Efmoroctocog alfa
Clinical data
Trade namesElocta, Eloctate
Other namesAntihemophilic Factor (Recombinant), FcFusion Protein
License data
Pregnancy
category
Routes of
administration		Intravenous
Drug classAntihemorrhagic
ATC code
  • None
Legal status
Legal status
Identifiers
CAS Number
DrugBank
UNII
KEGG
Chemical and physical data
FormulaC9736H14863N2591O2855S78
Molar mass216390.96 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). 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. Public Domain This article incorporates text from this source, which is in the public domain.


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