Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Abilify Maintena

Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection in pre- filled syringe Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection in pre- filled syringe · Abschnitt 4.8 · PDF-Seite 13

HOS-129438 · Präparat HOS-096717

Weight During the double-blind, active-controlled phase of the 38-week long-term trial (see section 5.1), the incidence of weight gain of  7 % from baseline to last visit was 9.5 % for Abilify Maintena 400 mg/300 mg and 11.7 % for the oral aripiprazole tablets 10 mg to 30 mg. The incidence of weight loss of ≥ 7 % from baseline to last visit was 10.2 % for Abilify Maintena 400 mg/300 mg and 4.5 % for oral aripiprazole tablets 10 mg to 30 mg. During the double-blind, placebo-controlled phase of the 52-week long-term trial (see section 5.1), the incidence of weight gain of  7 % from baseline to last visit was 6.4 % for Abilify Maintena 400 mg/300 mg and 5.2 % for placebo. The incidence of weight loss of ≥ 7 % from baseline to last visit was 6.4 % for Abilify Maintena 400 mg/300 mg and 6.7 % for placebo. During double-blind treatment, mean change in body weight from baseline to last visit was −0.2 kg for Abilify Maintena 400 mg/300 mg and −0.4 kg for placebo (p = 0.812).

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