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 60–61

HOS-134628 · Präparat HOS-097580

60 INTERACTIONS AND DOSE RECOMMENDATIONS WITH OTHER MEDICINAL PRODUCTS Medicinal products by Interaction Recommendations concerning co- therapeutic areas Geometric mean change (%) administration ENDOTHELIN RECEPTOR ANTAGONISTS Bosentan Not studied. Concomitant use of When administered concomitantly bosentan and boosted darunavir with darunavir and low dose may increase plasma concentrations ritonavir, the patient's tolerability of of bosentan. bosentan should be monitored. Bosentan is expected to decrease plasma concentrations of darunavir Co-administration of darunavir co- and/or its pharmacoenhancer. administered with cobicistat and (CYP3A induction) bosentan is not recommended. HEPATITIS C VIRUS (HCV) DIRECT-ACTING ANTIVIRALS NS3-4A protease inhibitors Elbasvir/grazoprevir Boosted darunavir may increase the Concomitant use of boosted exposure to grazoprevir. darunavir and elbasvir/grazoprevir is (CYP3A and OATP1B inhibition). contraindicated (see section 4.3). Glecaprevir/pibrentasvir Based on theoretical considerations It is not recommended to co- boosted darunavir may increase the administer boosted darunavir with exposure to glecaprevir and glecaprevir/pibrentasvir. pibrentasvir. (P-gp, BCRP and/or OATP1B1/3 inhibition) HERBAL PRODUCTS St John's wort Not studied. St John's wort is Boosted darunavir must not be used (Hypericum perforatum) expected to decrease the plasma concomitantly with products concentrations of darunavir or its containing St John's wort (Hypericum pharmacoenhancers. perforatum) (see section 4.3). If a (CYP450 induction) patient is already taking St John's wort, stop St John's wort and if possible check viral levels. Darunavir exposure (and also ritonavir exposure) may increase on stopping St John's wort. The inducing effect may persist for at least 2 weeks after cessation of treatment with St John's wort. HMG CO-A REDUCTASE INHIBITORS Lovastatin Not studied. Lovastatin and Increased plasma concentrations of Simvastatin simvastatin are expected to have lovastatin or simvastatin may cause markedly increased plasma myopathy, including rhabdomyolysis. concentrations when co- Concomitant use of boosted administered with boosted darunavir with lovastatin and darunavir. simvastatin is therefore (CYP3A inhibition) contraindicated (see section 4.3). Atorvastatin atorvastatin AUC ↑ 3-4 fold When administration of atorvastatin 10 mg once daily atorvastatin Cmin ↑ ≈5.5-10 fold and boosted darunavir is desired, it is atorvastatin Cmax ↑ ≈2 fold recommended to start with an # darunavir/ritonavir atorvastatin dose of 10 mg once daily. A gradual dose increase of atorvastatin AUC ↑ 290% Ω atorvastatin may be tailored to the atorvastatin Cmax ↑ 319% Ω clinical response. atorvastatin Cmin ND Ω Ω with darunavir/cobicistat 800/150 mg

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): elbasvir (HOS-108814) protease (HOS-085623) lovastatin (HOS-086157) atorvastatin (HOS-086304) pibrentasvir (HOS-086298) cobicistat (HOS-088111) simvastatin (HOS-086158) glecaprevir (HOS-086297) hepatitis C virus (HOS-108813) grazoprevir (HOS-108815) ritonavir (HOS-084521) bosentan (HOS-086291)