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Mean change in body weight from 4 placebo-controlled, 9- to 13-week, fixed-dose studies1
Significant weight gain has been reported with the use of INVEGA SUSTENNA®.
Clinical monitoring of weight gain is recommended.1
Weight gain ≥7% of total body weight was reported in 3.3% of placebo-treated patients compared with 6.0% (39 mg), 8.9% (78 mg), 9.0% (156 mg), 5.8% (234 mg/39 mg*), 8.3% (234 mg/156 mg*), and 13.1% (234 mg/234 mg*) of patients treated with INVEGA SUSTENNA®.
*Initial deltoid injection of 234 mg followed by 39 mg, 156 mg, or 234 mg every 4 weeks by deltoid or gluteal injection.
Other dose groups (39 mg, 78 mg, and 156 mg) are from studies involving only gluteal injection.1
Short-term (9-week and 13-week) study designs
Results from 4 placebo-controlled (one 9-week and three 13-week), fixed-dose studies of adult patients experiencing an acute exacerbation of schizophrenia.1
Mean change in body weight from the long-term maintenance study2
Significant weight gain has been reported with the use of INVEGA SUSTENNA®.
Clinical monitoring of weight gain is recommended.1
From the double-blind baseline to the endpoint of the longer-term maintenance study, 6% of patients treated with INVEGA SUSTENNA® had weight gain ≥7% of total body weight vs 3% of placebo-treated patients.1,2
Median exposure was 171 days.1
*Transition baseline to double-blind endpoint.2
Long-term study design
Results from the longer-term, placebo-controlled study of adult patients with schizophrenia. Patients were treated for 33 weeks during an open-label stabilization phase with INVEGA SUSTENNA® (39 mg, 78 mg, or 156 mg every 4 weeks after initiation). Patients were then randomized to this same dose or to placebo in a variable-length, double-blind phase. A preplanned interim analysis was conducted after 68 relapse events.1,2
References: 1. INVEGA SUSTENNA® [Prescribing Information]. Titusville, NJ: Janssen Pharmaceuticals, Inc. 2. Hough D, Gopal S, Vijapurkar U, et al. Paliperidone palmitate maintenance treatment in delaying the time-to-relapse in patients with schizophrenia: a randomized, double-blind, placebo-controlled study. Schizophr Res. 2010;116(2-3):107-117.