Efmoroctocog alfa explained

Tradename:Elocta, Eloctate
Licence Eu:yes
Dailymedid:Eloctate
Pregnancy Au:C
Routes Of Administration:Intravenous
Class:Antihemorrhagic
Atc Prefix:None
Legal Au:Unscheduled
Legal Au Comment:[1] [2] [3]
Legal Uk:POM
Legal Uk Comment:[4]
Legal Us:Rx-only
Legal Us Comment:[5]
Legal Eu:Rx-only
Cas Number:1270012-79-7
Drugbank:DB11607
Unii:7PCM518YLR
Kegg:D10830
Kegg2:D10539
Synonyms:Antihemophilic Factor (Recombinant), FcFusion Protein
C:9736
H:14863
N:2591
O:2855
S:78

Efmoroctocog alfa, sold under the brand name Elocta among others, is a medication for the treatment and prophylaxis of bleeding in people with hemophilia A.[6] Efmoroctocog alfa is a recombinant human coagulation factor VIII, Fc fusion protein (rFVIIIFc). It is produced by recombinant DNA technology in a human embryonic kidney (HEK) cell line.

It was approved for medical use in the United States in June 2014,[7] and for use in the European Union in November 2015.

Medical uses

In the United States, efmoroctocog alfa (Eloctate) is indicated for adults and children with Hemophilia A for (1) on-demand treatment and control of bleeding episodes, (2) perioperative management, and (3) routine prophylaxis to prevent or reduce the frequency of bleeding episodes.[8]

In the European Union, efmoroctocog alfa (Elocta) is indicated for treatment and prophylaxis of bleeding in people with haemophilia A.[9]

Notes and References

  1. Web site: AusPAR: Efmoroctocog alfa (rhu) . Therapeutic Goods Administration (TGA) . 21 June 2022 . 28 April 2023 . 19 April 2023 . https://web.archive.org/web/20230419154749/https://www.tga.gov.au/resources/auspar/auspar-efmoroctocog-alfa-rhu . live .
  2. Web site: Prescription medicines: registration of new chemical entities in Australia, 2014 . Therapeutic Goods Administration (TGA) . 21 June 2022 . 10 April 2023 . 10 April 2023 . https://web.archive.org/web/20230410065838/https://www.tga.gov.au/resources/resource/guidance/prescription-medicines-registration-new-chemical-entities-australia-2014 . live .
  3. Web site: Archived copy . 11 April 2023 . 11 April 2023 . https://web.archive.org/web/20230411012654/https://www.tga.gov.au/sites/default/files/auspar-efraloctocog-alfa-150130-pi.pdf . live .
  4. Web site: Elocta 1000 IU powder and solvent for solution for injection - Summary of Product Characteristics (SmPC) . (emc) . 3 September 2020 . 28 October 2020 . https://web.archive.org/web/20201028152355/https://www.medicines.org.uk/emc/product/10484/smpc . live .
  5. Web site: Eloctate (antihemophilic factor- recombinant, fc fusion protein kit . DailyMed . 4 August 2020 . 3 September 2020 . 29 October 2020 . https://web.archive.org/web/20201029133426/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bec39fa0-1524-4e6b-897f-db0ef093085e . live .
  6. Frampton JE . Efmoroctocog Alfa: A Review in Haemophilia A . Drugs . 81 . 17 . 2035–2046 . November 2021 . 34743314 . 8636404 . 10.1007/s40265-021-01615-w .
  7. Web site: June 6, 2014 Approval Letter- Eloctate . U.S. Food and Drug Administration (FDA) . 6 June 2014 . https://wayback.archive-it.org/7993/20170723023602/https://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/ucm400189.htm . 23 July 2017 . dead . 3 September 2020 .
  8. Web site: Eloctate . U.S. Food and Drug Administration (FDA) . 22 July 2017 . 3 September 2020 . STN: BL 125487 . 29 November 2020 . https://web.archive.org/web/20201129053301/https://www.fda.gov/vaccines-blood-biologics/approved-blood-products/eloctate . live .
  9. Web site: Elocta EPAR . European Medicines Agency (EMA) . 10 December 2015 . 3 September 2020 . 5 August 2020 . https://web.archive.org/web/20200805172358/https://www.ema.europa.eu/en/medicines/human/EPAR/elocta . live .

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