Pegfilgrastim - Misplaced Pages

(Redirected from Neulasta) Monoclonal antibody

Pharmaceutical compound

Pegfilgrastim
Clinical data
Trade names	Neulasta
Biosimilars	pegfilgrastim-apgf, pegfilgrastim-bmez, pegfilgrastim-cbqv, pegfilgrastim-fpgk, pegfilgrastim-jmdb, pegfilgrastim-pbbk, Armlupeg, Cegfila, Filpegla, Fulphila, Fylnetra, Grasustek, Lapelga, Neutropeg, Niopeg, Nyvepria, Pelgraz, Pelmeg, Ristempa, Stimufend, Tezmota, Udenyca, Ziextenzo
AHFS/Drugs.com	Monograph
MedlinePlus	a607058
License data	EU EMA: by INN US DailyMed: Pegfilgrastim
Pregnancy category	AU: B3
Routes of administration	Subcutaneous
Drug class	Hematopoietic agents, colony-stimulating factors, immunostimulants
ATC code	L03AA13 (WHO)
Legal status
Legal status	AU: S4 (Prescription only) CA: ℞-only / Schedule D UK: POM (Prescription only) US: ℞-only EU: Rx-only 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
IUPHAR/BPS	6969
DrugBank	DB00019
ChemSpider	none
UNII	3A58010674
KEGG	D06889
ChEMBL	ChEMBL1201568
ECHA InfoCard	100.169.155
Chemical and physical data
Formula	C₈₄₅H₁₃₄₃N₂₂₃O₂₄₃S₉
Molar mass	18802.90 g·mol
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Pegfilgrastim, sold under the brand name Neulasta among others, is a PEGylated form of the recombinant human granulocyte colony-stimulating factor (GCSF) analog filgrastim. It serves to stimulate the production of white blood cells (neutrophils). Pegfilgrastim was developed by Amgen.

Pegfilgrastim treatment can be used to stimulate bone marrow to produce more neutrophils to fight infection in patients undergoing chemotherapy.

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

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. It is on the World Health Organization's List of Essential Medicines.

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).

