Wirkstoffe & Arzneimittelsicherheit

Wechselwirkungen · Votubia

Votubia 2.5 mg tablets Votubia 5 mg tablets Votubia 10 mg tablets · Abschnitt 4.5 · PDF-Seite 11–12

HOS-214258 · Präparat HOS-155312

11  concentrations should be assessed at least 1 week after the addition of a moderate CYP3A4 or PgP inhibitor. If the moderate inhibitor is discontinued, consider a washout period of at least 2 to 3 days (average elimination time for most commonly used moderate inhibitors) before the Votubia dose is returned to the dose used prior to initiation of the co-administration. The everolimus trough concentration should be assessed at least 1 week later (see sections 4.2 and 4.4). Grapefruit juice or other Not studied. Increased exposure Combination should be avoided. food affecting CYP3A4/PgP expected (the effect varies widely). Potent and moderate CYP3A4 inducers Rifampicin AUC ↓63% Avoid the use of concomitant potent (range 0-80%) CYP3A4 inducers. Cmax ↓58% (range 10-70%) For patients with renal Dexamethasone Not studied. Decreased angiomyolipoma associated with exposure expected. TSC: Antiepileptics (e.g. Not studied. Decreased If patients require co-administration carbamazepine, exposure expected. of a potent CYP3A4 inducer, a phenobarbital, phenytoin) Votubia dose increase from 10 mg Efavirenz, nevirapine Not studied. Decreased daily up to 20 mg daily should be exposure expected. considered using 5 mg increments or less applied on Day 4 and 8 following start of the inducer. This dose of Votubia is predicted to adjust the AUC to the range observed without inducers. However, there are no clinical data with this dose adjustment. If treatment with the inducer is discontinued, consider a washout period of at least 3 to 5 days (reasonable time for significant enzyme de-induction) before the Votubia dose is returned to the dose used prior to initiation of the co-administration (see also Therapeutic drug monitoring in section 4.2).

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): phenobarbital (HOS-085617) carbamazepine (HOS-085618) grapefruit juice (HOS-088787) dexamethasone (HOS-084535) efavirenz (HOS-087947) nevirapine (HOS-088064) phenytoin (HOS-084531)