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 10–11

HOS-134481 · Präparat HOS-097580

10 INTERACTIONS AND DOSE RECOMMENDATIONS WITH OTHER MEDICINAL PRODUCTS Medicinal products by Interaction Geometric mean change Recommendations concerning co- therapeutic areas (%) administration 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% darunavir co-administered with low # darunavir Cmax ↓ 15% dose ritonavir is given in combination with efavirenz. (↑ efavirenz from CYP3A inhibition) (↓ darunavir from CYP3A induction) Efavirenz in combination with darunavir/ritonavir 800/100 mg once daily may result in sub- optimal darunavir Cmin. If efavirenz is to be used in combination with darunavir/ritonavir, the darunavir/ritonavir 600/100 mg twice daily regimen should be used (see section 4.4). Etravirine etravirine AUC ↓ 37% Darunavir co-administered with low 100 mg twice daily etravirine Cmin ↓ 49% dose ritonavir and etravirine 200 mg etravirine Cmax ↓ 32% twice daily can be used without dose adjustments. darunavir AUC ↑ 15% darunavir Cmin ↔ darunavir Cmax ↔ Nevirapine nevirapine AUC ↑ 27% Darunavir co-administered with low 200 mg twice daily nevirapine Cmin ↑ 47% dose ritonavir and nevirapine can be nevirapine Cmax ↑ 18% used without dose adjustments. # darunavir: concentrations were consistent with historical data (↑ nevirapine from CYP3A inhibition) Rilpivirine rilpivirine AUC ↑ 130% Darunavir co-administered with low 150 mg once daily rilpivirine Cmin ↑ 178% dose ritonavir and rilpivirine can be rilpivirine C ↑ 79% used without dose adjustments. max darunavir AUC ↔ darunavir Cmin ↓ 11% darunavir Cmax ↔ HIV Protease inhibitors (PIs) - without additional co-administration of low dose ritonavir† Atazanavir atazanavir AUC ↔ Darunavir co-administered with low 300 mg once daily atazanavir Cmin ↑ 52% dose ritonavir and atazanavir can be atazanavir Cmax ↓ 11% used without dose adjustments. # darunavir AUC ↔ # darunavir Cmin ↔ # darunavir Cmax ↔

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): atazanavir (HOS-086180) protease (HOS-085623) etravirine (HOS-088088) rilpivirine (HOS-088090) efavirenz (HOS-087947) nevirapine (HOS-088064) ritonavir (HOS-084521)