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 13–14

HOS-136151 · Präparat HOS-097846

13 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 IMMUNOSUPPRESSANTS Ciclosporin Ciclosporin ↔ ↔ No dose adjustment of Epclusa or (600 mg single dose)/ ciclosporin is required at initiation sofosbuvir (400 mg single Sofosbuvir ↑ ↑ of co-administration. Afterwards, dose)f 2.5 4.5 close monitoring and potential (1.9, (3.3, dose adjustment of ciclosporin may 3.5) 6.3) be required. Ciclosporin Ciclosporin ↔ ↓ (600 mg single dose)f/ 0.88 velpatasvir (100 mg single (0.78, dose)d 1.0) Velpatasvir ↑ ↑ 1.6 2.0 (1.2, (1.5, 2.0) 2.7) Tacrolimus Tacrolimus ↓ ↑ No dose adjustment of Epclusa or (5 mg single dose)f/ 0.73 1.1 tacrolimus is required at initiation sofosbuvir (400 mg single (0.59, (0.84, of co-administration. Afterwards, dose)d 0.90) 1.4) close monitoring and potential Sofosbuvir ↓ ↑ dose adjustment of tacrolimus may 0.97 1.1 be required. (0.65, (0.81, 1.4) 1.6) Tacrolimus Effect on velpatasvir exposure not studied. Expected: ↔ Velpatasvir ORAL CONTRACEPTIVES Norgestimate/ ethinyl Norel- ↔ ↔ ↔ No dose adjustment of oral estradiol (norgestimate gestromin contraceptives is required. 0.180 mg/ 0.215 mg/ 0.25 mg/ ethinyl estradiol 0.025 mg)/ sofosbuvir (400 mg once daily)d Norgestrel ↔ ↑ ↑ 1.2 1.2 (0.98, (1.0, 1.5) 1.5) Ethinyl ↔ ↔ ↔ estradiol Norgestimate/ ethinyl Norel- ↔ ↔ ↔ estradiol (norgestimate gestromin 0.180 mg/ 0.215 mg/ Norgestrel ↔ ↔ ↔ 0.25 mg/ ethinyl estradiol 0.025 mg)/ velpatasvir Ethinyl ↑ ↔ ↓ (100 mg once daily)d estradiol 1.4 0.83 (1.2, (0.65, 1.7) 1.1) a Mean ratio (90% CI) of co-administered drug pharmacokinetics of study medicinal products alone or in combination. No effect = 1.00. b All interaction studies conducted in healthy volunteers. c Administered as Epclusa. d Lack of pharmacokinetics interaction bounds 70-143%. e These are medicinal products within class where similar interactions could be predicted. f Bioequivalence/Equivalence boundary 80-125%. g Lack of pharmacokinetics interaction bounds 50-200%.

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): norgestimate (HOS-110544) estradiol (HOS-090751) ethinyl estradiol (HOS-088135) tacrolimus (HOS-085202) norgestrel (HOS-090613)