[Recombinant activated factor VII in paediatric practice. Universal hemostatic agent?].
NovoSeven (eptacog alfa [activated]) is a concentrate of recombinant activated factor VII currently indicated in 3 types of situation: (1) hemorrhagic syndromes in patients with acquired haemophilia or constitutional A or B haemophilia with inhibitor; (2) Glanzmann thrombasthenia in patients with ineffective platelet transfusion due to alloimmunization; (3) constitutional factor VII deficiency. NovoSeven is also used, off label, in a very large number of bleeding conditions or bleeding risk especially in adult's trauma; abdominal, cardiac or chest surgery; gastroenterology; gynaecology and obstetrics or haematology. In these situations and sometimes in the context of randomized trials, against placebo studies, a large number of publications are reported, with variable scientific value according to evidence-based proofs. Studies conducted in children are far fewer and most of them did not achieve a high-level of evidence. However, we wanted to write a synthesis of the paediatric experience reported in the literature. Whereas it is important to build on work done in adults published data, the conclusions drawn from them are not perfectly applicable in paediatric practice. This bibliographical work is not an accurate guide of recommendations but should allow everyone to get an idea of situations where the use of this drug should or might be considered.
Monpoux
F
F
Unité d'hémato-oncologie infantile, service de pédiatrie, hôpital de l'Archet II, 151, route de Saint-Antoine-de-Ginestière, 06202 Nice cedex 3, France. monpoux.f@chu-nice.fr
Chambost
H
H
Haouy
S
S
Benadiba
J
J
Sirvent
N
N
D000328:Adult; D002648:Child; D019317:Evidence-Based Medicine; D015942:Factor VIIa / Q000145:classification / Q000235:genetics* / Q000627:therapeutic use; D006467:Hemophilia A / Q000188:drug therapy; D002836:Hemophilia B / Q000188:drug therapy; D006470:Hemorrhage / Q000188:drug therapy; D006490:Hemostatics / Q000627:therapeutic use*; D006801:Humans; D010919:Placebos; D011994:Recombinant Proteins / Q000145:classification / Q000627:therapeutic use
D006490:Hemostatics; D010919:Placebos; D011994:Recombinant Proteins; C103587:recombinant FVIIa; D015942:Factor VIIa