Damoctocog alfa pegol

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]

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

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. "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. "Jivi (antihemophilic factor- recombinant pegylated-aucl kit". DailyMed. 30 August 2018. Retrieved 1 October 2020.
  5. "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. "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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