Wirkstoffe & Arzneimittelsicherheit

Wechselwirkungen · Prezista

PREZISTA 400 mg film-coated tablets PREZISTA 800 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 93–94

HOS-116603 · Präparat HOS-094447

93  Tenofovir disoproxil tenofovir AUC ↑ 22% Monitoring of renal function may 245 mg once daily‡ tenofovir Cmin ↑ 37% be indicated when boosted tenofovir Cmax ↑ 24% PREZISTA is given in # darunavir AUC ↑ 21% combination with tenofovir # darunavir Cmin ↑ 24% disoproxil, particularly in patients # with underlying systemic or renal darunavir Cmax ↑ 16% disease, or in patients taking (↑ tenofovir from effect on MDR-1 nephrotoxic agents. transport in the renal tubules) PREZISTA co-administered with cobicistat lowers the creatinine clearance. Refer to section 4.4 if creatinine clearance is used for dose adjustment of tenofovir disoproxil. Emtricitabine/tenofovir Tenofovir alafenamide ↔ The recommended dose of alafenamide Tenofovir ↑ emtricitabine/tenofovir alafenamide is 200/10 mg once daily when used with boosted PREZISTA. Abacavir Not studied. Based on the different Boosted PREZISTA can be used Emtricitabine elimination pathways of the other NRTIs with these NRTIs without dose Lamivudine zidovudine, emtricitabine, stavudine, adjustment. Stavudine lamivudine, that are primarily renally Zidovudine excreted, and abacavir for which PREZISTA co-administered with metabolism is not mediated by CYP450, cobicistat lowers the creatinine no interactions are expected for these clearance. Refer to section 4.4 if medicinal compounds and boosted creatinine clearance is used for PREZISTA. dose adjustment of emtricitabine or lamivudine. Non-nucleo(s/t)ide reverse transcriptase inhibitors (NNRTIs) Efavirenz efavirenz AUC ↑ 21% Clinical monitoring for central 600 mg once daily efavirenz Cmin ↑ 17% nervous system toxicity associated efavirenz Cmax ↑ 15% with increased exposure to # darunavir AUC ↓ 13% efavirenz may be indicated when # darunavir Cmin ↓ 31% PREZISTA co-administered with # low dose ritonavir is given in darunavir Cmax ↓ 15% combination with efavirenz. (↑ efavirenz from CYP3A inhibition) (↓ darunavir from CYP3A induction) Efavirenz in combination with PREZISTA/ritonavir 800/100 mg once daily may result in sub-optimal darunavir Cmin. If efavirenz is to be used in combination with PREZISTA/ritonavir, the PREZISTA/ritonavir 600/100 mg twice daily regimen should be used (see section 4.4).

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): tenofovir (HOS-088083) tenofovir alafenamide (HOS-110476) stavudine (HOS-088080) cobicistat (HOS-088111) creatinine (HOS-086273) tenofovir disoproxil (HOS-108843) lamivudine (HOS-085829) zidovudine (HOS-085837) efavirenz (HOS-087947) ritonavir (HOS-084521) abacavir (HOS-088077) emtricitabine (HOS-085840)