Array ( [0] => {{Short description|Medication}} [1] => {{distinguish|granulocyte-macrophage colony-stimulating factor|epoetin alfa}} [2] => {{Use dmy dates|date=February 2022}} [3] => {{cs1 config |name-list-style=vanc |display-authors=6}} [4] => {{drugbox [5] => | image = filgrastim.jpg [6] => | width = 184 [7] => | alt = [8] => | caption = [9] => | type = [10] => [11] => [12] => | pronounce = [13] => | tradename = Neupogen, others [14] => | Drugs.com = {{drugs.com|monograph|filgrastim}} [15] => | MedlinePlus = a692033 [16] => | DailyMedID = Filgrastim [17] => | pregnancy_AU = B3 [18] => | pregnancy_AU_comment = {{cite web | title=Filgrastim Use During Pregnancy | website=Drugs.com | date=13 September 2018 | url=https://www.drugs.com/pregnancy/filgrastim.html | access-date=17 December 2019 | archive-date=18 December 2019 | archive-url=https://web.archive.org/web/20191218054847/https://www.drugs.com/pregnancy/filgrastim.html | url-status=live }} [19] => | pregnancy_category = [20] => | routes_of_administration = [[Intraveneous]], [[Subcutaneous injection|subcutaneous]] [21] => | class = Hematopoietic agents, [[colony-stimulating factor]]s [22] => | ATC_prefix = L03 [23] => | ATC_suffix = AA02 [24] => | ATC_supplemental = [25] => | biosimilars = filgrastim-aafi, filgrastim-sndz, filgrastim-ayow, Accofil, Biograstim, Fraven Grastofil, Nivestim, Nivestym, Nypozi, Ratiograstim, Releuko,{{cite web | title=Releuko- filgrastim injection, solution | website=DailyMed | date=11 March 2022 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=74e1ec6e-1630-4654-895c-2bd355f939e7 | access-date=16 March 2022 | archive-date=17 March 2022 | archive-url=https://web.archive.org/web/20220317050614/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=74e1ec6e-1630-4654-895c-2bd355f939e7 | url-status=live }} Tevagrastim, Zarxio, Zarzio [26] => [27] => [28] => | legal_AU = [29] => | legal_AU_comment = [30] => | legal_BR = [31] => | legal_BR_comment = [32] => | legal_CA = Rx-only [33] => | legal_CA_comment = / Schedule D{{cite web | title=Health product highlights 2021: Annexes of products approved in 2021 | website=[[Health Canada]] | date=3 August 2022 | url=https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/health-product-highlights-2021/appendices.html | access-date=25 March 2024}} [34] => | legal_DE = [35] => | legal_DE_comment = [36] => | legal_NZ = [37] => | legal_NZ_comment = [38] => | legal_UK = POM [39] => | legal_UK_comment = {{cite web | title=Neupogen 30 MU (0.3 mg/ml) solution for injection - Summary of Product Characteristics (SmPC) | website=(emc) | date=7 May 2021 | url=https://www.medicines.org.uk/emc/product/3000/smpc | access-date=1 March 2022 | archive-date=1 March 2022 | archive-url=https://web.archive.org/web/20220301025307/https://www.medicines.org.uk/emc/product/3000/smpc | url-status=live }}{{cite web | title=Zarzio 30 MU/0.5 ml solution for injection or infusion in pre-filled syringe - Summary of Product Characteristics (SmPC) | website=(emc) | date=4 July 2019 | url=https://www.medicines.org.uk/emc/product/6672/smpc | access-date=20 December 2019 | archive-date=20 December 2019 | archive-url=https://web.archive.org/web/20191220191620/https://www.medicines.org.uk/emc/product/6672/smpc | url-status=live }}{{cite web | title=Nivestim 12 MU/ 0.2 ml solution for injection/infusion - Summary of Product Characteristics (SmPC) | website=(emc) | date=18 December 2019 | url=https://www.medicines.org.uk/emc/product/575/smpc | access-date=20 December 2019 | archive-date=20 December 2019 | archive-url=https://web.archive.org/web/20191220191621/https://www.medicines.org.uk/emc/product/575/smpc | url-status=live }} [40] => | legal_US = Rx-only [41] => | legal_US_comment = [42] => | legal_EU = Rx-only [43] => | legal_EU_comment = [44] => | legal_UN = [45] => | legal_UN_comment = [46] => | legal_status = [47] => [48] => [49] => | bioavailability = [50] => | protein_bound = [51] => | metabolism = [52] => | metabolites = [53] => | onset = [54] => | elimination_half-life = [55] => | duration_of_action = [56] => | excretion = [57] => [58] => [59] => | CAS_number = 121181-53-1 [60] => | CAS_supplemental = [61] => | PubChem = [62] => | IUPHAR_ligand = 6968 [63] => | DrugBank = DB00099 [64] => | ChemSpiderID = none [65] => | UNII_Ref = {{fdacite|correct|FDA}} [66] => | UNII = PVI5M0M1GW [67] => | KEGG = D03235 [68] => | ChEBI = [69] => | ChEMBL = 1201567 [70] => | NIAID_ChemDB = [71] => | PDB_ligand = [72] => | synonyms = XM02 [73] => [74] => [75] => | IUPAC_name = Human granulocyte colony stimulating factor [76] => | C = 845 [77] => | H = 1343 [78] => | N = 223 [79] => | O = 243 [80] => | S = 9 [81] => | SMILES = [82] => | StdInChI = [83] => | StdInChI_comment = [84] => | StdInChIKey = [85] => | density = [86] => | density_notes = [87] => | melting_point = [88] => | melting_high = [89] => | melting_notes = [90] => | boiling_point = [91] => | boiling_notes = [92] => | solubility = [93] => | sol_units = [94] => | specific_rotation = [95] => }} [96] => [97] => [98] => '''Filgrastim''', sold under the brand name '''Neupogen''' among others, is a [[medication]] used to treat [[neutropenia|low neutrophil count]]. Low neutrophil counts may occur with [[HIV/AIDS]], following [[chemotherapy]] or [[radiation poisoning]], or be of an unknown cause. It may also be used to increase white blood cells for gathering during [[leukapheresis]]. It is given either by [[intravenous|injection into a vein]] or [[Subcutaneous injection|under the skin]]. Filgrastim is a leukocyte growth factor. [99] => [100] => [101] => Common side effects include fever, cough, chest pain, joint pain, vomiting, and hair loss. Severe side effects include [[splenic rupture]] and [[allergic reactions]]. It is unclear if use in [[pregnancy]] is safe for the baby. Filgrastim is a recombinant form of the naturally occurring [[granulocyte colony-stimulating factor]] (G-CSF). It works by stimulating the body to increase [[neutrophil]] production. [102] => [103] => [104] => Filgrastim was approved for medical use in the United States in 1991.{{cite web|title=Filgrastim|url=https://www.drugs.com/monograph/filgrastim.html |publisher=The American Society of Health-System Pharmacists|access-date=8 December 2016|url-status=live|archive-url=https://web.archive.org/web/20170510112413/https://www.drugs.com/monograph/filgrastim.html |archive-date=10 May 2017}} It is on the [[WHO Model List of Essential Medicines|World Health Organization's List of Essential Medicines]].{{cite book | vauthors = ((World Health Organization)) | title = World Health Organization model list of essential medicines: 21st list 2019 | year = 2019 | hdl = 10665/325771 | author-link = World Health Organization | publisher = World Health Organization | location = Geneva | id = WHO/MVP/EMP/IAU/2019.06. License: CC BY-NC-SA 3.0 IGO | hdl-access=free }}{{cite book | vauthors = ((World Health Organization)) | title = World Health Organization model list of essential medicines: 22nd list (2021) | year = 2021 | hdl = 10665/345533 | author-link = World Health Organization | publisher = World Health Organization | location = Geneva | id = WHO/MHP/HPS/EML/2021.02 | hdl-access=free }} Filgrastim [[biosimilar]] medications are available. [105] => [106] => ==Medical uses== [107] => Filgrastim is used to treat neutropenia; acute myeloid leukemia; nonmyeloid malignancies; leukapheresis; congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia; and myelosuppressive doses of radiation.{{cite web | title=FDA Approves Radiation Medical Countermeasure | website=U.S. Food and Drug Administration | date=30 March 2015 | url=https://www.fda.gov/emergency-preparedness-and-response/about-mcmi/fda-approves-radiation-medical-countermeasure | access-date=8 September 2023}} [108] => [109] => 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.{{cite web | title=Granix- tbo-filgrastim injection, solution | website=DailyMed | date=30 November 2019 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=df918ec2-0907-443f-a52a-b72866959644 | access-date=8 September 2023}} [110] => [111] => ==Adverse effects== [112] => The most commonly observed adverse effect is mild bone pain after repeated administration,{{cite journal | vauthors = Moore DC, Pellegrino AE | title = Pegfilgrastim-Induced Bone Pain: A Review on Incidence, Risk Factors, and Evidence-Based Management | journal = The Annals of Pharmacotherapy | volume = 51 | issue = 9 | pages = 797–803 | date = September 2017 | pmid = 28423916 | doi = 10.1177/1060028017706373 | s2cid = 33032446 }} and local skin reactions at the site of injection.