Wirkstoffe & Arzneimittelsicherheit

Wechselwirkungen · Prezista

PREZISTA 100 mg/ml oral suspension · Abschnitt 4.5 · PDF-Seite 18–19

HOS-116385 · Präparat HOS-094447

18 ANTIMYCOBACTERIALS Rifampicin Not studied. Rifapentine and rifampicin The combination of rifapentine and Rifapentine are strong CYP3A inducers and have boosted PREZISTA is not been shown to cause profound decreases recommended. in concentrations of other protease inhibitors, which can result in virological The combination of rifampicin and failure and resistance development boosted PREZISTA is (CYP450 enzyme induction). During contraindicated (see section 4.3). attempts to overcome the decreased exposure by increasing the dose of other protease inhibitors with low dose ritonavir, a high frequency of liver reactions was seen with rifampicin. 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 Co-administration of PREZISTA rifabutin (150 mg once every other day). co-administered with cobicistat and rifabutin is not recommended. ANTINEOPLASTICS Dasatinib Not studied. Boosted PREZISTA is Concentrations of these medicinal Nilotinib expected to increase these antineoplastic products may be increased when Vinblastine plasma concentrations. co-administered with boosted Vincristine (CYP3A inhibition) PREZISTA 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 boosted PREZISTA.

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) protease (HOS-085623) rifabutin (HOS-086262) vinblastine (HOS-086220) cobicistat (HOS-088111) vincristine (HOS-086219) rifapentine (HOS-116386) ritonavir (HOS-084521) nilotinib (HOS-086218)