Wirkstoffe & Arzneimittelsicherheit

Wechselwirkungen · Balversa

Balversa 3 mg film-coated tablets Balversa 4 mg film-coated tablets Balversa 5 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 9

HOS-151047 · Präparat HOS-100442

Strong or moderate CYP3A4 inducers Co-administration with carbamazepine, a strong CYP3A4 and weak CYP2C9 inducer leads to decreased erdafitinib exposure. Mean ratios of Cmax and AUC∞ for erdafitinib was 65.4% (90% CI: 60.8, 70.5) and 37.7% (90% CI: 35.4, 40.2), respectively, when co-administered with carbamazepine relative to erdafitinib alone. Avoid co-administration of Balversa with strong CYP3A4 inducers (such as apalutamide, enzalutamide, lumacaftor, ivosidenib, mitotane, rifapentine, rifampicin, carbamazepine, phenytoin, and St. John’s wort). If Balversa is co-administered with a moderate CYP3A4 inducer (such as dabrafenib, bosentan, cenobamate, elagolix, efavirenz, etravirine, lorlatinib, mitapivat, modafinil, pexidartinib, phenobarbital, primidone, repotrectinib, rifabutin, sotorasib, telotristat ethyl), the dose should be cautiously increased by 1 to 2 mg and adjusted gradually every two to three weeks based on clinical monitoring for adverse reactions, not to exceed 9 mg. If the moderate CYP3A4 inducer is discontinued, the Balversa dose may be adjusted as tolerated (see sections 4.2 and 4.4).

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RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): lumacaftor (HOS-139029) phenobarbital (HOS-085617) modafinil (HOS-090546) carbamazepine (HOS-085618) rifabutin (HOS-086262) apalutamide (HOS-086212) sotorasib (HOS-147831) etravirine (HOS-088088) dabrafenib (HOS-109452) telotristat ethyl (HOS-141158) mitapivat (HOS-147878) mitotane (HOS-112479) elagolix (HOS-112109) lorlatinib (HOS-140195) rifapentine (HOS-116386) ivosidenib (HOS-112046) efavirenz (HOS-087947) bosentan (HOS-086291) phenytoin (HOS-084531) repotrectinib (HOS-151068) enzalutamide (HOS-116829) pexidartinib (HOS-150766) cenobamate (HOS-146930) primidone (HOS-090551)