Wirkstoffe & Arzneimittelsicherheit

Wechselwirkungen · Harvoni

Harvoni 33.75 mg/150 mg coated granules in sachet Harvoni 45 mg/200 mg coated granules in sachet · Abschnitt 4.5 · PDF-Seite 52–53

HOS-132349 · Präparat HOS-097208

52 Medicinal product by Effects on medicinal Recommendation concerning co-administration therapeutic areas product levels. with Harvoni Mean ratio (90% confidence interval) for AUC, Cmax, Cmina, b Atazanavir boosted with Atazanavir When given with tenofovir disoproxil fumarate used ritonavir (300 mg/ 100 mg ↔ Cmax 1.07 (0.99, 1.14) in conjunction with atazanavir/ritonavir, Harvoni once daily) + emtricitabine/ ↔ AUC 1.27 (1.18, 1.37) increased the concentration of tenofovir. tenofovir disoproxil ↑ Cmin 1.63 (1.45, 1.84) fumarate (200 mg/ 300 mg The safety of tenofovir disoproxil fumarate in the once daily)/ ledipasvir Ritonavir setting of Harvoni and a pharmacokinetic enhancer (90 mg once daily)c/ ↔ Cmax 0.86 (0.79, 0.93) (e.g. ritonavir or cobicistat) has not been sofosbuvir (400 mg once ↔ AUC 0.97 (0.89, 1.05) established. daily)c, d ↑ Cmin 1.45 (1.27, 1.64) The combination should be used with caution with Dosed simultaneouslyf Emtricitabine frequent renal monitoring, if other alternatives are ↔ Cmax 0.98 (0.94, 1.02) not available (see section 4.4). ↔ AUC 1.00 (0.97, 1.04) ↔ Cmin 1.04 (0.96, 1.12) Atazanavir concentrations are also increased, with a risk for an increase in bilirubin levels/icterus. That Tenofovir risk is even higher if ribavirin is used as part of the ↑ Cmax 1.47 (1.37, 1.58) HCV treatment. ↔ AUC 1.35 (1.29, 1.42) ↑ Cmin 1.47 (1.38, 1.57)

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): tenofovir (HOS-088083) atazanavir (HOS-086180) cobicistat (HOS-088111) tenofovir disoproxil (HOS-108843) ribavirin (HOS-088127) fumarate (HOS-108845) tenofovir disoproxil fumarate (HOS-110471) ritonavir (HOS-084521) emtricitabine (HOS-085840)