FOR US HEALTHCARE PROFESSIONALS ONLY
| Open-Label Phase Occurring in ≥5% | Double-Blind Phase* Occurring in ≥2% Treated With INVEGA TRINZA® | ||
|---|---|---|---|
| Paliperidone Palmitate† (n=506) | Placebo (n=145) | INVEGA TRINZA® (n=160) | |
| Upper respiratory tract infection | 5% | 4% | 10% |
| Headache | 7% | 4% | 9% |
| Weight increased | 10% | 3% | 9% |
| Akathisia | 5% | 2% | 5% |
| Parkinsonism | 5% | 0% | 4% |
| Injection-site reaction | 12% | 0% | 3% |
Occurring in at least 2% in the INVEGA TRINZA® group and at least twice the incidence occurring in the placebo group.1
During the open-label phase, subjects received several doses of INVEGA SUSTENNA® followed by a single dose of INVEGA TRINZA®.1
WEIGHT GAIN: Significant weight gain has been reported with atypical antipsychotic use. Clinical monitoring of weight is recommended.1
Other Adverse Reactions Identified in the long-term maintenance trial1
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
| Open-Label Phase | Double-Blind Phase | ||
|---|---|---|---|
| INVEGA SUSTENNA® ITT† (n=1429) | INVEGA SUSTENNA® (n=512) | INVEGA TRINZA® (n=504) | |
| Weight increased | 4% | 21% | 21% |
| Nasopharyngitis | 5% | 6% | 7% |
| Anxiety | 6% | 5% | 5% |
| Akathisia | 6% | 3% | 4% |
| Headache | 3% | 5% | 4% |
| Insomnia | 7% | 5% | 3% |
| Injection-site reaction | 9% | 3% | 2% |
At least 5% in the open-label phase or in the double-blind INVEGA SUSTENNA® or INVEGA TRINZA® treatment groups.
ITT=intent-to-treat population, which included all patients enrolled in the open-label phase.
| Concomitant drug name or 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 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. 2. INVEGA SUSTENNA® [Prescribing Information]. Titusville, NJ: Janssen Pharmaceuticals, Inc. 3. INVEGA® [Prescribing Information]. Titusville, NJ: Janssen Pharmaceuticals, Inc. 4. Savitz AJ, Xu H, Gopal S, et al. Efficacy and safety of paliperidone palmitate 3-month formulation for patients with schizophrenia: a randomized, multicenter, double-blind, noninferiority study. Int J Neuropsychopharm. 2016;19(7):1-14.
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