Wechselwirkungen · Xtandi
Xtandi - 40 mg film-coated tablets Xtandi - 80 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 37
HOS-127929 · Präparat HOS-096479
P-gp substrates In vitro data indicate that enzalutamide may be an inhibitor of the efflux transporter P-gp. A mild inhibitory effect of enzalutamide, at steady-state, on P-gp was observed in a study in patients with prostate cancer that received a single oral dose of the probe P-gp substrate digoxin before and concomitantly with enzalutamide (concomitant administration followed at least 55 days of once daily dosing of 160 mg enzalutamide). The plasma levels of digoxin were measured using a validated liquid chromatography-tandem mass spectrometry assay. The AUC and Cmax of digoxin increased by 33% and 17%, respectively. Medicinal products with a narrow therapeutic range that are substrates for P-gp (e.g. colchicine, dabigatran etexilate, digoxin) should be used with caution when administered concomitantly with Xtandi and may require dose adjustment to maintain optimal plasma concentrations.
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): digoxin (HOS-086172) colchicine (HOS-086147) dabigatran etexilate (HOS-086233)
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-07-29T10:07:00Z · SHA-256 2bf5e532360d917a40a8717a4c2398563991ca5e2d824233a2adf92bb006bfb9 · Passage c9752e20fdbfe2c2951ff805b0b561c51b2a789c917ed5274a176333284914df · Zeichen 6208–7111 im Abschnitt