Filgrastim

Last updated

Filgrastim
Filgrastim.jpg
Clinical data
Trade names Neupogen, others
Other namesXM02
Biosimilars filgrastim-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.com Monograph
MedlinePlus a692033
License data
Pregnancy
category
Routes of
administration 		Intraveneous, subcutaneous
Drug class Hematopoietic 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 InfoCard 100.167.401 OOjs UI icon edit-ltr-progressive.svg
Chemical and physical data
Formula C845H1343N223O243S9
Molar mass 18802.90 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]

Contents

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

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

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

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

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

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]

Economics

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. [35] The longer-acting pegfilgrastim may in some cases be more cost-effective. [36]

Related Research Articles

<span class="mw-page-title-main">Infliximab</span> Biopharmaceutical drug for autoimmune disorders

Infliximab, a chimeric monoclonal antibody, sold under the brand name Remicade among others, is a medication used to treat a number of autoimmune diseases. This includes Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriasis, psoriatic arthritis, and Behçet's disease. It is given by slow injection into a vein, typically at six- to eight-week intervals.

Etanercept, sold under the brand name Enbrel among others, is a biologic medical product that is used to treat autoimmune diseases by interfering with tumor necrosis factor (TNF), a soluble inflammatory cytokine, by acting as a TNF inhibitor. It has US Food and Drug Administration (FDA) approval to treat rheumatoid arthritis, juvenile idiopathic arthritis and psoriatic arthritis, plaque psoriasis and ankylosing spondylitis. Tumor necrosis factor alpha (TNFα) is the "master regulator" of the inflammatory (immune) response in many organ systems. Autoimmune diseases are caused by an overactive immune response. Etanercept has the potential to treat these diseases by inhibiting TNF-alpha.

<span class="mw-page-title-main">Teriparatide</span> Pharmaceutical drug for treating osteoporosis

Teriparatide, sold under the brand name Forteo, is a form of parathyroid hormone (PTH) consisting of the first (N-terminus) 34 amino acids, which is the bioactive portion of the hormone. It is an effective anabolic agent used in the treatment of some forms of osteoporosis. Teriparatide is a recombinant human parathyroid hormone analog. It has an identical sequence to the 34 N-terminal amino acids of the 84-amino acid human parathyroid hormone.

Bevacizumab, sold under the brand name Avastin among others, is a monoclonal antibody medication used to treat a number of types of cancers and a specific eye disease. For cancer, it is given by slow injection into a vein (intravenous) and used for colon cancer, lung cancer, ovarian cancer, glioblastoma, hepatocellular carcinoma, and renal-cell carcinoma. In many of these diseases it is used as a first-line therapy. For age-related macular degeneration it is given by injection into the eye (intravitreal).

<span class="mw-page-title-main">Insulin glargine</span> Long-acting insulin

Insulin glargine sold under the brand name Lantus among others is a long-acting modified form of medical insulin, used in the management of type I and type II diabetes. It is injected just under the skin. Effects generally begin an hour after use.

Adalimumab, sold under the brand name Humira and others, is a disease-modifying antirheumatic drug and monoclonal antibody used to treat rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis. It is administered by subcutaneous injection. It works by inactivating tumor necrosis factor-alpha (TNFα).

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.

Ranibizumab, sold under the brand name Lucentis among others, is a monoclonal antibody fragment (Fab) created from the same parent mouse antibody as bevacizumab. It is an anti-angiogenic that is approved to treat the "wet" type of age-related macular degeneration, diabetic retinopathy, and macular edema due to branch retinal vein occlusion or central retinal vein occlusion.

Ustekinumab, sold under the brand name Stelara among others, is a monoclonal antibody medication developed by Janssen Pharmaceuticals, for the treatment of Crohn's disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis, targeting both IL-12 and IL-23.

Tocilizumab, sold under the brand name Actemra among others, is an immunosuppressive drug, used for the treatment of rheumatoid arthritis, systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis, giant cell arteritis, cytokine release syndrome, COVID‑19, and systemic sclerosis-associated interstitial lung disease (SSc-ILD). It is a humanized monoclonal antibody against the interleukin-6 receptor (IL-6R). Interleukin 6 (IL-6) is a cytokine that plays an important role in immune response and is implicated in the pathogenesis of many diseases, such as autoimmune diseases, multiple myeloma and prostate cancer. Tocilizumab was jointly developed by Osaka University and Chugai, and was licensed in 2003 by Hoffmann-La Roche.

