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

  1. 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 .
  2. 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 .
  3. 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 .
  4. Web site: Obizur 500 U powder and solvent for solution for injection - Summary of Product Characteristics (SmPC) . (emc) . 13 April 2017 . 3 September 2020.
  5. 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 .
  6. 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 .
  7. 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 .
  8. 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.
  9. 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 .