References

"Regulatory Decision Summary for Armlupeg". Drug and Health Products Portal. 16 August 2024. Retrieved 27 December 2024.
^ "Cegfila EPAR". European Medicines Agency (EMA). Archived from the original on 11 June 2020. Retrieved 2 April 2020.
^ "Filpegla | Therapeutic Goods Administration (TGA)". Archived from the original on 18 December 2022. Retrieved 18 December 2022.
^ "Fulphila EPAR". European Medicines Agency (EMA). 24 September 2018. Archived from the original on 11 June 2020. Retrieved 2 April 2020.
^ "Fylnetra- pegfilgrastim injection". DailyMed. 26 May 2022. Archived from the original on 3 July 2022. Retrieved 19 June 2022.
^ "Grasustek EPAR". European Medicines Agency (EMA). 24 April 2019. Archived from the original on 11 June 2020. Retrieved 2 April 2020.
^ "Summary Basis of Decision for Niopeg". Drug and Health Products Portal. 1 September 2012. Retrieved 17 December 2024.
^ "Pelmeg EPAR". European Medicines Agency (EMA). 24 September 2018. Archived from the original on 11 June 2020. Retrieved 2 April 2020.
^ "Stimufend- pegflilgrastim-fpgk injection, solution". DailyMed. 15 September 2022. Archived from the original on 21 January 2023. Retrieved 21 January 2023.
^ "Stimufend EPAR". European Medicines Agency (EMA). Archived from the original on 21 April 2022. Retrieved 4 April 2022.
"Tezmota". NPS MedicineWise. 15 July 2021. Archived from the original on 29 September 2022. Retrieved 19 February 2022.
^ "Ziextenzo EPAR". European Medicines Agency (EMA). 24 September 2018. Archived from the original on 11 June 2020. Retrieved 2 April 2020.
"Summary Basis of Decision (SBD) for Ziextenzo". Health Canada. 23 October 2014. Archived from the original on 30 May 2022. Retrieved 29 May 2022.
^ "Ziextenzo". Therapeutic Goods Administration (TGA). 13 December 2019. Archived from the original on 20 October 2021. Retrieved 25 August 2020.
"Pegfilgrastim Use During Pregnancy". Drugs.com. 9 December 2019. Archived from the original on 5 December 2020. Retrieved 13 July 2020.
"Neulasta Pre-Filled Syringe - Summary of Product Characteristics (SmPC)". (emc). 1 June 2021. Archived from the original on 15 January 2021. Retrieved 11 October 2021.
"Neulasta On Body Injector - Summary of Product Characteristics (SmPC)". (emc). Archived from the original on 17 January 2021. Retrieved 11 October 2021.
^ "Neulasta- pegfilgrastim kit Neulasta- pegfilgrastim injection". DailyMed. Archived from the original on 15 July 2021. Retrieved 14 July 2021.
^ "Neulasta EPAR". European Medicines Agency (EMA). 17 September 2018. Archived from the original on 11 June 2020. Retrieved 2 April 2020.
Walsh, G, Spada, S. "Epogen/Procrit" in: Directory of approved biopharmaceutical products. CRC Press, 2005, pp. 136–37.
^ "Drug Approval Package: Neulasta (Pegfilgrastim) NDA #125031". U.S. Food and Drug Administration (FDA). 25 October 2004. Archived from the original on 30 March 2021. Retrieved 11 June 2020.
^ "Pegfilgrastim Monograph for Professionals". Drugs.com. 22 August 2019. Archived from the original on 7 March 2016. Retrieved 11 June 2020.
Ho, Rodney J. Y.; Gibaldi, Milo, eds. (2004). "Pegfilgrastim". Biotechnology and Biopharmaceuticals: Transforming Proteins and Genes into Drugs. John Wiley & Sons. pp. 157–159. ISBN 978-0-471-45027-6. Archived from the original on 20 October 2021. Retrieved 10 November 2020.
"Summary for ARTG Entry: 82873 Neulasta pegfilgrastim rbe 6mg/0.6mL injection syringe with stelmi needle shield" (PDF). Therapeutic Goods Administration (TGA).
"NEULASTA pegfilgrastim (Rbe) 6mg/0.6mL injection syringe with automatic needle guard (166387) | Therapeutic Goods Administration (TGA)". Archived from the original on 18 December 2022. Retrieved 18 December 2022.
"NEULASTA pegfilgrastim rbe 6mg/0.6mL injection syringe with stelmi needle shield (82873) | Therapeutic Goods Administration (TGA)". Archived from the original on 18 December 2022. Retrieved 18 December 2022.
World Health Organization (2023). The selection and use of essential medicines 2023: web annex A: World Health Organization model list of essential medicines: 23rd list (2023). Geneva: World Health Organization. hdl:10665/371090. WHO/MHP/HPS/EML/2023.02.
Cerchione C, Catalano L, Peluso I, Nappi D, Di Perna M, Salvatore D, et al. (December 2016). "Managing neutropenia by pegfilgrastim in patients affected by relapsed/refractory multiple myeloma treated with bendamustine-bortezomib-dexamethasone". Supportive Care in Cancer. 24 (12): 4835–4837. doi:10.1007/s00520-016-3430-9. PMC 5082581. PMID 27726031.
Parker SD, King N, Jacobs TF (November 2020). "Pegfilgrastim". StatPearls . Treasure Island (FL): StatPearls Publishing. PMID 30422488. Archived from the original on 20 October 2021. Retrieved 5 November 2020.

Immunostimulants (L03)

Endogenous

Cytokines

Colony-stimulating factors	G-CSF Efbemalenograstim alfa Eflapegrastim Filgrastim / Lipegfilgrastim / Pegfilgrastim Lenograstim GM-CSF Molgramostim Sargramostim SCF Ancestim
Interferons	alpha: Albinterferon Interferon alfa natural Interferon alfa 2a / Peginterferon alfa-2a Interferon alfa 2b / Peginterferon alfa-2b / Ropeginterferon alfa-2b Interferon alfa n1 Interferon alfacon-1 Interferon alpha-n3 feline "omega" beta: Interferon beta natural Interferon beta 1a Interferon beta 1b Interferon gamma
Interleukins	Aldesleukin Nogapendekin alfa inbakicept Oprelvekin

