Safety of recombinant activated factor VII (rFVIIa) in patients with congenital haemophilia with inhibitors: overall rFVIIa exposure and intervals following high (>240 ?g kg-1) rFVIIa doses across clinical trials and registries

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00023736%3A_____%2F13%3A00010964" target="_blank" >RIV/00023736:_____/13:00010964 - isvavai.cz</a>

Alternative codes found

RIV/00023736:_____/14:00010964

Result on the web

<a href="http://dx.doi.org/10.1111/hae.12329" target="_blank" >http://dx.doi.org/10.1111/hae.12329</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1111/hae.12329" target="_blank" >10.1111/hae.12329</a>

Result language

angličtina

Original language name

Safety of recombinant activated factor VII (rFVIIa) in patients with congenital haemophilia with inhibitors: overall rFVIIa exposure and intervals following high (>240 ?g kg-1) rFVIIa doses across clinical trials and registries

Original language description

Data regarding on-demand or prophylactic rFVIIa dosing, TE incidence and subsequent BPA dosing after high rFVIIa doses were compiled from multiple sources incorporating safety surveillance. A total of 61 734 rFVIIa doses were reported in 481 patients treated for 3947 bleeds and for 43 135 prophylaxis days. Over half (52%) exceeded 120 ?g kg-1, 37% exceeded 160 ?g kg-1 and 15% exceeded 240 ?g kg-1. Subsequent doses of BPA(s) were administered after 38% of initial and 49% of any rFVIIa dose >240 ?g kg-1,and were most frequently administered 24 h after initial (40%) or any (53%) doses >240 ?g kg-1. No TEs were reported. The findings of this analysis show that rFVIIa doses >90 ?g kg-1 are utilized for 'real-world' treatment of children and adults. When additional BPA was administered following an rFVIIa dose >240 ?g kg-1, reported intervals were prolonged, often 24 h. No safety issues were identified in the 61 734 doses analysed.

Czech name

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Czech description

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Type

J_x - Unclassified - Peer-reviewed scientific article (Jimp, Jsc and Jost)

CEP classification

FD - Oncology and haematology

OECD FORD branch

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Project

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Continuities

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Publication year

2014

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

Haemophilia

ISSN

1351-8216

e-ISSN

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Volume of the periodical

20

Issue of the periodical within the volume

1

Country of publishing house

GB - UNITED KINGDOM

Number of pages

9

Pages from-to

"e23"-"e31"

UT code for WoS article

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EID of the result in the Scopus database

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