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Filgrastim

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Not to be confused with granulocyte-macrophage colony-stimulating factor or epoetin alfa.

Filgrastim
Clinical data
Trade namesNeupogen, others
Other namesXM02
Biosimilarsfilgrastim-aafi,[1] filgrastim-ayow,[2] filgrastim-sndz, filgrastim-txid[3] Accofil,[4] Biograstim,[5] Fraven, Grastofil,[6] Nivestim,[7] Nivestym,[8] Nypozi,[3][9] Ratiograstim,[10] Releuko,[2] Tevagrastim, Zarxio,[11] Zarzio[12]
AHFS/Drugs.comMonograph
MedlinePlusa692033
License data
Pregnancy
category
Routes of
administration		Intraveneous, subcutaneous
Drug classHematopoietic agents, colony-stimulating factors
ATC code
Legal status
Legal status
Identifiers
  • Human granulocyte colony stimulating factor
CAS Number
IUPHAR/BPS
DrugBank
ChemSpider
  • none
UNII
KEGG
ChEMBL
ECHA InfoCard100.167.401 Edit this at Wikidata
Chemical and physical data
FormulaC845H1343N223O243S9
Molar mass18802.90 g·mol−1

Filgrastim, sold under the brand name Neupogen among others, is a medication used to treat low neutrophil count.[19] Low neutrophil counts may occur with HIV/AIDS, following chemotherapy or radiation poisoning, or be of an unknown cause.[19] It may also be used to increase white blood cells for gathering during leukapheresis.[19] It is given either by injection into a vein or under the skin.[19] Filgrastim is a leukocyte growth factor.[18]

Common side effects include fever, cough, chest pain, joint pain, vomiting, and hair loss.[19] Severe side effects include splenic rupture and allergic reactions.[19] It is unclear if use in pregnancy is safe for the baby.[19] Filgrastim is a recombinant form of the naturally occurring granulocyte colony-stimulating factor (G-CSF).[19] It works by stimulating the body to increase neutrophil production.[19]

Filgrastim was approved for medical use in the United States in 1991.[19] It is on the World Health Organization's List of Essential Medicines.[20][21] Filgrastim biosimilar medications are available.[19]

Medical uses

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Filgrastim is used to treat neutropenia;[18] acute myeloid leukemia;[18] nonmyeloid malignancies;[18] leukapheresis;[18] congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia;[18] and myelosuppressive doses of radiation.[18][22]

Tbo-filgrastim (Granix) is indicated for reduction in the duration of severe neutropenia in people with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.[23]

Adverse effects

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The most commonly observed adverse effect is mild bone pain after repeated administration,[24] and local skin reactions at the site of injection.[18] Other observed adverse effects include serious allergic reactions (including a rash over the whole body,[25] shortness of breath, wheezing, dizziness, swelling around the mouth or eyes, fast pulse, and sweating), ruptured spleen (sometimes resulting in death),[26] alveolar hemorrhage, acute respiratory distress syndrome, and hemoptysis.[18] Severe sickle cell crises, in some cases resulting in death, have been associated with the use of filgrastim in people with sickle cell disorders.[18]

Interactions

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Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone imaging changes; this should be considered when interpreting bone-imaging results.[18]

Mechanism of action

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G-CSF is a colony stimulating factor which has been shown to have minimal direct in vivo or in vitro effects on the production of other haematopoietic cell types. Neupogen (filgrastim) is the name for recombinant methionyl human granulocyte colony stimulating factor (r-metHuG-CSF).[18]

Society and culture

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Biosimilars

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See also: Biosimilars

In 2015, Sandoz's filgrastim-sndz (Zarxio), obtained the approval of the US Food and Drug Administration (FDA) as a biosimilar.[11][27][28] This was the first product to be passed under the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), as part of the Affordable Care Act.[11] Zarxio was approved as a biosimilar, not as an interchangeable product, the FDA notes. And under the BPCI Act, only a biologic that has been approved as an "interchangeable" may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product. The FDA said its approval of Zarxio is based on review of evidence that included structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Zarxio is biosimilar to Neupogen.[28]

In 2018, filgrastim-aafi (Nivestym) was approved for use in the United States.[1]

In September 2008, Ratiograstim, Tevagrastim, Biograstim, and Filgrastim ratiopharm were approved for use in the European Union.[10][29][5][30] Filgrastim ratiopharm was withdrawn in July 2011 and Biograstim was withdrawn in December 2016.

