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Rekombinanter Faktor VIIa

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Transfusionsassoziierte Pharmakotherapie

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Zusammenfassung

Rekombinanter aktivierter Faktor VII (rFVIIa) ist ein Gerinnungsenzym, das nach hochdosierter intravenöser Gabe eine massive Thrombinbildung (Thrombinburst) induziert und dadurch hämostyptisch wirkt. Für diese Wirkung essentiell sind ausreichend hohe Plasmaspiegel der Gerinnungsfaktoren X, V und II sowie von Fibrinogen und eine ausreichend hohe Thrombozytenzahl. Eine Hypothermie und eine azidotische Stoffwechsellage sind weitere Faktoren, die zu einer Einschränkung der rFVIIa-Wirkung führen können. Vor der Gabe von rFVIIa sollten deswegen entsprechende Korrekturmaßnahmen eingeleitet werden.

Zugelassene Indikationen für rFVIIa umfassen die Prophylaxe und Therapie von Blutungen bei Patienten mit hereditärem Faktor-VII-Mangel, angeborener Hämophilie A/B mit hochtitrigem Hemmkörper, Auto-AK gegen Faktor VIII oder IX, Thrombasthenie Glanzmann. Durch die Behandlung mit rFVIIa wird das Risiko für arterielle thromboembolische Ereignisse leicht erhöht. Deswegen sollte die Indikationsstellung für die rFVIIa-Gabe bei Patienten mit arteriellen Gefäßerkrankungen besonders restriktiv gestellt werden. Eine absolute Kontraindikation gegen die rFVIIa-Gabe besteht bei bedrohlichen Blutungen nicht.

RCTs konnten bei orthotoper Lebertransplantation oder herzchirurgischen Eingriffen keine Vorteile für rFVIIa belegen. Eine erste kleinere RCT bei Traumablutung senkte die Morbidität, eine größere Nachfolgestudie konnte diesen Vorteil nicht bestätigen. Ähnliches gilt auch für Patienten mit intrazerebraler Blutung. Ein Überlebensvorteil konnte in einer Folgestudie für dieses Patientenkollektiv nicht belegt werden.

Basierend auf den Ergebnissen großer klinischer Studien wird rFVIIa als Ultima-ratio-Therapie bei therapierefraktären Blutungen eingesetzt. Allerdings wird aufgrund der erhöhten Inzidenz von arteriellen thromboembolischen Komplikationen unter rFVIIa eine sorgfältige Abwägung zwischen möglichem klinischen Nutzen und der assoziierten Komplikationsrate gefordert.

Die Dosierung beträgt 90 μg/kg; ggf. Repetitionsdosis nach 2 h. Der Ausschluss eines Heparineffekts ist Voraussetzung für klinische Wirksamkeit: Fibrinogen ≥100–150 mg/dl, Thrombozyten ≥50.000/nl, pH ≥7,2.

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Authors and Affiliations

  1. Institut für Exp. Hämatologie und Transfusionsmedizin, Universitätsklinikum Bonn, Sigmund-Freud-Str. 25, 53105, Bonn, Deutschland

    Prof. Dr. med. Bernd Pötzsch

  2. Klinik für Anaesthesiologie, Universitätsklinikum Aachen, Pauwelsstr. 30, 52074, Aachen, Deutschland

    Priv.-Doz. Dr. Dr. med. Oliver Grottke

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  1. Prof. Dr. med. Bernd Pötzsch
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  1. Soltau, Germany

    Günter Singbartl

  2. Department of Anesthesiology, Milton S. Hershey Medical Center, Hershey, USA

    Kai Singbartl

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Pötzsch, B., Grottke, O. (2016). Rekombinanter Faktor VIIa. In: Singbartl, G., Singbartl, K. (eds) Transfusionsassoziierte Pharmakotherapie. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-662-47258-3_6

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