Romiplostim

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

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[1]
Pharmacokinetic data
Elimination half-life	1 to 34 days
Identifiers
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
CAS Number	267639-76-9 N
IUPHAR/BPS	6974
DrugBank	DB05332 Y
ChemSpider	none
UNII	GN5XU2DXKV
KEGG	D08990
ChEMBL	ChEMBL1201832 Y
Chemical and physical data
Formula	C2634H4086N722O790S18
Molar mass	59085.01 g·mol−1
NY (what is this?)  (verify)

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]