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 8–9

HOS-136139 · Präparat HOS-097846

8 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 ANTIARRHYTHMICS Amiodarone Effect on amiodarone, velpatasvir, and Co-administration of amiodarone sofosbuvir concentrations unknown. with a sofosbuvir containing regimen may result in serious symptomatic bradycardia. Use only if no other alternative is available. Close monitoring is recommended if this medicinal product is administered with Epclusa (see sections 4.4 and 4.8). Digoxin Interaction only studied with velpatasvir. Co-administration of Epclusa with Expected: digoxin may increase the ↔ Sofosbuvir concentration of digoxin. Caution Digoxin (0.25 mg single Effect on velpatasvir exposure not studied is warranted and therapeutic dose)f/ velpatasvir (100 mg Expected: concentration monitoring of single dose) ↔ Velpatasvir digoxin is recommended when co-administered with Epclusa. (Inhibition of P-gp) Observed: Digoxin ↑ ↑ 1.9 1.3 (1.7, (1.1, 2.1) 1.6) ANTICOAGULANTS Dabigatran etexilate Interaction not studied. Clinical monitoring, looking for Expected: signs of bleeding and anaemia, is ↑ Dabigatran recommended when dabigatran ↔ Sofosbuvir etexilate is co-administered with ↔ Velpatasvir Epclusa. A coagulation test helps (Inhibition of P-gp) to identify patients with an increased bleeding risk due to increased dabigatran exposure. Vitamin K antagonists Interaction not studied Close monitoring of INR is recommended with all vitamin K antagonists. This is due to liver function changes during treatment with Epclusa. ANTICONVULSANTS Phenytoin Interaction not studied. Epclusa is contraindicated with Phenobarbital Expected: phenobarbital and phenytoin (see ↓ Sofosbuvir section 4.3). (Induction of P-gp and ↓ Velpatasvir CYPs) Carbamazepine Interaction not studied. Epclusa is contraindicated with Expected: carbamazepine (see section 4.3). ↓ 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): phenobarbital (HOS-085617) carbamazepine (HOS-085618) vitamin K (HOS-091176) digoxin (HOS-086172) dabigatran (HOS-112096) amiodarone (HOS-085596) dabigatran etexilate (HOS-086233) phenytoin (HOS-084531)