Damoctocog alfa pegol explained

Tradename:Jivi
Dailymedid:Damoctocog alfa
Pregnancy Au:B2
Pregnancy Au Comment:[1]
Routes Of Administration:Intravenous
Atc Prefix:B02
Atc Suffix:BD02
Legal Au:S4
Legal Au Comment:[2] [3]
Legal Ca:Rx-only
Legal Ca Comment:/Schedule D[4]
Legal Us:Rx-only
Legal Us Comment:[5]
Legal Eu:Rx-only
Legal Eu Comment:[6]
Legal Status:Rx-only
Cas Number:1363853-26-2
Drugbank:DB14700
Unii:BY4TSK952Y
Kegg:D10759
Synonyms:BAY94-9027, antihemophilic factor (recombinant), pegylated-aucl
C:7445
H:11318
N:1984
O:2184
S:69

Damoctocog alfa pegol, sold under the brand name Jivi is a recombinant DNA-derived, Factor VIII concentrate used to treat hemophilia A.

The most common side effects include headache, cough, nausea, and fever.

Damoctocog alfa pegol was approved for medical use in the United States in August 2018,[7] and in the European Union in November 2018.[8] __TOC__

Medical uses

In the United States damoctocog alfa pegol is indicated for use in previously treated people twelve years of age and older with hemophilia A (congenital Factor VIII deficiency) for on-demand treatment and control of bleeding episodes; perioperative management of bleeding; or routine prophylaxis to reduce the frequency of bleeding episodes.

In the European Union, damoctocog alfa pegol is indicated for the treatment and prophylaxis of bleeding in previously treated people twelve years of age and older with hemophilia A (congenital factor VIII deficiency).

Notes and References

  1. Web site: Jivi . Therapeutic Goods Administration (TGA) . 6 April 2023 . 7 April 2023 . 8 April 2023 . https://web.archive.org/web/20230408034618/https://www.tga.gov.au/resources/auspmd/jivi . live .
  2. Web site: Jivi damoctocog alfa pegol 250 IU powder for injection vial with diluent syringe (384590) . Therapeutic Goods Administration (TGA) . 28 March 2023 . 7 April 2023 . 8 April 2023 . https://web.archive.org/web/20230408034618/https://www.tga.gov.au/resources/artg/384590 . live .
  3. https://www.tga.gov.au/resources/auspar/auspar-jivi
  4. Web site: Regulatory Decision Summary for Jivi . 23 October 2014 . 7 June 2022 . 7 June 2022 . https://web.archive.org/web/20220607074624/https://hpr-rps.hres.ca/reg-content/regulatory-decision-summary-detail.php?lang=en&linkID=RDS00474 . live .
  5. Web site: Jivi (antihemophilic factor- recombinant pegylated-aucl kit . DailyMed . 30 August 2018 . 1 October 2020 . 11 October 2020 . https://web.archive.org/web/20201011042751/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f04e5bd5-d7e2-453b-a407-2616d81a695d . live .
  6. Web site: Jivi EPAR . European Medicines Agency (EMA) . 24 September 2018 . 1 October 2020 . 2 October 2020 . https://web.archive.org/web/20201002031613/https://www.ema.europa.eu/en/medicines/human/EPAR/jivi . live . Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  7. Web site: Jivi . U.S. Food and Drug Administration (FDA) . 29 August 2018 . 1 October 2020 . STN: BL 125661 . 30 October 2020 . https://web.archive.org/web/20201030020504/https://www.fda.gov/vaccines-blood-biologics/jivi . live .
  8. Paik J, Deeks ED . Damoctocog Alfa Pegol: A Review in Haemophilia A . Drugs . 79 . 10 . 1147–1156 . July 2019 . 31218660 . 6711950 . 10.1007/s40265-019-01152-7 .

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