Damoctocog alfa pegol

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Damoctocog alfa pegol - Wikipedia

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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

^ ^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

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

Antihemorrhagics (B02)

Antihemorrhagics
(coagulation)

Systemic

Vitamin K	Phytomenadione (K₁) Menadione (K₃)
Coagulation factors	intrinsic: VIII/(Damoctocog alfa pegol, Efanesoctocog alfa, Efmoroctocog alfa, Moroctocog alfa, Susoctocog alfa, Turoctocog alfa, Valoctocogene roxaparvovec, von Willebrand factor) IX/(Fidanacogene elaparvovec, Nonacog alfa) extrinsic: VII/Eptacog alfa common: X II/Thrombin I/Fibrinogen XIII/Catridecacog combinations: Prothrombin complex concentrate (II, VII, IX, X, protein C and S)
Other systemic	Batroxobin Carbazochrome Concizumab Etamsylate Fostamatinib Marstacimab thrombopoietin receptor agonist Romiplostim Avatrombopag Eltrombopag Lusutrombopag Rafutrombopag

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