Weight Change Across Short-term and Long-term INVEGA SUSTENNA® Studies

Mean change in body weight from 4 placebo-controlled 9- to 13-week, fixed-dose studies1

weight change long term

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 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 Study Design

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

maintenance study

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 patients1,2

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

References: 1. INVEGA SUSTENNA® [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc.; January 2019. 2. Hough D, Gopal S, Vijapurkar U, Lim P, Morozova M, Eerdekens M. 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.