Nplate

Romiplostim
Clinical data

AHFS/Drugs.com	Consumer Drug Information
MedlinePlus	a609008
License data	US FDA: Nplate
Pregnancy category	US: C (Risk not ruled out)
Routes of administration	Subcutaneous injection
ATC code	B02BX04 (WHO)
Legal status
Legal status	US: ℞-only
Pharmacokinetic data
Biological half-life	1 to 34 days
Identifiers
IUPAC name L-methionyl[human immunogloblin 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
ChemSpider	none
UNII	GN5XU2DXKV
ChEMBL	CHEMBL1201832^N
Chemical and physical data
Formula	C₂₆₃₄H₄₀₈₆N₇₂₂O₇₉₀S₁₈
Molar mass	59 kg/mol
^NY (what is this?)

Romiplostim (rINN, USAN) is a fusion protein analog of thrombopoietin, a hormone that regulates platelet production.

The drug was developed by Amgen and is marketed under the trade name Nplate through a restricted usage program called NEXUS. During development and clinical trials the drug was called AMG531.

Romiplostim is indicated as a potential treatment for chronic idiopathic (immune) thrombocytopenic purpura (ITP). Romiplostim was designated an orphan drug by the U.S. Food and Drug Administration (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). The wholesale cost of romiplostim if administered weekly is currently estimated at US $55,250 per year.

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 corticosteroids, intravenous immunoglobulin, Rho(D) immune globulin or splenectomy.

Romiplostim treatment is generally administered at weekly intervals via subcutaneous injection. Prior to injection, a complete blood count (CBC) is obtained, as the dosage is dependent on the individual's body weight and platelet count at the time of treatment. The goal of treatment is to maintain the count above 50,000 per cubic millimeter (mm³) of blood, not to achieve a normal count—defined as 150,000–450,000 per mm³ 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 bleeding diathesis.

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Wikipedia