Pegfilgrastim

Pegfilgrastim, sold under the brand name Neulasta among others, is a PEGylated form of the recombinant human granulocyte colony-stimulating factor (GCSF) analog filgrastim.^[22] It serves to stimulate the production of white blood cells (neutrophils).^[22][24] Pegfilgrastim was developed by Amgen.^[25]

Pegfilgrastim

Clinical data
Trade names	Neulasta
Biosimilars	pegfilgrastim-apgf, pegfilgrastim-bmez, pegfilgrastim-cbqv, pegfilgrastim-fpgk, pegfilgrastim-jmdb, pegfilgrastim-pbbk, pegfilgrastim-unne,[1] Armlupeg,[1][2][3] Cegfila,[4] Filpegla,[5] Dyrupeg,[6] Fulphila,[7] Fylnetra,[8] Grasustek,[9] Lapelga, Neutropeg, Niopeg,[10] Nyvepria, Pelgraz, Pelmeg,[11] Ristempa, Stimufend,[12][13] Tezmota,[14] Udenyca, Vivlipeg,[15] Ziextenzo[16][17]
AHFS/Drugs.com	Monograph
MedlinePlus	a607058
License data	US DailyMed: Pegfilgrastim
Pregnancy category	AU: B3[18][5][19]
Routes of administration	Subcutaneous
Drug class	Hematopoietic agents, colony-stimulating factors, immunostimulants
ATC code	L03AA13 (WHO)
Legal status
Legal status	AU: S4 (Prescription only)[18][5] CA: ℞-only / Schedule D[10] UK: POM (Prescription only)[20][21] US: ℞-only[22][8][12] EU: Rx-only[23][16][4][7][11][9][13] In general: ℞ (Prescription only)
Pharmacokinetic data
Elimination half-life	15–80 hrs
Identifiers
IUPAC name N-(3-Hydroxypropyl)Methionylcolony-stimulating Factor (human), 1-Ether with .Alpha.-Methyl-.Omega.-Hydroxypoly(Oxyethylene)
CAS Number	208265-92-3 Y
IUPHAR/BPS	6969
DrugBank	DB00019 Y
ChemSpider	none
UNII	3A58010674
KEGG	D06889 Y
ChEMBL	ChEMBL1201568 N
ECHA InfoCard	100.169.155
Chemical and physical data
Formula	C845H1343N223O243S9
Molar mass	18802.90 g·mol−1
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Pegfilgrastim treatment can be used to stimulate bone marrow to produce more neutrophils to fight infection in patients undergoing chemotherapy.^[26]

Pegfilgrastim has a human half-life of 15 to 80 hours, much longer than the parent filgrastim (3–4 hours).^[27][26]

Pegfilgrastim was approved for medical use in the United States in January 2002, in the European Union in August 2002, and in Australia in September 2002.^{[25][23][28][29][30]} It is on the World Health Organization's List of Essential Medicines.^[31]

Medical uses

Pegfilgrastim is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in people with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia; and to increase survival in people acutely exposed to myelosuppressive doses of radiation (hematopoietic subsyndrome of acute radiation syndrome).^[22][32][33]

Society and culture

Legal status

In January 2025, the Committee for Medicinal Products for Human Use CHMP of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Dyrupeg, intended to shorten the duration of neutropenia and help prevent febrile neutropenia after cytotoxic chemotherapy.^[6] The applicant for this medicinal product is CuraTeQ Biologics s.r.o.^[6] Dyrupeg is a biosimilar medicinal product that is highly similar to the reference product Neulasta, which was authorized in the EU in August 2002.^[6] Dyrupeg was authorized for medical use in the European Union in March 2025.^[6][34]

In June 2025, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Vivlipeg, intended to reduce the duration of neutropenia and the incidence of febrile neutropenia after cytotoxic chemotherapy.^[15] The applicant for this medicinal product is Biosimilar Collaborations Ireland Limited.^[15] Vivlipeg is a biosimilar medicinal product that is highly similar to Neulasta.^[15] Vivlipeg was authorized for medical use in the European Union in August 2025.^[15][35]