In February 2009, Filgrastim Hexal and Zarzio were approved for use in the European Union.[31][12]

In June 2010, Nivestim was approved for use in the European Union.[7]

In October 2013, Grastofil was approved for use in the European Union.[6]

In September 2014, Accofil was approved for use in the European Union.[4]

In 2016, Fraven was approved for use by Republic of Turkey ministry of health.[32][33]

Nivestym was approved for medical use in Canada in April 2020.[8]

In October 2021, Nypozi was approved for medical use in Canada.[9]

In February 2022, filgrastim-ayow (Releuko) was approved for medical use in the United States.[2][34]

In June 2024, filgrastim-txid (Nypozi) was approved for medical use in the United States.[3]

In December 2024, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Zefylti, intended for the treatment of neutropenia and the mobilization of peripheral blood progenitor cells.[35] The applicant for this medicinal product is CuraTeQ Biologics s.r.o.[35] Zefylti is a biosimilar medicinal product.[35] It is highly similar to the reference product Neupogen (filgrastim), which has been authorized in various EU countries.[35]

Economics

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Shortly after it was introduced, analyses of whether filgrastim is a cost-effective way of preventing febrile neutropenia depended upon the clinical situation and the financial model used to pay for treatment.[36] The longer-acting pegfilgrastim may in some cases be more cost-effective.[37]

