Damoctocog alfa pegol

Damoctocog alfa pegol

Clinical data
Trade names	Jivi
Other names	BAY94-9027, antihemophilic factor (recombinant), pegylated-aucl
AHFS/Drugs.com	Monograph
License data	US  DailyMed:  Damoctocog alfa
Pregnancy category	AU:B2 [1]
Routes of administration	Intravenous
ATC code	B02BD02 ( WHO )
Legal status
Legal status	AU: S4 (Prescription only) [1] [2] [3] CA: ℞-only / Schedule D [4] US: ℞-only [5] EU:Rx-only [6] In general: ℞ (Prescription only)
Identifiers
CAS Number	1363853-26-2
DrugBank	DB14700
UNII	BY4TSK952Y
KEGG	D10759
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 used to treat hemophilia A. ^{[5] [6]}

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

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. ^[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

1. "Jivi". Therapeutic Goods Administration (TGA). 6 April 2023. Archived from the original on 8 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. Archived from the original on 8 April 2023. Retrieved 7 April 2023.
3. https://www.tga.gov.au/resources/auspar/auspar-jivi ^{[ bare URL ]}
4. "Regulatory Decision Summary for Jivi". 23 October 2014. Archived from the original on 7 June 2022. Retrieved 7 June 2022.
5. "Jivi (antihemophilic factor- recombinant pegylated-aucl kit". DailyMed. 30 August 2018. Archived from the original on 11 October 2020. Retrieved 1 October 2020.
6. "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.
7. "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 .
8. 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

• 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