Abstract |
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 micro g 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 micro g 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 micro g kg(-1)) was higher than with standard boluses (180-270 micro g 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.
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Authors | G Kenet, A Lubetsky, J Luboshitz, U Martinowitz |
Journal | Journal of thrombosis and haemostasis : JTH
(J Thromb Haemost)
Vol. 1
Issue 3
Pg. 450-5
(Mar 2003)
ISSN: 1538-7933 [Print] England |
PMID | 12871449
(Publication Type: Comparative Study, Journal Article)
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Chemical References |
- Recombinant Proteins
- Factor VII
- recombinant FVIIa
- Factor VIIa
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Topics |
- Adult
- Dose-Response Relationship, Drug
- Drug Evaluation
- Factor VII
(administration & dosage)
- Factor VIIa
- Hemophilia A
(complications, drug therapy)
- Hemorrhage
(etiology, prevention & control)
- Humans
- Infusions, Parenteral
- Injections
- Pain
(drug therapy, prevention & control)
- Recombinant Proteins
(administration & dosage)
- Secondary Prevention
- Time Factors
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