Damoctocog alfa pegol, sold under the brand name Jivi is a recombinant DNA-derived, Factor VIII concentrate used to treat hemophilia A.[5][6]
| Clinical data | |
|---|---|
| Trade names | Jivi |
| Other names | BAY94-9027, antihemophilic factor (recombinant), pegylated-aucl |
| AHFS/Drugs.com | Monograph |
| License data | |
| Pregnancy category |
|
| Routes of administration | Intravenous |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| UNII | |
| KEGG | |
| Chemical and physical data | |
| Formula | C7445H11318N1984O2184S69 |
| Molar mass | 165774.28 g·mol−1 |
The most common side effects include headache, cough, nausea, and fever.[5]
Damoctocog alfa pegol was approved for medical use in the United States in August 2018,[7] and in the European Union in November 2018.[6][8]
Medical uses
editIn 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.[7]
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).[6]
References
edit- ^ a b "Jivi". Therapeutic Goods Administration (TGA). 6 April 2023. Archived from the original on 8 April 2023. Retrieved 7 April 2023.
- ^ "Jivi damoctocog alfa pegol 250 IU powder for injection vial with diluent syringe (384590)". Therapeutic Goods Administration (TGA). 28 March 2023. Archived from the original on 8 April 2023. Retrieved 7 April 2023.
- ^ https://www.tga.gov.au/resources/auspar/auspar-jivi [bare URL]
- ^ "Regulatory Decision Summary for Jivi". 23 October 2014. Archived from the original on 7 June 2022. Retrieved 7 June 2022.
- ^ a b c "Jivi (antihemophilic factor- recombinant pegylated-aucl kit". DailyMed. 30 August 2018. Archived from the original on 11 October 2020. Retrieved 1 October 2020.
- ^ a b c d "Jivi EPAR". European Medicines Agency (EMA). 24 September 2018. Archived from the original on 2 October 2020. Retrieved 1 October 2020. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ^ a b "Jivi". U.S. Food and Drug Administration (FDA). 29 August 2018. STN: BL 125661. Archived from the original on 30 October 2020. Retrieved 1 October 2020.
This article incorporates text from this source, which is in the public domain.
- ^ 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.
External links
edit- 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
