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A new approach to treatment of bleeding episodes in young hemophilia patients: a single bolus megadose of recombinant activated factor VII (NovoSeven ® )
Author(s) -
Kenet G.,
Lubetsky A.,
Luboshitz J.,
Martinowitz U.
Publication year - 2003
Publication title -
journal of thrombosis and haemostasis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.947
H-Index - 178
eISSN - 1538-7836
pISSN - 1538-7933
DOI - 10.1046/j.1538-7836.2003.00059.x
Subject(s) - medicine , bolus (digestion) , regimen , anesthesia , surgery , dosing , bleed , intravenous bolus , recombinant factor viia , continuous infusion
Summary. Recombinant activated factor VII (rFVIIa, NovoSeven ® ) represents an effective treatment for hemophilia patients with inhibitors, but no consensus as to the best dosing regimen exists. We assessed the efficacy and safety of a rFVIIa ‘megadose’ (300 µg kg −1 bolus) as treatment for bleeds in three young inhibitor patients. Of 114 bleeds, 95 responded to a single dose. Pain relief was faster and therapy duration significantly shorter than with continuous infusion (CI) regimens or standard boluses (90 µg kg −1 every 3 h). Rebleeding occurred in 9.6% of cases and 19/114 episodes required a second bolus injection. Although rFVIIa consumption per bleed (median: 300 µg kg −1 ) was higher than with standard boluses (180–270 µg kg −1 ), patients found single bolus administration more convenient than recurrent injections or CI. With two exceptions, no complications occurred within 3 h of treatment, despite high FVII:C levels (median: 27.4 U mL −1 ; range: 19.8–54 U mL −1 ). Treatment of bleeds with a rFVIIa megadose in young inhibitor patients is effective and well tolerated.