Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Eviplera

Eviplera 200 mg/25 mg/245 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 22–23

HOS-214434 · Präparat HOS-155326

22 5 This adverse reaction may occur as a consequence of proximal renal tubulopathy. It is not considered to be causally associated with tenofovir disoproxil in the absence of this condition. 6 This was a rare adverse reaction for tenofovir disoproxil. It was also identified as an adverse reaction for emtricitabine through post-marketing surveillance but was not observed in randomised controlled clinical studies in adults or paediatric HIV clinical studies of emtricitabine. The frequency category of uncommon was estimated from a statistical calculation based on the total number of patients exposed to emtricitabine in these clinical studies (n = 1,563). 7 This adverse reaction was identified through post-marketing surveillance for Eviplera (fixed-dose combination) but not observed in randomised controlled clinical studies for Eviplera. The frequency category was estimated from a statistical calculation based on the total number of patients exposed to Eviplera or all of its components in randomised controlled clinical studies (n = 1,261). See section 4.8, Description of selected adverse reactions. 8 This adverse reaction was identified through post-marketing surveillance for tenofovir disoproxil but not observed in randomised controlled clinical studies or the expanded access program for tenofovir disoproxil. The frequency category was estimated from a statistical calculation based on the total number of patients exposed to tenofovir disoproxil in randomised controlled clinical studies and the expanded access program (n = 7,319).

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