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The most common side effects include headache, cough, nausea and fever.<ref name="Jivi FDA label" />
The most common side effects include headache, cough, nausea and fever.<ref name="Jivi FDA label" />


Damoctocog alfa pegol ([[antihemophilic factor- recombinant pegylated-aucl) was approved for medical use in the United States in August 2018,<ref name="Jivi FDA">{{cite web | title=Jivi | website=U.S. [[Food and Drug Administration]] (FDA) | date=29 August 2018 | url=https://www.fda.gov/vaccines-blood-biologics/jivi | access-date=1 October 2020 | id=STN: BL 125661 }} {{PD-notice}}</ref> and in the European Union in November 2018.<ref name="Jivi EPAR" /><ref name="Paik_2019">{{cite journal | vauthors = Paik J, Deeks ED | title = Damoctocog Alfa Pegol: A Review in Haemophilia A | journal = Drugs | volume = 79 | issue = 10 | pages = 1147–1156 | date = July 2019 | pmid = 31218660 | pmc = 6711950 | doi = 10.1007/s40265-019-01152-7 }}</ref>
Damoctocog alfa pegol (antihemophilic factor- recombinant pegylated-aucl) was approved for medical use in the United States in August 2018,<ref name="Jivi FDA">{{cite web | title=Jivi | website=U.S. [[Food and Drug Administration]] (FDA) | date=29 August 2018 | url=https://www.fda.gov/vaccines-blood-biologics/jivi | access-date=1 October 2020 | id=STN: BL 125661 }} {{PD-notice}}</ref> and in the European Union in November 2018.<ref name="Jivi EPAR" /><ref name="Paik_2019">{{cite journal | vauthors = Paik J, Deeks ED | title = Damoctocog Alfa Pegol: A Review in Haemophilia A | journal = Drugs | volume = 79 | issue = 10 | pages = 1147–1156 | date = July 2019 | pmid = 31218660 | pmc = 6711950 | doi = 10.1007/s40265-019-01152-7 }}</ref>
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== Medical uses ==
== Medical uses ==

Revision as of 04:01, 15 November 2023

Damoctocog alfa pegol
Clinical data
Trade namesJivi
Other namesBAY94-9027, antihemophilic factor (recombinant), PEGylated-aucl
AHFS/Drugs.comMonograph
License data
Pregnancy
category
Routes of
administration		Intravenous
ATC code
Legal status
Legal status
Identifiers
CAS Number
DrugBank
UNII
KEGG
Chemical and physical data
FormulaC7445H11318N1984O2184S69
Molar mass165774.28 g·mol−1

Damoctocog alfa pegol, sold under the brand name Jivi is a recombinant DNA-derived, Factor VIII concentrate medication used to treat hemophilia A.[4][5]

The most common side effects include headache, cough, nausea and fever.[4]

Damoctocog alfa pegol (antihemophilic factor- recombinant pegylated-aucl) was approved for medical use in the United States in August 2018,[6] and in the European Union in November 2018.[5][7]

Medical uses

In the United States damoctocog alfa pegol is indicated for use in previously treated adults and adolescents (twelve years of age and older) with hemophilia A (congenital Factor VIII deficiency) for: (1) On-demand treatment and control of bleeding episodes ; (2) Perioperative management of bleeding; (3) Routine prophylaxis to reduce the frequency of bleeding episodes.[6]

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 haemophilia A (congenital factor VIII deficiency).[5]

References

  1. ^ a b "Jivi". Therapeutic Goods Administration (TGA). 6 April 2023. Retrieved 7 April 2023.
  2. ^ "Jivi damoctocog alfa pegol 250 IU powder for injection vial with diluent syringe (384590)". Therapeutic Goods Administration (TGA). 28 March 2023. Retrieved 7 April 2023.
  3. ^ "Search Page - Drug and Health Product Register". 23 October 2014.
  4. ^ a b c "Jivi (antihemophilic factor- recombinant pegylated-aucl kit". DailyMed. 30 August 2018. Retrieved 1 October 2020.
  5. ^ a b c d "Jivi EPAR". European Medicines Agency (EMA). 24 September 2018. Retrieved 1 October 2020. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  6. ^ a b "Jivi". U.S. Food and Drug Administration (FDA). 29 August 2018. STN: BL 125661. Retrieved 1 October 2020. Public Domain This article incorporates text from this source, which is in the public domain.
  7. ^ Paik J, Deeks ED (July 2019). "Damoctocog Alfa Pegol: A Review in Haemophilia A". Drugs. 79 (10): 1147–1156. doi:10.1007/s40265-019-01152-7. PMC 6711950. PMID 31218660.
  • "Damoctocog alfa pegol". Drug Information Portal. U.S. National Library of Medicine.
  • Clinical trial number NCT01184820 for "Trial to Evaluate the Pharmacokinetics and Safety Profile of BAY94-9027 Following Single and Multiple Dose Administration" at ClinicalTrials.gov
  • Clinical trial number NCT01580293 for "A Trial Investigating Safety and Efficacy of Treatment With BAY94-9027 in Severe Hemophilia A (PROTECT-VIII)" at ClinicalTrials.gov
  • Clinical trial number NCT01775618 for "Safety and Efficacy of BAY94-9027 in Previously Treated Male Children With Haemophilia A" at ClinicalTrials.gov
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