Wirkstoffe & Arzneimittelsicherheit

Wechselwirkungen · Prezista

PREZISTA 75 mg film-coated tablets PREZISTA 150 mg film-coated tablets PREZISTA 600 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 60–61

HOS-116525 · Präparat HOS-094447

60  Rifabutin rifabutin AUC** ↑ 55% A dosage reduction of rifabutin by 150 mg once every other rifabutin Cmin** ↑ ND 75% of the usual dose of day rifabutin Cmax** ↔ 300 mg/day (i.e. rifabutin 150 mg darunavir AUC ↑ 53% once every other day) and darunavir Cmin ↑ 68% increased monitoring for rifabutin related adverse events is warranted darunavir Cmax ↑ 39% ** in patients receiving the sum of active moieties of rifabutin (parent combination with PREZISTA drug + 25-O-desacetyl metabolite) co-administered with ritonavir. In case of safety issues, a further The interaction trial showed a increase of the dosing interval for comparable daily systemic exposure for rifabutin and/or monitoring of rifabutin between treatment at 300 mg rifabutin levels should be once daily alone and 150 mg once every considered. other day in combination with Consideration should be given to PREZISTA/ritonavir (600/100 mg twice official guidance on the daily) with an about 10-fold increase in appropriate treatment of the daily exposure to the active tuberculosis in HIV infected metabolite 25-O-desacetylrifabutin. patients. Furthermore, AUC of the sum of active Based upon the safety profile of moieties of rifabutin (parent drug PREZISTA/ritonavir, the increase + 25-O-desacetyl metabolite) was in darunavir exposure in the increased 1.6-fold, while Cmax remained presence of rifabutin does not comparable. warrant a dose adjustment for Data on comparison with a 150 mg once PREZISTA/ritonavir. daily reference dose is lacking. Based on pharmacokinetic modeling, this dosage reduction of (Rifabutin is an inducer and substrate of 75% is also applicable if patients CYP3A.) An increase of systemic receive rifabutin at doses other exposure to darunavir was observed when than 300 mg/day. PREZISTA co-administered with 100 mg ritonavir was co-administered with rifabutin (150 mg once every other day). ANTINEOPLASTICS Dasatinib Not studied. PREZISTA is expected to Concentrations of these medicinal Nilotinib increase these antineoplastic plasma products may be increased when Vinblastine concentrations. co-administered with PREZISTA Vincristine (CYP3A inhibition) with low dose ritonavir resulting in the potential for increased adverse events usually associated with these agents. Caution should be exercised when combining one of these antineoplastic agents with PREZISTA with low dose ritonavir.

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): dasatinib (HOS-086217) rifabutin (HOS-086262) vinblastine (HOS-086220) vincristine (HOS-086219) ritonavir (HOS-084521) nilotinib (HOS-086218)