{{cite web | title=Neupogen- filgrastim injection, solution | website=DailyMed | date=15 November 2019 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=97cc73cc-b5b7-458a-a933-77b00523e193 | access-date=20 December 2019 | archive-date=25 November 2020 | archive-url=https://web.archive.org/web/20201125222325/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=97cc73cc-b5b7-458a-a933-77b00523e193 | url-status=live }} Other observed adverse effects include serious allergic reactions (including a rash over the whole body,{{cite journal | vauthors = Scott WR, Silberstein L, Flatley R, Ardeshna KM, Korostoff N, Dawe S | title = Cutaneous reaction to pegfilgrastim presenting as severe generalized skin eruption | journal = The British Journal of Dermatology | volume = 161 | issue = 3 | pages = 717–719 | date = September 2009 | pmid = 19614649 | doi = 10.1111/j.1365-2133.2009.09371.x | s2cid = 2655192 }} shortness of breath, wheezing, dizziness, swelling around the mouth or eyes, fast pulse, and sweating), [[ruptured spleen]] (sometimes resulting in death),{{cite journal | vauthors = Zimmer BM, Berdel WE, Ludwig WD, Notter M, Reufi B, Thiel E | title = Fatal spleen rupture during induction chemotherapy with rh GM-CSF priming for acute monocytic leukemia. Clinical case report and in vitro studies | journal = Leukemia Research | volume = 17 | issue = 3 | pages = 277–283 | date = March 1993 | pmid = 8450676 | doi = 10.1016/0145-2126(93)90012-a }} [[Pulmonary alveolus|alveolar]] [[Bleeding|hemorrhage]], [[acute respiratory distress syndrome]], and [[hemoptysis]]. Severe [[Sickle cell crisis|sickle cell crises]], in some cases resulting in death, have been associated with the use of filgrastim in people with sickle cell disorders. [113] => [114] => == Interactions == [115] => 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. [116] => [117] => ==Mechanism of action== [118] => 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). [119] => [120] => ==Society and culture== [121] => [122] => ===Biosimilars=== [123] => {{see also|Biosimilars}} [124] => [125] => In 2015, Sandoz's filgrastim-sndz (trade name Zarxio), obtained the approval of the U.S. [[Food and Drug Administration]] (FDA) as a biosimilar.{{cite press release |date=6 March 2015 |access-date=23 November 2015 |url=https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm436648.htm |title=FDA approves first biosimilar product Zarxio |work=U.S. [[Food and Drug Administration]] (FDA) |url-status=dead |archive-url=https://web.archive.org/web/20151211053044/https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm436648.htm |archive-date=11 December 2015 }}{{cite web | title=Zarxio (filgrastim-sndz) | website=U.S. [[Food and Drug Administration]] (FDA) | date=20 April 2015 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125553Orig1s000TOC.cfm | archive-url=https://web.archive.org/web/20191220184811/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125553Orig1s000TOC.cfm | archive-date=20 December 2019 | url-status=live | access-date=20 December 2019}}{{cite news | vauthors = Tavernise S, Pollack A |title=F.D.A. Approves Zarxio, Its First Biosimilar Drug |url=https://www.nytimes.com/2015/03/07/health/fda-approves-zarxio-first-biosimilar-drug.html |newspaper=[[The New York Times]] |date=6 March 2015 |access-date=23 November 2015 |url-status=live |archive-url=https://web.archive.org/web/20151023143537/http://www.nytimes.com/2015/03/07/health/fda-approves-zarxio-first-biosimilar-drug.html |archive-date=23 October 2015 }} 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]]. 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. [126] => [127] => In 2018, filgrastim-aafi (trade name Nivestym) was approved for use in the United States.