<span class="mw-page-title-main">Ofatumumab</span> Medication

Ofatumumab is a fully human monoclonal antibody to CD20, which appears to provide rapid B-cell depletion. Under the brand name Kesimpta, it is approved for the treatment of multiple sclerosis in the United States as well as in the European Union and other regions. Under the brand name Arzerra, it is approved for the treatment of certain types of chronic lymphocytic leukemia (CLL) in the United States. It is sold by Novartis under license from Genmab.

<span class="mw-page-title-main">Insulin lispro</span> Rapid-acting insuline analog

Insulin lispro, sold under the brand name Humalog among others, is a modified type of medical insulin used to treat type 1 and type 2 diabetes. It is delivered subcutaneously either by injection or from an insulin pump. Onset of effects typically occurs within 30 minutes and lasts about 5 hours. Often a longer-acting insulin like insulin NPH is also needed.

A biosimilar is a biologic medical product that is almost an identical copy of an original product that is manufactured by a different company. Biosimilars are officially approved versions of original "innovator" products and can be manufactured when the original product's patent expires. Reference to the innovator product is an integral component of the approval.

Aflibercept, sold under the brand names Eylea and Zaltrap, is a medication used to treat wet macular degeneration and metastatic colorectal cancer. It was developed by Regeneron Pharmaceuticals.

<span class="mw-page-title-main">Cabotegravir</span> Medication for HIV/AIDS

Cabotegravir, sold under the brand name Vocabria among others, is a antiretroviral medication used for the treatment of HIV/AIDS. It is available in the form of tablets and as an intramuscular injection, as well as in an injectable combination with rilpivirine under the brand name Cabenuva.

Eptinezumab, sold under the brand name Vyepti, is a medication used for the preventive treatment of migraine in adults. It is a monoclonal antibody that targets calcitonin gene-related peptides (CGRP) alpha and beta. It is administered by intravenous infusion every 3 months.

Lipegfilgrastim, sold under the brand name Lonquex, is a medication used to reduce the duration of neutropenia and the incidence of febrile neutropenia in adults. It is given by injection under the skin in the abdomen, upper arm or thigh.

<span class="mw-page-title-main">Arven Pharmaceuticals</span>

Arven Pharmaceuticals is a Turkish pharmaceutical corporation headquartered in Istanbul established as a subsidiary of Toksöz Group in 2013. Arven's primary focus is development and production of high-technology inhaler and biotechnology products. The company is specialized on difficult to make products. Arven is the first Turkish company developing biosimilars for global markets, including the US and EU.

Spesolimab, sold under the brand name Spevigo, is a monoclonal antibody used for the treatment of generalized pustular psoriasis (GPP). It is an interleukin-36 receptor (IL-36R) antagonist. It is given via injection into a vein.

Efbemalenograstim alfa, sold under the brand name Ryzneuta, is a medication used to decrease the incidence of infection in chemotherapy-induced neutropenia. It is a leukocyte growth factor. It is given by subcutaneous injection.

References

  1. 1 2 "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. 1 2 3 "Releuko- filgrastim injection, solution". DailyMed. 11 March 2022. Archived from the original on 17 March 2022. Retrieved 16 March 2022.
  3. 1 2 3 https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761126s000lbl.pdf [ bare URL PDF ]
  4. 1 2 "Accofil EPAR". European Medicines Agency (EMA). 17 September 2018. Archived from the original on 23 March 2020. Retrieved 2 April 2020.
  5. 1 2 "Biograstim EPAR". European Medicines Agency (EMA). 17 September 2018. Archived from the original on 22 October 2020. Retrieved 2 April 2020.
  6. 1 2 "Grastofil EPAR". European Medicines Agency (EMA). 17 September 2018. Archived from the original on 12 November 2020. Retrieved 2 April 2020.
  7. 1 2 3 "Nivestim EPAR". European Medicines Agency (EMA). 17 September 2018. Archived from the original on 20 December 2019. Retrieved 20 December 2019.
  8. 1 2 "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. 1 2 "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. 1 2 "Ratiograstim EPAR". European Medicines Agency (EMA). 17 September 2018. Archived from the original on 14 August 2020. Retrieved 2 April 2020.
  11. 1 2 3 "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. 1 2 "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. 1 2 3 4 5 6 7 8 9 10 11 12 13 "Neupogen- filgrastim injection, solution". DailyMed. 15 November 2019. Archived from the original on 25 November 2020. Retrieved 20 December 2019.
  19. 1 2 3 4 5 6 7 8 9 10 11 "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. 1 2 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. ↑ 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)
  36. ↑ 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

This page is based on this Wikipedia article
Text is available under the CC BY-SA 4.0 license; additional terms may apply.
Images, videos and audio are available under their respective licenses.