Wirkstoffe & Arzneimittelsicherheit

Wechselwirkungen · Darunavir Viatris (previously Darunavir Mylan)

Darunavir Viatris 75 mg film-coated tablets Darunavir Viatris 150 mg film-coated tablets Darunavir Viatris 300 mg film-coated tablets Darunavir Viatris 600 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 10

HOS-134477 · Präparat HOS-097580

INTERACTIONS AND DOSE RECOMMENDATIONS WITH OTHER MEDICINAL PRODUCTS Medicinal products by Interaction Geometric mean change Recommendations concerning co- therapeutic areas (%) administration HIV ANTIRETROVIRALS Integrase strand transfer inhibitors Dolutegravir dolutegravir AUC ↓ 22% dolutegravir Darunavir co-administered with low C24h ↓ 38% dolutegravir Cmax ↓ 11% dose ritonavir and dolutegravir can darunavir ↔* be used without dose adjustment. * Using cross-study comparisons to historical pharmacokinetic data Raltegravir Some clinical studies suggest At present the effect of raltegravir raltegravir may cause a modest on darunavir plasma concentrations decrease in darunavir plasma does not appear to be clinically concentrations. relevant. Darunavir co-administered with low dose ritonavir and raltegravir can be used without dose adjustments. Nucleo(s/t)ide reverse transcriptase inhibitors (NRTIs) Didanosine didanosine AUC ↓ 9% Darunavir co-administered with low 400 mg once daily didanosine Cmin ND dose ritonavir and didanosine can didanosine Cmax ↓ 16% be used without dose adjustments. darunavir AUC ↔ Didanosine is to be administered on darunavir Cmin ↔ an empty stomach, thus it should be darunavir Cmax ↔ administered 1 hour before or 2 hours after darunavir/ritonavir given with food. Tenofovir disoproxil tenofovir AUC ↑ 22% Monitoring of renal function may 245 mg once daily‡ tenofovir Cmin ↑ 37% be indicated when darunavir co- tenofovir Cmax ↑ 24% administered with low dose # darunavir AUC ↑ 21% ritonavir is given in combination # darunavir Cmin ↑ 24% with tenofovir disoproxil, # darunavir Cmax ↑ 16% particularly in patients with underlying systemic or renal (↑ tenofovir from effect on MDR-1 disease, or in patients taking transport in the renal tubules) nephrotoxic agents. Emtricitabine/tenofovir Tenofovir alafenamide ↔ The recommended dose of alafenamide Tenofovir ↑ emtricitabine/tenofovir alafenamide is 200/10 mg once daily when used with darunavir with low dose ritonavir. Abacavir Not studied. Based on the different Darunavir co-administered with low Emtricitabine elimination pathways of the other dose ritonavir can be used with Lamivudine NRTIs zidovudine, emtricitabine, these NRTIs without dose Stavudine stavudine, lamivudine, that are adjustment. Zidovudine primarily renally excreted, and abacavir for which metabolism is not mediated by CYP450, no interactions are expected for these medicinal compounds and darunavir co- administered 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): tenofovir (HOS-088083) tenofovir alafenamide (HOS-110476) stavudine (HOS-088080) dolutegravir (HOS-089992) tenofovir disoproxil (HOS-108843) lamivudine (HOS-085829) didanosine (HOS-085836) zidovudine (HOS-085837) raltegravir (HOS-086187) ritonavir (HOS-084521) abacavir (HOS-088077) emtricitabine (HOS-085840)