Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Rxulti

RXULTI 0.25 mg film-coated tablets RXULTI 0.5 mg film-coated tablets RXULTI 1 mg film-coated tablets RXULTI 2 mg film-coated tablets RXULTI 3 mg film-coated tablets RXULTI 4 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 12–13

HOS-132081 · Präparat HOS-097184

12 Weight gain In a short-term, controlled trial the percentage of subjects with clinically significant weight gain (increase of ≥ 7 % from baseline in body weight) was 8.2 % in brexpiprazole treated group, compared with 4.9 % in placebo group. The mean increase in weight from baseline to last visit was 0.8 kg in brexpiprazole and 0.0 kg in placebo-treated subjects. To adjust for normal growth, z-scores were derived (measured in standard deviations [SD]), which normalize for natural growth of children and adolescents by comparisons to age- and gender- matched population standards. A z-score change <0.5 SD is considered not clinically significant. In this study, no change in mean z-score from baseline to last visit was observed in brexpiprazole and placebo-treated groups. 4.5 % of subjects in brexpiprazole and 3.9 % subjects in placebo had an increase in age-and-gender-adjusted body weight z-score of at least 0.5 SD from baseline. TEAEs of weight gain was reported in 1.7% of all patients in the brexpiprazole group compared to 3.4% in placebo group. See section 4.4.

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