Safety and Tolerability of INVEGA TRINZA®
The overall safety of INVEGA TRINZA® is comparable to INVEGA SUSTENNA® (paliperidone palmitate)1
in the clinical study1*
*At least 5% in INVEGA TRINZA® group during the open-label phase, or at least 2% in the INVEGA TRINZA® group during the double-blind phase and which occurred at a greater incidence than in the placebo group.
†During the open-label phase, patients received several doses of INVEGA SUSTENNA® followed by a single dose of INVEGA TRINZA®.
- The safety and tolerability of INVEGA TRINZA® were established in a long-term maintenance trial1
- The safety and tolerability of paliperidone have been established in multiple formulations across many clinical trials1-3
WEIGHT GAIN:Significant weight gain has been reported with atypical antipsychotic use. Clinical monitoring of weight is recommended.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
Other adverse reactions identified in the long-term maintenance trial1
- Cardiac disorders: tachycardia
- Gastrointestinal disorders: nausea, vomiting
- Metabolism and nutrition disorders: hyperinsulinemia
- Psychiatric disorders: anxiety
The risk of developing tardive dyskinesia (TD) appears to increase with duration of treatment and total cumulative dose but can develop after relatively brief treatment at low doses. Elderly female patients appeared to be at an increased risk for TD. If signs and symptoms of TD appear in a patient treated with INVEGA TRINZA®, drug discontinuation should be considered.1
Please see additional Important Safety Information.
Clinically Important Drug Interactions1
|Concomitant Drug Name or Drug Class||Clinical Rationale||Clinical Recommendation|
|Drugs with potential for inducing orthostatic hypotension||Because INVEGA TRINZA® has the potential for inducing orthostatic hypotension, an additive effect may occur when INVEGA TRINZA® is administered with other therapeutic agents that have this potential.||Monitor orthostatic vital signs in patients who are vulnerable to hypotension.|
|Strong inducers of CYP3A4 and P-gp (eg, carbamazepine, rifampin, or St. John’s wort)||The concomitant use of paliperidone and strong inducers of CYP3A4 and P-gp may decrease the exposure of paliperidone.||Avoid using CYP3A4 and/or P-gp inducers with INVEGA TRINZA® during the 3-month dosing interval, if possible. If administering a strong inducer is necessary, consider managing the patient using paliperidone extended-release tablets.|
|Levodopa and other dopamine agonists||Paliperidone may antagonize the effect of levodopa and other dopamine agonists.||Monitor and manage patient as clinically appropriate.|
CYP3A4=cytochrome P450 3A4; P-gp=P-glycoprotein.
References: 1. INVEGA TRINZA® [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc.; February 2017. 2. INVEGA SUSTENNA® [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc.; June 2017. 3. INVEGA® [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc.; February 2017.