Susoctocog alfa explained
Tradename: | Obizur |
Dailymedid: | Obizur |
Pregnancy Au: | B2 |
Pregnancy Au Comment: | [1] |
Class: | Antihemophilic factor |
Atc Prefix: | B02 |
Atc Suffix: | BD14 |
Legal Au: | S4 |
Legal Au Comment: | [2] |
Legal Ca: | Rx-only |
Legal Ca Comment: | [3] |
Legal Uk: | POM |
Legal Uk Comment: | [4] |
Legal Us: | Rx-only |
Legal Eu: | Rx-only |
Legal Status: | Rx-only |
Cas Number: | 1339940-90-7 |
Drugbank: | DB11606 |
Unii: | 6892UQT2GK |
Kegg: | D10831 |
Synonyms: | Antihemophilic factor (recombinant) |
Susoctocog alfa, sold under the brand name Obizur, is a medication used for the treatment of bleeding episodes in adults with acquired haemophilia, a bleeding disorder caused by the spontaneous development of antibodies that inactivate factor VIII.[5] [6] [7]
Susoctocog alfa was approved for medical use in the United States in October 2014,[8] [9] and for medical use in the European Union in November 2015.
Factor VIII is one of the proteins needed for normal clotting of the blood.
Notes and References
- Web site: Antihemophilic factor Use During Pregnancy . Drugs.com . 20 January 2020 . 6 March 2020 . 16 July 2020 . https://web.archive.org/web/20200716175058/https://www.drugs.com/pregnancy/antihemophilic-factor.html . live .
- Web site: Prescription medicines: registration of new chemical entities in Australia, 2016 . Therapeutic Goods Administration (TGA) . 21 June 2022 . 10 April 2023 . 10 April 2023 . https://web.archive.org/web/20230410065503/https://www.tga.gov.au/prescription-medicines-registration-new-chemical-entities-australia-2016 . live .
- Web site: Health Canada New Drug Authorizations: 2015 Highlights . . 4 May 2016 . 7 April 2024 . 20 February 2020 . https://web.archive.org/web/20200220215421/https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/health-canada-new-drug-authorizations-2015-highlights.html . live .
- Web site: Obizur 500 U powder and solvent for solution for injection - Summary of Product Characteristics (SmPC) . (emc) . 13 April 2017 . 3 September 2020.
- Web site: Obizur EPAR . European Medicines Agency . 6 March 2020 . 6 March 2020 . 11 August 2020 . https://web.archive.org/web/20200811232311/https://www.ema.europa.eu/en/medicines/human/EPAR/obizur . live .
- Web site: Obizur (antihemophilic factor- recombinant, porcine sequence kit . DailyMed . 2 January 2020 . 6 March 2020 . 24 July 2021 . https://web.archive.org/web/20210724214358/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a69ccbb3-7648-4978-8c6d-7ca6b95a9b01 . live .
- Burness CB, Scott LJ . Susoctocog Alfa: A Review in Acquired Haemophilia A . Drugs . 76 . 7 . 815–21 . May 2016 . 27098420 . 10.1007/s40265-016-0576-1 . 10880049 .
- Web site: Obizur . U.S. Food and Drug Administration (FDA) . 13 March 2018 . 23 April 2019 . https://wayback.archive-it.org/7993/20190423063533/https://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/ucm419994.htm . 6 March 2020.
- Web site: Obizur . U.S. Food and Drug Administration (FDA) . 27 September 2019 . STN: BL 125512 . 6 March 2020 . 17 December 2019 . https://web.archive.org/web/20191217005216/https://www.fda.gov/vaccines-blood-biologics/approved-blood-products/obizur . live .