Turoctocog alfa (trade name NovoEight) is a recombinant antihemophilic factor VIII used for the treatment of and prophylaxis of bleeding patients with haemophilia A. It is marketed by Novo Nordisk.[7][9][13] It was approved in the United States, the European Union, and Japan in 2013.[14][15][11][9]
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| Trade names | NovoEight, Esperoct |
| Other names | recombinant antihemophilic factor |
| AHFS/Drugs.com | Monograph |
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| Routes of administration | Intravenous (IV) |
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| Formula | C7480H11379N1999O2194S68 |
| Molar mass | 166594.19 g·mol−1 |
Medical uses
editTuroctocog alfa is indicated for the treatment and prophylaxis of bleeding in adults and children with haemophilia A (congenital factor VIII deficiency).[11]
Turoctocog alfa pegol is indicated for the treatment and prophylaxis of bleeding in adults and children twelve years and above with haemophilia A (congenital factor VIII deficiency).[12]
In the safety and efficacy trial for prevention and treatment of bleeds, in hemophilia patients the success rate for treatment of bleeds was 84.5% (excluding bleeds for which there was no outcome reported) and out of a total of nine surgeries in nine patients performed during the trial, haemostasis was successful in all the surgeries and no treatment failures were reported. It is also used for perioperative management and routine prophylaxis to prevent or reduce the frequency of bleeding episodes. Turoctocog alfa is not indicated for the treatment of von Willebrand disease.[16][9]
Benefits and risks
editIn a study conducted with 150 patients aged twelve and above, adolescents after using turoctocog alfa as a treatment, had an average of 5.55 bleedings per year while the adults had an average of 6.68 bleeding per year. According to data, turoctocog alfa was considered an 'excellent' treatment for 403 out of 499 bleeding episodes. In another study involving 63 patients aged less than twelve years, children had an average of 5.33 bleedings per year after using turoctocog alfa as hemophilia treatment. In this study too turoctocog alfa was considered as an 'excellent' treatment for 116 out of 126 bleeding episodes.[17]
Alongside the benefits, a few of the common turoctocog alfa adverse effects would be injection site reaction, pyrexia and augmented liver enzyme levels. Rare cases of allergic reactions have been reported as well. There is a possibility of patients developing hypersensitivity to the drug since it contains traces of hamster proteins. Activity-neutralising antibodies may be developed whereby expected plasma factor VIII activity levels may not be achieved and thus the bleeding would not be controlled as needed.[16]
Preparation
editAs cell culture, Chinese hamster ovary cells (CHO) are used in order to acquire proper processing of factor VIII protein, that has demonstrated good efficacy in thrombin generation and clot formation in preclinical evaluations in murine (mouse) and canine (dog) models of hemophilia A and in patient-derived whole blood.[18]
Difference between NovoSeven and NovoEight
editEven though both treatments are plasma-derived and recombinant analogues of blood clotting factors, NovoSeven is developed as a congenital FVIIa analogue for hemophilia A and B patients while NovoEight (turoctocog alfa) is for congenital FVIII deficiency. NovoSeven is called a bypassing agent because it skips the need for factor VIII or IX in people with inhibitors and activates factor X directly.[19]
Turoctocog alfa pegol
editIn February 2019, the FDA approved antihemophilic factor (recombinant), glycopegylated-exei (turoctocog alfa pegol) (Esperoct) for the treatment of hemophilia A.[20][10] Turoctocog alfa pegol was approved for medical use in the European Union in June 2019.[12]
References
edit- ^ "Antihemophilic factor Use During Pregnancy". Drugs.com. 20 January 2020. Archived from the original on 16 July 2020. Retrieved 11 March 2020.
- ^ "Prescription medicines: registration of new chemical entities in Australia, 2014". Therapeutic Goods Administration (TGA). 21 June 2022. Archived from the original on 10 April 2023. Retrieved 10 April 2023.
- ^ "Turoctocog alfa (rch)" (PDF). Archived (PDF) from the original on 16 May 2022. Retrieved 29 April 2023.
- ^ "Esperoct (Novo Nordisk Pharmaceuticals Pty Ltd)". Therapeutic Goods Administration (TGA). 23 June 2023. Retrieved 10 September 2023.
- ^ "Esperoct". Therapeutic Goods Administration (TGA). 19 June 2023. Retrieved 10 September 2023.
- ^ "Summary Basis of Decision (SBD) for Esperoct". Health Canada. 23 October 2014. Archived from the original on 31 May 2022. Retrieved 29 May 2022.
- ^ a b "NovoEight 250 IU powder and solvent for solution for injection - Summary of Product Characteristics (SmPC)". (emc). 23 December 2019. Archived from the original on 17 January 2021. Retrieved 11 March 2020.
- ^ "Esperoct 1000 IU powder and solvent for solution for injection - Summary of Product Characteristics (SmPC)". (emc). Archived from the original on 15 January 2021. Retrieved 2 October 2020.
- ^ a b c d "NovoEight (- antihemophilic factor, recombinant kit". DailyMed. 30 November 2018. Archived from the original on 24 March 2021. Retrieved 11 March 2020.
- ^ a b "Esperoct (antihemophilic factor- recombinant, glycopegylated-exei kit". DailyMed. 30 October 2019. Archived from the original on 26 March 2021. Retrieved 11 March 2020.
- ^ a b c "NovoEight EPAR". European Medicines Agency (EMA). 17 September 2018. Archived from the original on 30 October 2020. Retrieved 11 March 2020. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ^ a b c "Esperoct EPAR". European Medicines Agency (EMA). 24 April 2019. Archived from the original on 24 October 2020. Retrieved 11 March 2020.
- ^ Spreitzer H (7 January 2014). "Neue Wirkstoffe – NovoEight". Österreichische Apothekerzeitung (in German) (1/2014): 18.
- ^ "Novo Nordisk annual report 2013" (PDF). Novo Nordisk. Archived (PDF) from the original on 20 November 2017. Retrieved 11 March 2020.
- ^ "NovoEight". U.S. Food and Drug Administration (FDA). 19 July 2017. Archived from the original on 22 July 2017. Retrieved 11 March 2020.
- ^ a b "FDA Approval Document" (PDF). Food and Drug Administration. Archived (PDF) from the original on 7 February 2019. Retrieved 27 April 2014.
- ^ "European Drug Assessment Report" (PDF). Archived (PDF) from the original on 2 May 2014. Retrieved 27 April 2014.
- ^ Haddley K. "Turoctog alfa for the treatment of hemophilia A". Drugs today. Archived from the original on 2 May 2014. Retrieved 7 April 2014.
- ^ "How NovoSeven Works". Archived from the original on 2 May 2014. Retrieved 27 April 2014.
- ^ "Esperoct". U.S. Food and Drug Administration (FDA). 19 February 2019. STN: BL 125671. Archived from the original on 17 December 2019. Retrieved 11 March 2020.