{{cite web | title=Drug Approval Package: Nivestym (filgrastim-aafi) | website=U.S. [[Food and Drug Administration]] (FDA) | date=21 February 2019 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761080Orig1s000TOC.cfm | archive-url=https://web.archive.org/web/20191220184614/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761080Orig1s000TOC.cfm | archive-date=20 December 2019 | url-status=live | access-date=20 December 2019}} [128] => [129] => In September 2008, Ratiograstim, Tevagrastim, Biograstim, and Filgrastim ratiopharm were approved for use in the European Union.{{cite web | title=Ratiograstim EPAR | website=[[European Medicines Agency]] (EMA) | date=17 September 2018 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/ratiograstim | access-date=2 April 2020 | archive-date=14 August 2020 | archive-url=https://web.archive.org/web/20200814211722/https://www.ema.europa.eu/en/medicines/human/EPAR/ratiograstim | url-status=live }}{{cite web | title=Tevagrastim EPAR | website=[[European Medicines Agency]] (EMA) | date=17 September 2018 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/tevagrastim | access-date=2 April 2020 | archive-date=16 October 2019 | archive-url=https://web.archive.org/web/20191016120016/https://www.ema.europa.eu/en/medicines/human/EPAR/tevagrastim | url-status=live }}{{cite web | title=Biograstim EPAR | website=[[European Medicines Agency]] (EMA) | date=17 September 2018 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/Biograstim | access-date=2 April 2020 | archive-date=22 October 2020 | archive-url=https://web.archive.org/web/20201022204309/https://www.ema.europa.eu/en/medicines/human/EPAR/biograstim | url-status=live }}{{cite web | title=Filgrastim ratiopharm EPAR | website=[[European Medicines Agency]] (EMA) | date=17 September 2018 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/filgrastim-ratiopharm | access-date=2 April 2020 | archive-date=21 January 2021 | archive-url=https://web.archive.org/web/20210121002356/https://www.ema.europa.eu/en/medicines/human/EPAR/filgrastim-ratiopharm | url-status=live }} Filgrastim ratiopharm was withdrawn in July 2011 and Biograstim was withdrawn in December 2016. [130] => [131] => In February 2009, Filgrastim Hexal and Zarzio were approved for use in the European Union.{{cite web | title=Filgrastim Hexal EPAR | website=[[European Medicines Agency]] (EMA) | date=17 September 2018 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/filgrastim-hexal | access-date=2 April 2020 | archive-date=30 December 2019 | archive-url=https://web.archive.org/web/20191230161956/https://www.ema.europa.eu/en/medicines/human/EPAR/filgrastim-hexal | url-status=live }}{{cite web | title=Zarzio EPAR | website=[[European Medicines Agency]] (EMA) | date=17 September 2018 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/zarzio | access-date=20 December 2019 | archive-date=15 October 2019 | archive-url=https://web.archive.org/web/20191015190413/https://www.ema.europa.eu/en/medicines/human/EPAR/zarzio | url-status=live }} [132] => [133] => In June 2010, Nivestim was approved for use in the European Union.{{cite web | title=Nivestim EPAR | website=[[European Medicines Agency]] (EMA) | date=17 September 2018 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/nivestim | access-date=20 December 2019 | archive-date=20 December 2019 | archive-url=https://web.archive.org/web/20191220191624/https://www.ema.europa.eu/en/medicines/human/EPAR/nivestim | url-status=live }} [134] => [135] => In October 2013, Grastofil was approved for use in the European Union.{{cite web | title=Grastofil EPAR | website=[[European Medicines Agency]] (EMA) | date=17 September 2018 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/grastofil | access-date=2 April 2020 | archive-date=12 November 2020 | archive-url=https://web.archive.org/web/20201112002249/https://www.ema.europa.eu/en/medicines/human/EPAR/grastofil | url-status=live }} [136] => [137] => In September 2014, Accofil was approved for use in the European Union.{{cite web | title=Accofil EPAR | website=[[European Medicines Agency]] (EMA) | date=17 September 2018 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/accofil | access-date=2 April 2020 | archive-date=23 March 2020 | archive-url=https://web.archive.org/web/20200323235656/https://www.ema.europa.eu/en/medicines/human/EPAR/accofil | url-status=live }} [138] => [139] => In 2016, Fraven was approved for use by Republic of Turkey ministry of health.