Pegfilgrastim
Monoclonal antibody
From Wikipedia, the free encyclopedia
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]
| 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 | |
| Pregnancy category | |
| Routes of administration | Subcutaneous |
| Drug class | Hematopoietic agents, colony-stimulating factors, immunostimulants |
| ATC code | |
| Legal status | |
| Legal status | |
| Pharmacokinetic data | |
| Elimination half-life | 15–80 hrs |
| Identifiers | |
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| CAS Number | |
| IUPHAR/BPS | |
| DrugBank | |
| ChemSpider |
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| UNII | |
| KEGG | |
| ChEMBL | |
| 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]
