Wirkstoffe & Arzneimittelsicherheit

Wechselwirkungen · Akynzeo

Akynzeo 235 mg/0.25 mg powder for concentrate for solution for infusion · Abschnitt 4.5 · PDF-Seite 22

HOS-130744 · Präparat HOS-096947

Fosnetupitant/palonosetron powder for concentrate for solution for infusion is unlikely to interact with medicinal products which are P-gp substrates. Netupitant is not a substrate for P-gp. When netupitant was administered on Day 8 of a 12-day regimen of digoxin, no changes in digoxin pharmacokinetics were observed. Inhibition of the efflux transporter BCRP by fosenetupitant netupitant and its metabolites is unlikely and, if it occurs, of scarce clinical relevance. In vitro data shows that fosnetupitant inhibits UGT2B7 / UGT2B15 and netupitant inhibits UGT2B7, the magnitude of such an effect in the clinical setting is not established. Caution is therefore recommended when netupitant and fosnetupitant is combined with an oral substrate of this enzyme (e.g. zidovudine, valproic acid, morphine). In vitro data suggests that netupitant inhibits the efflux of transporter BCRP. The clinical relevance of this effect is not established. In vitro data show that netupitant is a P-gp inhibitor. In a study performed in healthy volunteers, netupitant does not affect the exposure of digoxin, a P-gp substrate, whereas it increases its Cmax by 1.09 fold [90%CI 0.9-1.31]. It is not excluded that this effect may be more marked, and then clinically relevant, in cancer patients, notably those having abnormal renal function. Therefore, caution is recommended when netupitant is combined with digoxin or with other P-gp substrates such as dabigatran, or colchicine.

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): valproic acid (HOS-088515) digoxin (HOS-086172) dabigatran (HOS-112096) morphine (HOS-086053) fosnetupitant (HOS-130728) zidovudine (HOS-085837) colchicine (HOS-086147)