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

Kód výsledku v 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>

Nalezeny alternativní kódy

RIV/00023736:_____/14:00010964

Výsledek na webu

<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>

Jazyk výsledku

angličtina

Název v původním jazyce

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

Popis výsledku v původním jazyce

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.

Název v anglickém jazyce

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

Popis výsledku anglicky

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.

Druh

J_x - Nezařazeno - Článek v odborném periodiku (Jimp, Jsc a Jost)

CEP obor

FD - Onkologie a hematologie

OECD FORD obor

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Projekt

—

Návaznosti

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Rok uplatnění

2014

Kód důvěrnosti údajů

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

Název periodika

Haemophilia

ISSN

1351-8216

e-ISSN

—

Svazek periodika

20

Číslo periodika v rámci svazku

1

Stát vydavatele periodika

GB - Spojené království Velké Británie a Severního Irska

Počet stran výsledku

9

Strana od-do

"e23"-"e31"

Kód UT WoS článku

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EID výsledku v databázi Scopus

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