Wirkstoffe & Arzneimittelsicherheit

Wechselwirkungen · Braftovi

Braftovi 50 mg hard capsules Braftovi 75 mg hard capsules · Abschnitt 4.5 · PDF-Seite 11

HOS-140060 · Präparat HOS-098444

CYP3A4 inhibitors Co-administration of moderate (diltiazem) and strong (posaconazole) CYP3A4 inhibitors with single doses of encorafenib in healthy volunteers resulted in a 2 and 3-fold increase in the area under the concentration-time curve (AUC), respectively and in 44.6% and 68.3% increase in maximum encorafenib concentration (Cmax) respectively. Model based predictions indicate that the effect of posaconazole after repeated administrations could be similar for AUC (3-fold increase) and slightly greater for Cmax (2.7-fold increase). Model-based predictions for ketoconazole suggest an increase of approx. 5-fold for encorafenib AUC and 3 to 4- fold for encorafenib Cmax after administration of encorafenib 450 and 300 mg QD, respectively. Therefore, concomitant administration of encorafenib with strong CYP3A4 inhibitors should be avoided (due to increased encorafenib exposure and potential increase in toxicity, see section 5.2). Examples of strong CYP3A4 inhibitors include, but are not limited to, ritonavir, itraconazole, clarithromycin, telithromycin, posaconazole and grapefruit juice. If concomitant use of a strong CYP3A inhibitor is unavoidable, patients should be carefully monitored for safety. Moderate CYP3A4 inhibitors should be co-administered with caution. Examples of moderate CYP3A4 inhibitors include, but are not limited to, amiodarone, erythromycin, fluconazole, diltiazem, amprenavir and imatinib. When encorafenib is co-administered with a moderate CYP3A inhibitor, patients should be carefully monitored for safety.

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): diltiazem (HOS-086288) ketoconazole (HOS-084513) grapefruit juice (HOS-088787) imatinib (HOS-110212) telithromycin (HOS-084523) itraconazole (HOS-084516) fluconazole (HOS-087945) clarithromycin (HOS-084517) erythromycin (HOS-084514) amprenavir (HOS-086183) ritonavir (HOS-084521) amiodarone (HOS-085596) posaconazole (HOS-085622)