{{cite web | url = http://finans.gazetevatan.com/haber-detay/gundem/arven-ilac--turkiyenin-ilk-biyobenzer-urununu-uretti/48936/%7Ctitle=Arven%20ila%C3%A7 | archive-url = https://web.archive.org/web/20230211063004/https://finans.gazetevatan.com/haber-detay/gundem/arven-ilac--turkiyenin-ilk-biyobenzer-urununu-uretti/48936/%7Ctitle=Arven%20ila%C3%A7 | archive-date=11 February 2023 | title = Arven ilaç, Türkiyenin ilk biyobenzer ürününü üretti | trans-title = Arven Pharmaceuticals produced Turkey's first biosimilar product | language = Turkish | work = Vatan Finans }} [140] => [141] => Nivestym was approved for medical use in Canada in April 2020.{{cite web | title=Summary Basis of Decision (SBD) for Nivestym | website=Health Canada | date=23 October 2014 | url=https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00486&lang=en | access-date=29 May 2022 | archive-date=30 May 2022 | archive-url=https://web.archive.org/web/20220530213145/https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00486&lang=en | url-status=live }} [142] => [143] => In October 2021, Nypozi was approved for medical use in Canada.{{cite web | title=Summary Basis of Decision (SBD) for Nypozi | website=Health Canada | date=23 October 2014 | url=https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00569&lang=en | access-date=29 May 2022 | archive-date=25 September 2022 | archive-url=https://web.archive.org/web/20220925201028/https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00569&lang=en | url-status=live }} [144] => [145] => ===Economics=== [146] => 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.{{Cite book| vauthors = Neymark N |title=Assessing the Economic Value of Anticancer Therapies |journal=Recent Results in Cancer Research. Fortschritte der Krebsforschung. Progres dans les Recherches Sur le Cancer |series=Recent Results in Cancer Research|date=1998|volume=148|publisher=Springer |isbn=978-3-642-72123-6|location=Berlin, Heidelberg|pages=215–219|doi=10.1007/978-3-642-72123-6|pmid=9670279|s2cid=34894897|oclc=851760173}} The longer-acting [[pegfilgrastim]] may in some cases be more cost-effective.{{Cite book| vauthors = Ellery T |title=Pharmaceutical lifecycle management : making the most of each and every brand|date=2012|publisher=John Wiley & Sons|others=Hansen, Neal.|isbn=978-1-118-26679-3|location=Hoboken, N.J.|pages=214|oclc=797824835}} [147] => [148] => == References == [149] => {{Reflist}} [150] => [151] => == Further reading == [152] => * {{cite journal |vauthors=Blair HA, Scott LJ |title=Tbo-Filgrastim: A Review in Neutropenic Conditions |journal=BioDrugs |volume=30 |issue=2 |pages=153–60 |date=April 2016 |pmid=27023705 |doi=10.1007/s40259-016-0172-7 |s2cid=256368326 }} [153] => * {{cite book | veditors = Santoso B, van Boxtel CJ, Edwards RI |title=Drug benefits and risks: international textbook of clinical pharmacology |publisher=Wiley |location=New York |year=2001 |isbn=0-471-89927-5 }} [154] => [155] => {{Immunostimulants}} [156] => {{Cytokine receptor modulators}} [157] => {{Growth factor receptor modulators}} [158] => {{Portal bar|Medicine}} [159] => {{Authority control}} [160] => [161] => [[Category:Amgen]] [162] => [[Category:Drugs developed by Hoffmann-La Roche]] [163] => [[Category:Drugs developed by Novartis]] [164] => [[Category:Drugs developed by AbbVie]] [165] => [[Category:Drugs developed by Pfizer]] [166] => [[Category:Drugs acting on the blood and blood forming organs]] [167] => [[Category:Growth factors]] [168] => [[Category:Immunostimulants]] [169] => [[Category:Recombinant proteins]] [170] => [[Category:World Health Organization essential medicines]] [171] => [[Category:Wikipedia medicine articles ready to translate]] [] => )
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Filgrastim

Filgrastim, sold under the brand name Neupogen among others, is a medication used to treat low neutrophil count. Low neutrophil counts may occur with HIV/AIDS, following chemotherapy or radiation poisoning, or be of an unknown cause.

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