Other protein / peptide

Other

Exogenous

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

Growth factor receptor modulators

Angiopoietin

Agonists: Angiopoietin 1
Angiopoietin 4

Antagonists: Angiopoietin 2
Angiopoietin 3

Kinase inhibitors: Altiratinib
CE-245677
Rebastinib

Antibodies: Evinacumab (against angiopoietin 3)
Nesvacumab (against angiopoietin 2)

CNTF

Agonists: Axokine
CNTF
Dapiclermin

EGF (ErbB)

EGF (ErbB1/HER1)	Agonists: Amphiregulin Betacellulin EGF (urogastrone) Epigen Epiregulin Heparin-binding EGF-like growth factor (HB-EGF) Murodermin Nepidermin Transforming growth factor alpha (TGFα) Kinase inhibitors: Afatinib Agerafenib Brigatinib Canertinib Dacomitinib Erlotinib Gefitinib Grandinin Icotinib Lapatinib Neratinib Osimertinib Vandetanib WHI-P 154 Antibodies: Cetuximab Depatuxizumab Depatuxizumab mafodotin Futuximab Imgatuzumab Matuzumab Necitumumab Nimotuzumab Panitumumab Zalutumumab
ErbB2/HER2	Agonists: Unknown/none Antibodies: Ertumaxomab Pertuzumab Trastuzumab Trastuzumab deruxtecan Trastuzumab duocarmazine Trastuzumab emtansine Kinase inhibitors: Afatinib Lapatinib Mubritinib Neratinib Tucatinib
ErbB3/HER3	Agonists: Neuregulins (heregulins) (1, 2, 6 (neuroglycan C)) Antibodies: Duligotumab Patritumab Seribantumab
ErbB4/HER4	Agonists: Betacellulin Epigen Heparin-binding EGF-like growth factor (HB-EGF) Neuregulins (heregulins) (1, 2, 3, 4, 5 (tomoregulin, TMEFF))

FGF

FGFR1	Agonists: Ersofermin FGF (1, 2 (bFGF), 3, 4, 5, 6, 8, 10 (KGF2), 20) Repifermin Selpercatinib Trafermin Velafermin
FGFR2	Agonists: Ersofermin FGF (1, 2 (bFGF), 3, 4, 5, 6, 7 (KGF), 8, 9, 10 (KGF2), 17, 18, 22) Palifermin Repifermin Selpercatinib Sprifermin Trafermin Antibodies: Aprutumab Aprutumab ixadotin Kinase inhibitors: Infigratinib
FGFR3	Agonists: Ersofermin FGF (1, 2 (bFGF), 4, 8, 9, 18, 23) Selpercatinib Sprifermin Trafermin Antibodies: Burosumab (against FGF23)
FGFR4	Agonists: Ersofermin FGF (1, 2 (bFGF), 4, 6, 8, 9, 19) Trafermin
Unsorted	Agonists: FGF15/19

HGF (c-Met)

Agonists: Fosgonimeton
Hepatocyte growth factor

Potentiators: Dihexa (PNB-0408)

IGF

IGF-1

IGF-2

Agonists: Insulin-like growth factor-2 (somatomedin A)

Antibodies: Dusigitumab
Xentuzumab (against IGF-1 and IGF-2)

Others

Binding proteins: IGFBP (1, 2, 3, 4, 5, 6, 7)

Cleavage products/derivatives with unknown target: Glypromate (GPE, (1-3)IGF-1)
Trofinetide

LNGF (p75)

Antibodies: Against NGF: ABT-110 (PG110)
ASP-6294
Fasinumab
Frunevetmab
Fulranumab
MEDI-578
Ranevetmab
Tanezumab

Aptamers: Against NGF: RBM-004

Decoy receptors: LEVI-04 (p75-Fc)

PDGF

Agonists: Becaplermin
Platelet-derived growth factor (A, B, C, D)

RET (GFL)

GFRα1	Agonists: Glial cell line-derived neurotrophic factor (GDNF) Liatermin Kinase inhibitors: Vandetanib
GFRα2	Agonists: Neurturin (NRTN) Kinase inhibitors: Vandetanib
GFRα3	Agonists: Artemin (ARTN) Kinase inhibitors: Vandetanib
GFRα4	Agonists: Persephin (PSPN) Kinase inhibitors: Vandetanib
Unsorted	Kinase inhibitors: Agerafenib