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 18–19

HOS-134512 · Präparat HOS-097580

18 INTERACTIONS AND DOSE RECOMMENDATIONS WITH OTHER MEDICINAL PRODUCTS Medicinal products by Interaction Geometric mean change Recommendations concerning co- therapeutic areas (%) administration ENDOTHELIN RECEPTOR ANTAGONISTS Bosentan Not studied. Concomitant use of When administered concomitantly bosentan and darunavir co- with darunavir and low dose administered with low dose ritonavir ritonavir, the patient’s tolerability of may increase plasma concentrations of bosentan should be monitored. bosentan. Bosentan is expected to decrease plasma concentrations of darunavir and/or its pharmacoenhancer. (CYP3A induction) HEPATITIS C VIRUS (HCV) DIRECT-ACTING ANTIVIRALS NS3-4A protease inhibitors Elbasvir/grazoprevir Darunavir with low dose ritonavir may Concomitant use of darunavir with increase the exposure to grazoprevir. low dose ritonavir and (CYP3A and OATP1B inhibition). elbasvir/grazoprevir is 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 expected Darunavir co-administered with low (Hypericum perforatum) to decrease the plasma concentrations dose ritonavir must not be used of darunavir and ritonavir. concomitantly with products (CYP450 induction) containing St John’s wort (Hypericum perforatum) (see section 4.3). If a 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 simvastatin Increased plasma concentrations of Simvastatin are expected to have markedly lovastatin or simvastatin may cause increased plasma concentrations when myopathy, including co-administered with darunavir co- rhabdomyolysis. Concomitant use administered with low dose ritonavir. of darunavir co-administered with (CYP3A inhibition) low dose ritonavir with lovastatin and simvastatin is therefore 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 darunavir co- administered with atorvastatin Cmax ↑ ≈2 fold low dose ritonavir is desired, it is # darunavir/ritonavir recommended to start with an atorvastatin dose of 10 mg once daily. A gradual dose increase of atorvastatin may be tailored to the clinical response.

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) simvastatin (HOS-086158) glecaprevir (HOS-086297) hepatitis C virus (HOS-108813) grazoprevir (HOS-108815) ritonavir (HOS-084521) bosentan (HOS-086291)