Safety analysis ofrFVIIa with emicizumab dosing in congenital hemophilia A with inhibitors: Experience from theHAVENclinical program

Author:

Levy Gallia G.1,Asikanius Elina2,Kuebler Peter1,Benchikh El Fegoun Soraya3,Esbjerg Sille4,Seremetis Stephanie5

Affiliation:

1. Genentech Inc. South San Francisco California

2. F. Hoffmann‐La Roche Ltd Basel Switzerland

3. Novo Nordisk Health Care AG Zürich Switzerland

4. Novo Nordisk A/S Søborg Denmark

5. Novo Nordisk Inc. Princeton New Jersey

Funder

F. Hoffmann-La Roche

Publisher

Wiley

Subject

Hematology

Reference20 articles.

1. FDA.Highlights of prescribing information ‐ NovoSeven®RT Coagulation Factor VIIa (Recombinant). Available athttps://wwwfdagov/downloads//ucm056954pdf. 2014; Accessed 14 Sep 2018.

2. EMA.NovoSeven summary of product characteristics. Available athttp://wwwemaeuropaeu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000074/WC500030873pdf. 2016; Accessed 14 Sep 2018.

3. EMA.Summary of product characteristics ‐ Hemlibra. Available athttp://wwwemaeuropaeu/docs/en_GB/document_library/EPAR_-_Product_Information/human/004406/WC500244743pdf. 2018; Accessed 14 Sep 2018.

4. In vitro thrombin generation testing and in vivo venous stasis model for assessing the pro‐coagulant effects of FVIII, emicizumab, rFVIIa, and aPCC;Adamkewicz JI;Haemophilia,2017

5. Recombinant coagulation factor VIIa – from molecular to clinical aspects of a versatile haemostatic agent

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