Efmoroctocog alfa
| Clinical data | |
|---|---|
| Trade names | Elocta, Eloctate |
| Other names | Antihemophilic Factor (Recombinant), FcFusion Protein |
| License data | |
| Pregnancy category |
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| Routes of administration | Intravenous |
| Drug class | Antihemorrhagic |
| ATC code |
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| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| UNII | |
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| 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
- ^ a b "AusPAR: Efmoroctocog alfa (rhu)". Therapeutic Goods Administration (TGA). 21 June 2022. Archived from the original on 19 April 2023. Retrieved 28 April 2023.
- ^ "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.
- ^ "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) - ^ "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.
- ^ a b c d e "Eloctate (antihemophilic factor- recombinant, fc fusion protein kit". DailyMed. 4 August 2020. Archived from the original on 29 October 2020. Retrieved 3 September 2020.
- ^ a b c d e "Elocta EPAR". European Medicines Agency (EMA). Archived from the original on 5 August 2020. Retrieved 3 September 2020.
- 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. Archived from the original on 29 November 2020. Retrieved 3 September 2020.
This article incorporates text from this source, which is in the public domain.
