Wirkstoffe & Arzneimittelsicherheit

Wechselwirkungen · Darunavir Viatris (previously Darunavir Mylan)

Darunavir Viatris 400 mg film-coated tablets Darunavir Viatris 800 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 52–53

HOS-134612 · Präparat HOS-097580

52 INTERACTIONS AND DOSE RECOMMENDATIONS WITH OTHER MEDICINAL PRODUCTS Medicinal products by Interaction Recommendations concerning co- therapeutic areas Geometric mean change (%) administration 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 co-administered with # darunavir Cmax ↔ cobicistat should not be used in combination with another Atazanavir: comparison of antiretroviral agent that requires atazanavir/ritonavir 300/100 mg pharmacoenhancement by means of once daily vs. atazanavir 300 mg co- administration with an inhibitor once daily in combination with of CYP3A4 (see section 4.5). darunavir/ritonavir 400/100 mg twice daily. Darunavir: comparison of darunavir/ritonavir 400/100 mg twice daily vs. darunavir/ritonavir 400/100 mg twice daily in combination with atazanavir 300 mg once daily. Indinavir indinavir AUC ↑ 23% When used in combination with 800 mg twice daily indinavir Cmin ↑ 125% darunavir co-administered with low indinavir Cmax ↔ dose ritonavir, dose adjustment of # darunavir AUC ↑ 24% indinavir from 800 mg twice daily to 600 mg twice daily may be warranted # darunavir Cmin ↑ 44% in case of intolerance. # darunavir Cmax ↑ 11% Darunavir co-administered with Indinavir: comparison of cobicistat should not be used in indinavir/ritonavir 800/100 mg combination with another twice daily vs. antiretroviral agent that requires indinavir/darunavir/ritonavir pharmacoenhancement by means of 800/400/100 mg twice daily. co- administration with an inhibitor Darunavir: comparison of of CYP3A4 (see section 4.5). darunavir/ritonavir 400/100 mg twice daily vs. darunavir/ritonavir 400/100 mg in combination with indinavir 800 mg twice daily. Saquinavir # darunavir AUC ↓ 26% It is not recommended to combine 1,000 mg twice daily # darunavir Cmin ↓ 42% darunavir co-administered with low # darunavir Cmax ↓ 17% dose ritonavir with saquinavir. saquinavir AUC ↓ 6% Darunavir co-administered with saquinavir Cmin ↓ 18% cobicistat should not be used in saquinavir Cmax ↓ 6% combination with another antiretroviral agent that requires Saquinavir: comparison of pharmacoenhancement by means of saquinavir/ritonavir 1,000/100 mg co- administration with an inhibitor twice daily vs. of CYP3A4 (see section 4.5). saquinavir/darunavir/ritonavir 1,000/400/100 mg twice daily Darunavir: comparison of darunavir/ritonavir 400/100 mg twice daily vs. darunavir/ritonavir 400/100 mg in combination with saquinavir 1,000 mg twice daily.

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): indinavir (HOS-084518) atazanavir (HOS-086180) protease (HOS-085623) cobicistat (HOS-088111) saquinavir (HOS-084522) ritonavir (HOS-084521)