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]
Clinical data | |
---|---|
Trade names | Elocta, Eloctate |
Other names | Antihemophilic Factor (Recombinant), FcFusion Protein |
License data | |
Routes of administration | Intravenous (IV) |
Drug class | Antihemorrhagic |
ATC code |
|
Legal status | |
Legal status | |
Identifiers | |
CAS Number | |
DrugBank | |
UNII | |
KEGG | |
Chemical and physical data | |
Formula | C9736H14863N2591O2855S78 |
Molar mass | 216390.96 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
- "Elocta 1000 IU powder and solvent for solution for injection - Summary of Product Characteristics (SmPC)". (emc). Retrieved 3 September 2020.
- "Eloctate (antihemophilic factor- recombinant, fc fusion protein kit". DailyMed. 4 August 2020. Retrieved 3 September 2020.
- "Elocta EPAR". European Medicines Agency (EMA). Retrieved 3 September 2020.
- "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.