Efmoroctocog alfa

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.[2][3] Efmoroctocog alfa is a recombinant human coagulation factor VIII, Fc fusion protein (rFVIIIFc).[2] It is produced by recombinant DNA technology in a human embryonic kidney (HEK) cell line.[2][3]

Efmoroctocog alfa
Clinical data
Trade namesElocta, Eloctate
Other namesAntihemophilic Factor (Recombinant), FcFusion Protein
License data
Routes of
administration
Intravenous (IV)
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

It was approved for medical use in the United States in June 2014,[4] and for use in the European Union in November 2015.[3]

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.[5][2]

In the European Union, efmoroctocog alfa (Elocta) is indicated for treatment and prophylaxis of bleeding in people with haemophilia A.[3]

References

  1. "Elocta 1000 IU powder and solvent for solution for injection - Summary of Product Characteristics (SmPC)". (emc). Retrieved 3 September 2020.
  2. "Eloctate (antihemophilic factor- recombinant, fc fusion protein kit". DailyMed. 4 August 2020. Retrieved 3 September 2020.
  3. "Elocta EPAR". European Medicines Agency (EMA). Retrieved 3 September 2020.
  4. "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.
  5. "Eloctate". U.S. Food and Drug Administration (FDA). 22 July 2017. STN: BL 125487. Retrieved 3 September 2020. This article incorporates text from this source, which is in the public domain.


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