Biology:Damoctocog alfa pegol
| Clinical data | |
|---|---|
| Trade names | Jivi |
| Other names | BAY94-9027, antihemophilic factor (recombinant), PEGylated-aucl |
| AHFS/Drugs.com | Monograph |
| License data |
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| Pregnancy category |
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| Routes of administration | Intravenous |
| ATC code | |
| Legal status | |
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| Identifiers | |
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| Chemical and physical data | |
| Formula | C7445H11318N1984O2184S69 |
| Molar mass | 165774.28 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
- ↑ 1.0 1.1 "Jivi". 6 April 2023. https://www.tga.gov.au/resources/auspmd/jivi.
- ↑ "Jivi damoctocog alfa pegol 250 IU powder for injection vial with diluent syringe (384590)". 28 March 2023. https://www.tga.gov.au/resources/artg/384590.
- ↑ "Search Page - Drug and Health Product Register". 23 October 2014. https://hpr-rps.hres.ca/reg-content/regulatory-decision-summary-detail.php?lang=en&linkID=RDS00474.
- ↑ 4.0 4.1 4.2 "Jivi (antihemophilic factor- recombinant pegylated-aucl kit". 30 August 2018. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f04e5bd5-d7e2-453b-a407-2616d81a695d.
- ↑ 5.0 5.1 5.2 5.3 "Jivi EPAR". 24 September 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/jivi. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ↑ 6.0 6.1 "Jivi". 29 August 2018. https://www.fda.gov/vaccines-blood-biologics/jivi.
This article incorporates text from this source, which is in the public domain.
- ↑ "Damoctocog Alfa Pegol: A Review in Haemophilia A". Drugs 79 (10): 1147–1156. July 2019. doi:10.1007/s40265-019-01152-7. PMID 31218660.
External links
- "Damoctocog alfa pegol". Drug Information Portal. U.S. National Library of Medicine. https://druginfo.nlm.nih.gov/drugportal/name/damoctocog%20alfa%20pegol.
- 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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