Biology:Efmoroctocog alfa
| Clinical data | |
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| Trade names | Elocta, Eloctate |
| Other names | Antihemophilic Factor (Recombinant), FcFusion Protein |
| License data | |
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| Routes of administration | Intravenous |
| Drug class | Antihemorrhagic |
| ATC code |
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| Legal status | |
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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
- ↑ 1.0 1.1 "AusPAR: Efmoroctocog alfa (rhu)". 21 June 2022. https://www.tga.gov.au/resources/auspar/auspar-efmoroctocog-alfa-rhu.
- ↑ "Prescription medicines: registration of new chemical entities in Australia, 2014". 21 June 2022. https://www.tga.gov.au/resources/resource/guidance/prescription-medicines-registration-new-chemical-entities-australia-2014.
- ↑ "Archived copy". https://www.tga.gov.au/sites/default/files/auspar-efraloctocog-alfa-150130-pi.pdf.
- ↑ "Elocta 1000 IU powder and solvent for solution for injection - Summary of Product Characteristics (SmPC)". https://www.medicines.org.uk/emc/product/10484/smpc.
- ↑ 5.0 5.1 5.2 5.3 5.4 "Eloctate (antihemophilic factor- recombinant, fc fusion protein kit". 4 August 2020. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bec39fa0-1524-4e6b-897f-db0ef093085e.
- ↑ 6.0 6.1 6.2 6.3 6.4 "Elocta EPAR". https://www.ema.europa.eu/en/medicines/human/EPAR/elocta.
- ↑ "Efmoroctocog Alfa: A Review in Haemophilia A". Drugs 81 (17): 2035–2046. November 2021. doi:10.1007/s40265-021-01615-w. PMID 34743314.
- ↑ "June 6, 2014 Approval Letter- Eloctate". 6 June 2014. https://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/ucm400189.htm.
- ↑ "Eloctate". 22 July 2017. https://www.fda.gov/vaccines-blood-biologics/approved-blood-products/eloctate.
This article incorporates text from this source, which is in the public domain.
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