Efmoroctocog alfa

Last updated

Efmoroctocog alfa
Clinical data
Trade names Elocta, Eloctate
Other namesAntihemophilic Factor (Recombinant), FcFusion Protein
License data
Pregnancy
category
Routes of
administration 		Intravenous
Drug class Antihemorrhagic
ATC code
  • None
Legal status
Legal status
Identifiers
CAS Number
DrugBank
UNII
KEGG
Chemical and physical data
Formula C9736H14863N2591O2855S78
Molar mass 216390.96 g·mol−1

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. [5] [6] [7] Efmoroctocog alfa is a recombinant human coagulation factor VIII, Fc fusion protein (rFVIIIFc). [5] It is produced by recombinant DNA technology in a human embryonic kidney (HEK) cell line. [5] [6]

It was approved for medical use in the United States in June 2014, [8] and for use in the European Union in November 2015. [6]

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. [9] [5]

In the European Union, efmoroctocog alfa (Elocta) is indicated for treatment and prophylaxis of bleeding in people with haemophilia A. [6]

References

  1. 1 2 "AusPAR: Efmoroctocog alfa (rhu)". Therapeutic Goods Administration (TGA). 21 June 2022. Archived from the original on 19 April 2023. Retrieved 28 April 2023.
  2. ↑ "Prescription medicines: registration of new chemical entities in Australia, 2014". Therapeutic Goods Administration (TGA). 21 June 2022. Archived from the original on 10 April 2023. Retrieved 10 April 2023.
  3. ↑ "Archived copy" (PDF). Archived (PDF) from the original on 11 April 2023. Retrieved 11 April 2023.{{cite web}}: CS1 maint: archived copy as title (link)
  4. ↑ "Elocta 1000 IU powder and solvent for solution for injection - Summary of Product Characteristics (SmPC)". (emc). Archived from the original on 28 October 2020. Retrieved 3 September 2020.
  5. 1 2 3 4 5 "Eloctate (antihemophilic factor- recombinant, fc fusion protein kit". DailyMed. 4 August 2020. Archived from the original on 29 October 2020. Retrieved 3 September 2020.
  6. 1 2 3 4 5 "Elocta EPAR". European Medicines Agency (EMA). 10 December 2015. Archived from the original on 5 August 2020. Retrieved 3 September 2020.
  7. ↑ Frampton JE (November 2021). "Efmoroctocog Alfa: A Review in Haemophilia A". Drugs. 81 (17): 2035–2046. doi:10.1007/s40265-021-01615-w. PMC   8636404 . PMID   34743314.
  8. ↑ "June 6, 2014 Approval Letter- Eloctate". U.S. Food and Drug Administration (FDA). 6 June 2014. Archived from the original on 23 July 2017. Retrieved 3 September 2020.
  9. ↑ "Eloctate". U.S. Food and Drug Administration (FDA). 22 July 2017. STN: BL 125487. Archived from the original on 29 November 2020. Retrieved 3 September 2020.PD-icon.svg This article incorporates text from this source, which is in the public domain .
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.