Safety

The safety and tolerability of INVEGA TRINZA® were established in a long-term maintenance trial1

 

The overall safety of INVEGA TRINZA® (paliperidone palmitate) was comparable to INVEGA SUSTENNA® (paliperidone palmitate)1

  • Percentage of patients who discontinued due to adverse reactions during the open-label phase of the trial was 5.1%1
  • During the double-blind phase, no INVEGA TRINZA®-treated patients and 1 placebo-treated patient discontinued due to an adverse reaction1

Safety

 

 

WEIGHT GAIN:

Weight gain has been reported with atypical antipsychotic use. Clinical monitoring of weight is recommended.1

The safety and tolerability of paliperidone have been established in multiple formulations across many clinical trials1-3

Additional safety information observed in the long-term maintenance trial1

EPS data observed1

  • In the double-blind (DB) phase, 8% of patients taking INVEGA TRINZA® (paliperidone palmitate) (DB, n=160) demonstrated EPS-related adverse reactions vs 3% of patients taking placebo (DB, n=145)
    – 4% of patients taking INVEGA TRINZA® demonstrated an adverse reaction of parkinsonism in the DB phase, while no potential symptoms of parkinsonism were noted in the placebo group
    – 1% of patients taking INVEGA TRINZA® demonstrated an adverse reaction of dystonia in the DB phase, while no potential symptoms of dystonia were noted in the placebo group
  • In the open-label phase (n=506), 10% of patients demonstrated EPS-related adverse reactions
    – 4% of patients in the open-label phase demonstrated an adverse reaction of parkinsonism, and 1% of patients experienced an adverse reaction of dystonia
    – During the open-label phase, subjects received several doses of INVEGA SUSTENNA® (paliperidone palmitate) followed by a single dose of INVEGA TRINZA®

References: 1. INVEGA TRINZA® [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc.; March 2016. 2. INVEGA SUSTENNA® [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc.; March 2016. 3. INVEGA® [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc.; March 2016.