Efmoroctocog alfa

Efmoroctocog alfa
Clinical data
Trade names	Elocta, Eloctate
Other names	Antihemophilic Factor (Recombinant), FcFusion Protein
License data	EU EMA: by INN; US DailyMed: Eloctate;
Routes of; administration	Intravenous (IV)
Drug class	Antihemorrhagic
ATC code	None;
Legal status
Legal status	AU: Unscheduled ; UK: POM (Prescription only) ; US: ℞-only ; EU: Rx-only ;
Identifiers
CAS Number	1270012-79-7;
DrugBank	DB11607;
UNII	7PCM518YLR;
KEGG	D10830; D10539;
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.^[2]^[3]^[4] 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]

It was approved for medical use in the United States in June 2014,^[5] 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.^[6]^[2]

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

References[]

^ "Elocta 1000 IU powder and solvent for solution for injection - Summary of Product Characteristics (SmPC)". (emc). Retrieved 3 September 2020.
^ ^a ^b ^c ^d ^e "Eloctate (antihemophilic factor- recombinant, fc fusion protein kit". DailyMed. 4 August 2020. Retrieved 3 September 2020.
^ ^a ^b ^c ^d ^e "Elocta EPAR". European Medicines Agency (EMA). Retrieved 3 September 2020.
^ 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.
^ "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.
^ "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.

External links[]

"Efmoroctocog alfa". Drug Information Portal. U.S. National Library of Medicine.

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[1] "Elocta 1000 IU powder and solvent for solution for injection - Summary of Product Characteristics (SmPC)". (emc). Retrieved 3 September 2020.

[FDA_Eloctate_label-2] "Eloctate (antihemophilic factor- recombinant, fc fusion protein kit". DailyMed. 4 August 2020. Retrieved 3 September 2020.

[Elocta_EPAR-3] "Elocta EPAR". European Medicines Agency (EMA). Retrieved 3 September 2020.

[Frampton_2021-4] 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.

[5] "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.

[6] "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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