References

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  1. ^ a b "Drug Approval Package: Nivestym (filgrastim-aafi)". U.S. Food and Drug Administration (FDA). 21 February 2019. Archived from the original on 20 December 2019. Retrieved 20 December 2019.
  2. ^ a b c "Releuko- filgrastim injection, solution". DailyMed. 11 March 2022. Archived from the original on 17 March 2022. Retrieved 16 March 2022.
  3. ^ a b c https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761126s000lbl.pdf [bare URL PDF]
  4. ^ a b "Accofil EPAR". European Medicines Agency (EMA). 17 September 2018. Archived from the original on 23 March 2020. Retrieved 2 April 2020.
  5. ^ a b "Biograstim EPAR". European Medicines Agency (EMA). 17 September 2018. Archived from the original on 22 October 2020. Retrieved 2 April 2020.
  6. ^ a b "Grastofil EPAR". European Medicines Agency (EMA). 17 September 2018. Archived from the original on 12 November 2020. Retrieved 2 April 2020.
  7. ^ a b c "Nivestim EPAR". European Medicines Agency (EMA). 17 September 2018. Archived from the original on 20 December 2019. Retrieved 20 December 2019.
  8. ^ a b "Summary Basis of Decision (SBD) for Nivestym". Health Canada. 23 October 2014. Archived from the original on 30 May 2022. Retrieved 29 May 2022.
  9. ^ a b "Summary Basis of Decision (SBD) for Nypozi". Health Canada. 23 October 2014. Archived from the original on 25 September 2022. Retrieved 29 May 2022.
  10. ^ a b "Ratiograstim EPAR". European Medicines Agency (EMA). 17 September 2018. Archived from the original on 14 August 2020. Retrieved 2 April 2020.
  11. ^ a b c "FDA approves first biosimilar product Zarxio". U.S. Food and Drug Administration (FDA) (Press release). 6 March 2015. Archived from the original on 11 December 2015. Retrieved 23 November 2015.
  12. ^ a b "Zarzio EPAR". European Medicines Agency (EMA). 17 September 2018. Archived from the original on 15 October 2019. Retrieved 20 December 2019.
  13. ^ "Filgrastim Use During Pregnancy". Drugs.com. 13 September 2018. Archived from the original on 18 December 2019. Retrieved 17 December 2019.
  14. ^ "Health product highlights 2021: Annexes of products approved in 2021". Health Canada. 3 August 2022. Retrieved 25 March 2024.
  15. ^ "Neupogen 30 MU (0.3 mg/ml) solution for injection - Summary of Product Characteristics (SmPC)". (emc). 7 May 2021. Archived from the original on 1 March 2022. Retrieved 1 March 2022.
  16. ^ "Zarzio 30 MU/0.5 ml solution for injection or infusion in pre-filled syringe - Summary of Product Characteristics (SmPC)". (emc). 4 July 2019. Archived from the original on 20 December 2019. Retrieved 20 December 2019.
  17. ^ "Nivestim 12 MU/ 0.2 ml solution for injection/infusion - Summary of Product Characteristics (SmPC)". (emc). 18 December 2019. Archived from the original on 20 December 2019. Retrieved 20 December 2019.
  18. ^ a b c d e f g h i j k l m "Neupogen- filgrastim injection, solution". DailyMed. 15 November 2019. Archived from the original on 25 November 2020. Retrieved 20 December 2019.
  19. ^ a b c d e f g h i j k "Filgrastim". The American Society of Health-System Pharmacists. Archived from the original on 10 May 2017. Retrieved 8 December 2016.
  20. ^ World Health Organization (2019). World Health Organization model list of essential medicines: 21st list 2019. Geneva: World Health Organization. hdl:10665/325771. WHO/MVP/EMP/IAU/2019.06. License: CC BY-NC-SA 3.0 IGO.
  21. ^ World Health Organization (2021). World Health Organization model list of essential medicines: 22nd list (2021). Geneva: World Health Organization. hdl:10665/345533. WHO/MHP/HPS/EML/2021.02.
  22. ^ "FDA Approves Radiation Medical Countermeasure". U.S. Food and Drug Administration (FDA). 30 March 2015. Retrieved 8 September 2023.
  23. ^ "Granix- tbo-filgrastim injection, solution". DailyMed. 30 November 2019. Retrieved 8 September 2023.
  24. ^ Moore DC, Pellegrino AE (September 2017). "Pegfilgrastim-Induced Bone Pain: A Review on Incidence, Risk Factors, and Evidence-Based Management". The Annals of Pharmacotherapy. 51 (9): 797–803. doi:10.1177/1060028017706373. PMID 28423916. S2CID 33032446.
  25. ^ Scott WR, Silberstein L, Flatley R, Ardeshna KM, Korostoff N, Dawe S (September 2009). "Cutaneous reaction to pegfilgrastim presenting as severe generalized skin eruption". The British Journal of Dermatology. 161 (3): 717–719. doi:10.1111/j.1365-2133.2009.09371.x. PMID 19614649. S2CID 2655192.
  26. ^ Zimmer BM, Berdel WE, Ludwig WD, Notter M, Reufi B, Thiel E (March 1993). "Fatal spleen rupture during induction chemotherapy with rh GM-CSF priming for acute monocytic leukemia. Clinical case report and in vitro studies". Leukemia Research. 17 (3): 277–283. doi:10.1016/0145-2126(93)90012-a. PMID 8450676.
  27. ^ "Zarxio (filgrastim-sndz)". U.S. Food and Drug Administration (FDA). 20 April 2015. Archived from the original on 20 December 2019. Retrieved 20 December 2019.
  28. ^ a b Tavernise S, Pollack A (6 March 2015). "F.D.A. Approves Zarxio, Its First Biosimilar Drug". The New York Times. Archived from the original on 23 October 2015. Retrieved 23 November 2015.
  29. ^ "Tevagrastim EPAR". European Medicines Agency (EMA). 17 September 2018. Archived from the original on 16 October 2019. Retrieved 2 April 2020.
  30. ^ "Filgrastim ratiopharm EPAR". European Medicines Agency (EMA). 17 September 2018. Archived from the original on 21 January 2021. Retrieved 2 April 2020.
  31. ^ "Filgrastim Hexal EPAR". European Medicines Agency (EMA). 17 September 2018. Archived from the original on 30 December 2019. Retrieved 2 April 2020.
  32. ^ "Arven ilaç, Türkiyenin ilk biyobenzer ürününü üretti" [Arven Pharmaceuticals produced Turkey's first biosimilar product]. Vatan Finans (in Turkish). Archived from the original on 11 February 2023.
  33. ^ "Products". Arven İlaç. Retrieved 30 August 2024.
  34. ^ "Drug Approval Package: Releuko". U.S. Food and Drug Administration (FDA). 11 April 2022. Retrieved 2 July 2024.
  35. ^ a b c d "Zefylti EPAR". European Medicines Agency (EMA). 12 December 2024. Retrieved 16 December 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  36. ^ Neymark N (1998). Assessing the Economic Value of Anticancer Therapies. Recent Results in Cancer Research. Vol. 148. Berlin, Heidelberg: Springer. pp. 215–219. doi:10.1007/978-3-642-72123-6. ISBN 978-3-642-72123-6. OCLC 851760173. PMID 9670279. S2CID 34894897. {{cite book}}: |journal= ignored (help)
  37. ^ Ellery T (2012). Pharmaceutical lifecycle management : making the most of each and every brand. Hansen, Neal. Hoboken, N.J.: John Wiley & Sons. p. 214. ISBN 978-1-118-26679-3. OCLC 797824835.

Further reading

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