein, for chronic ITP". The New England Journal of Medicine. 355 (16): 1672–1681. doi:10.1056/NEJMoa054626. PMID 17050891.
"Amgen to Discuss Romiplostim BLA". drugs.com. 12 March 2008. Retrieved 4 November 2008.
"FDA Approves Nplate for Long-Term Treatment of Adult Chronic ITP" (Press release). Amgen. 22 August 2008. Archived from the original on 15 September 2008. Retrieved 4 September 2008.
Perreault S, Burzynski J (May 2009). "Romiplostim: a novel thrombopoiesis-stimulating agent". American Journal of Health-System Pharmacy. 66 (9): 817–824. doi:10.2146/ajhp080524. PMID 19386944.
^ Roberts L (5 October 2022). "US splashes $290m on anti-radiation drugs after Putin ups nuclear threats". The Daily Telegraph. Retrieved 10 October 2022.

Antihemorrhagics (B02)

Antihemorrhagics
(coagulation)

Systemic

Vitamin K

Coagulation
factors

intrinsic:
VIII/(Damoctocog alfa pegol, Efanesoctocog alfa, Efmoroctocog alfa, Moroctocog alfa, Susoctocog alfa, Turoctocog alfa, Valoctocogene roxaparvovec, von Willebrand factor)
IX/(Fidanacogene elaparvovec, Nonacog alfa)

extrinsic: VII/Eptacog alfa

combinations: Prothrombin complex concentrate (II, VII, IX, X, protein C and S)

Other
systemic

Local

Antifibrinolytics

Cytokine receptor modulators

Chemokine

See here instead.

CSF

Erythropoietin	Agonists: ARA-290 Asialo erythropoietin Carbamylated erythropoietin CNTO-530 Darbepoetin alfa Epoetin alfa Epoetin beta Epoetin delta Epoetin epsilon Epoetin gamma Epoetin kappa Epoetin omega Epoetin theta Epoetin zeta Erythropoietin (EPO) Erythropoietin-Fc Methoxy polyethylene glycol-epoetin beta (CERA/Mircera) Peginesatide Pegol sihematide (EPO-018B)
G-CSF (CSF3)	Agonists: Filgrastim Granulocyte colony-stimulating factor Lenograstim Leridistim Lipegfilgrastim Nartograstim Pegfilgrastim Pegnartograstim
GM-CSF (CSF2)	Agonists: Ecogramostim Granulocyte macrophage colony-stimulating factor Milodistim Molgramostim Regramostim Sargramostim Antibodies: Mavrilimumab Namilumab Otilimab
M-CSF (CSF1)	Agonists: Cilmostim Interleukin-34 Lanimostim Macrophage colony-stimulating factor Mirimostim Kinase inhibitors: Agerafenib
SCF (c-Kit)	See here instead.
Thrombopoietin	Agonists: Eltrombopag Pegacaristim Promegapoietin Romiplostim Thrombopoietin (THPO, MGDF)

Interferon

IFNAR (α/β, I)

Decoy receptors: Bifarcept

IFNGR (γ, II)

Agonists: Interferon gamma (IFN-γ)
Interferon gamma 1b

Antibodies: Emapalumab
Fontolizumab

IFNLR (λ, III)

See IL-28R (IFNLR) here instead.

Interleukin

See here instead.

TGFβ

See here instead.

TNF

See here instead.

Others

JAK
(inhibitors)

JAK1	Abrocitinib Baricitinib Deuruxolitinib Filgotinib Momelotinib Oclacitinib Peficitinib Ruxolitinib Tofacitinib (tasocitinib) Upadacitinib
JAK2	Atiprimod AZD-1480 Baricitinib CHZ868 Cucurbitacin I (elatericin B, JSI-124) CYT387 Deuruxolitinib Lestaurtinib NSC-7908 NSC-33994 Pacritinib Peficitinib Ruxolitinib SD-1008 Tofacitinib (tasocitinib)
JAK3	Cercosporamide Decernotinib (VX-509) Peficitinib Ritlecitinib TCS-21311 Tofacitinib (tasocitinib) WHI-P 154 ZM-39923 ZM-449829
TYK2	Deucravacitinib

Others

Additional cytokines: Cardiotrophin 1 (CT-1)
FMS-like tyrosine kinase 3 ligand (FLT3L)
Leukemia/leukocyte inhibitory factor (LIF)
Oncostatin M (OSM)
Thymic stromal lymphopoietin (TSLP)

Additional cytokine receptor modulators: Emfilermin
Lestaurtinib
Midostaurin
Quizartinib
Sorafenib
Sunitinib

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Medicine

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