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出典(authority):フリー百科事典『ウィキペディア（Wikipedia）』「2018/01/30 14:14:00」(JST)

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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.^[1]^[2] It was first launched in Germany in January 2014 and has been approved in the US, EU and Japan.^[3]

Medical uses

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.^[4]

Benefits and risks

In a study conducted with 150 patients aged 12 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 12 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.^[5]

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.^[4]

Preparation

As 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.^[6]

Difference between NovoSeven and NovoEight

Even 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.^[7]

References

^ NovoEight UK Drug Information
^ H. Spreitzer (7 January 2014). "Neue Wirkstoffe – NovoEight". Österreichische Apothekerzeitung (in German) (1/2014): 18.
^ Novo Nordisk annual report 2013
^ ^a ^b "FDA Approval Document" (PDF). Retrieved 2014-04-27.
^ "European Drug Assessment Report" (PDF). Retrieved 2014-04-27.
^ Haddley K. "Turoctog alfa for the treatment of hemophilia A". Drugs today. Retrieved 2014-04-07.
^ "How NovoSeven Works". Retrieved 2014-04-27.

UpToDate Contents

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1. 血友病A・血友病B：予防を含めた日常的なマネージメント hemophilia a and b routine management including prophylaxis
2. 血友病患者に生じる慢性合併症と加齢に伴い生じる併存症 chronic complications and age related comorbidities in people with hemophilia
3. 血友病A・血友病Bに伴う出血の治療と周術期マネージメント treatment of bleeding and perioperative management in hemophilia a and b
4. 血友病患者における第VIIIおよび第IX因子阻害物質 factor viii and factor ix inhibitors in patients with hemophilia
5. 血漿分画製剤および組換えDNA産生凝固因子 plasma derivatives and recombinant dna produced coagulation factors

English Journal

Safety and efficacy of a glycoPEGylated rFVIII (turoctocog alpha pegol, N8-GP) in paediatric patients with severe haemophilia A.

Meunier S1, Alamelu J, Ehrenforth S, Hanabusa H, Abdul Karim F, Kavakli K, Khodaie M, Staber J, Stasyshyn O, Yee DL, Rageliene L.
Thrombosis and haemostasis.Thromb Haemost.2017 Jul 6;117(9). doi: 10.1160/TH17-03-0166. [Epub ahead of print]
PMID 28692108

First report on the safety and efficacy of an extended half-life glycoPEGylated recombinant FVIII for major surgery in severe haemophilia A.

Hampton K1, Chowdary P2, Dunkley S3, Ehrenforth S4, Jacobsen L4, Neff A5, Santagostino E6, Sathar J7, Takedani H8, Takemoto CM9, Négrier C10.
Haemophilia : the official journal of the World Federation of Hemophilia.Haemophilia.2017 May 4. doi: 10.1111/hae.13246. [Epub ahead of print]
PMID 28470862

Measuring FVIII activity of glycopegylated recombinant factor VIII, N8-GP, with commercially available one-stage clotting and chromogenic assay kits: a two-centre study.

Hillarp A1, Bowyer A2, Ezban M3, Persson P4, Kitchen S2.
Haemophilia : the official journal of the World Federation of Hemophilia.Haemophilia.2017 May;23(3):458-465. doi: 10.1111/hae.13168. Epub 2017 Feb 14.
PMID 28198071

Japanese Journal

治療歴のある血友病A患者におけるBドメイン切断型遺伝子組換え第VIII因子製剤の安全性と有効性：全集団と日本人被験者集団のデータ比較

日本血栓止血学会誌 25(1), 75-81, 2014
NAID 130003393343

「ツロクトコグアルファ」

Turoctocog alfa
Clinical data
Trade names	NovoEight
AHFS/Drugs.com	UK Drug Information
License data	EU EMA: by INN;
ATC code	B02BD02 (WHO);
Legal status
Legal status	In general: ℞ (Prescription only);
Identifiers
ChemSpider	none;
KEGG	D10227;