Dienstag, 29. Januar 2008

Intravenöses Aprepitant zugelassen

Fosaprepitant-Dimeglumin (IVEMEND) wurde von der europäischen Zulassungsbehörde zur intravenösen Prävention von Übelkeit und Erbrechen nach Chemotherapie zugelassen. Fosaprepitant-Dimeglumin (Abb. 1) ist ein Prodrug von oral applizierbarem Aprepitant (EMEND) (Abb. 2)

Es wird im Körper nach parenteraler Gabe rasch zu Aprepitant dephosphoryliert.
Fosaprepitant kann an Tag 1 der Behandlung vor der Chemotherapie alternativ zur oralen Darreichungsform eingesetzt werden. Das empfohlene Therapieregime für Tag 2 und 3 ist nach wie vor je eine 80-mg-Kapsel EMEND®, um dien Patienten über 5 Tage vor Übelkeit und Erbrechen zu schützen. Die Zulassung basiert auf einer Studie, die die Bioäquivalenz von 115 mg intravenös verabreichtem Fosaprepitant im Vergleich zu 125 mg oral verabreichtem Aprepitant bei guter Verträglichkeit gezeigt hat .

Quellen:
www.emea.europa.eu/pdfs/human/opinion/Ivemend_53703107en.pdf - 2007-12-20
Pressemitteilung MSD Sharp & Dohme vom 29. Januar 2008

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