Wirkstoffe & Arzneimittelsicherheit

Wechselwirkungen · Busulfan Fresenius Kabi

Busulfan Fresenius Kabi 6 mg/ml concentrate for solution for infusion · Abschnitt 4.5 · PDF-Seite 7

HOS-129997 · Präparat HOS-096825

Either phenytoin or benzodiazepines were administered for seizure prophylaxis in patients participating to the clinical trials conducted with intravenous busulfan (see section 4.2 and 4.4). The concomitant systemic administration of phenytoin to patients receiving high-dose of oral busulfan has been reported to increase busulfan clearance, due to induction of glutathion-S-transferase whereas no interaction has been reported when benzodiazepines such as diazepam, clonazepam or lorazepam have been used to prevent seizures with high-dose busulfan. No evidence of an induction effect of phenytoin has been seen on busulfan data. A phase II clinical trial was performed to evaluate the influence of seizure prophylaxis treatment on intravenous busulfan pharmacokinetics. In this study, 24 adult patients received clonazepam (0.025-0.03 mg/kg/day as IV continuous infusions) as anticonvulsant therapy and the PK data of these patients were compared to historical data collected in patients treated with phenytoin. The analysis of data through a population pharmacokinetic method indicated no difference on intravenous busulfan clearance between phenytoin and clonazepam based therapy and therefore similar busulfan plasma exposures were achieved whatever the type of seizure prophylaxis. No interaction was observed when busulfan was combined with 5 HT3 antiemetics such as ondansetron or granisetron.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): granisetron (HOS-086051) lorazepam (HOS-085981) diazepam (HOS-085904) clonazepam (HOS-116372) ondansetron (HOS-086052) phenytoin (HOS-084531)