Wirkstoffe & Arzneimittelsicherheit

Wechselwirkungen · Epclusa

Epclusa 400 mg/100 mg film-coated tablets Epclusa 200 mg/50 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 12–13

HOS-136150 · Präparat HOS-097846

12 Medicinal product by Effects on medicinal product levels. therapeutic areas/Possible Mean ratio (90% confidence interval)a,b Recommendation concerning Mechanism of Interaction Active Cmax AUC Cmin co-administration with Epclusa HMG-CoA REDUCTASE INHIBITORS Atorvastatin (40 mg single Observed: ↑ ↑ No dose adjustment of Epclusa or dose) + sofosbuvir / Atorvastatin 1.7 1.5 atorvastatin is required. velpatasvir (400/ 100 mg (1.5, (1.5, once daily)d 1.9) 1.6) Rosuvastatin Interaction only studied with velpatasvir Co-administration of Epclusa with Expected: rosuvastatin increases the ↔ Sofosbuvir concentration of rosuvastatin, Rosuvastatin (10 mg single Observed: which is associated with increased dose)/ velpatasvir (100 mg Rosuvastatin ↑ ↑ risk of myopathy, including once daily)d 2.6 2.7 rhabdomyolysis. Rosuvastatin, at a (2.3, (2.5, dose that does not exceed 10 mg, 2.9) 2.9) may be administered with Epclusa. Effect on velpatasvir exposure not studied (Inhibition of OATP1B and Expected: BCRP) ↔ Velpatasvir Pravastatin Interaction only studied with velpatasvir No dose adjustment of Epclusa or Expected: pravastatin is required. ↔ Sofosbuvir Pravastatin (40 mg single Observed: dose)/ velpatasvir (100 mg Pravastatin ↑ ↑ once daily)d 1.3 1.4 (1.1, (1.2, 1.5) 1.5) (Inhibition of OATP1B) Effect on velpatasvir exposure not studied Expected: ↔ Velpatasvir Other statins Expected: Interactions cannot be excluded ↑ Statins with other HMG-CoA reductase inhibitors. When co-administered with Epclusa, careful monitoring for statin adverse reactions should be undertaken and a reduced dose of statins should be considered if required. NARCOTIC ANALGESICS Methadone R-methadone ↔ ↔ ↔ No dose adjustment of Epclusa or (Methadone maintenance methadone is required. therapy [30 to 130 mg S-methadone ↔ ↔ ↔ daily])/ sofosbuvir (400 mg once daily)d Sofosbuvir ↔ ↑ 1.3 (1.0, 1.7) Methadone Interaction only studied with sofosbuvir Expected: ↔ Velpatasvir

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): methadone (HOS-086198) atorvastatin (HOS-086304) rosuvastatin (HOS-086307) pravastatin (HOS-086306)