FOR US HEALTHCARE PROFESSIONALS ONLY
INVEGA SUSTENNA® was evaluated in over 2,500 patients across 7 trials1-4
LONG-TERM PIVOTAL STUDY
Adverse reactions occurring in ≥2% of patients in the long-term maintenance trial2*
| Placebo (n=203) | INVEGA SUSTENNA® (n=205) | |
|---|---|---|
| Weight increase | 1% | 7% |
| Nasopharyngitis | 3% | 4% |
| Headache | 3% | 3% |
| Blood glucose increase | 1% | 3% |
| Gastroenteritis viral | <1% | 2% |
| Tremor | <1% | 2% |
In the 5 pivotal schizophrenia trials for INVEGA SUSTENNA®, the most common adverse reactions (incidence ≥5% and occurring at least twice as often as placebo) were injection-site reactions, somnolence/sedation, dizziness, akathisia, and extrapyramidal disorder.1
TARDIVE DYSKINESIA: The risk of developing tardive dyskinesia (TD) appears to increase with the 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 SUSTENNA®, drug discontinuation should be considered.1
*Occurring in ≥2% of INVEGA SUSTENNA® patients and more frequently than placebo-treated patients during the double-blind phase.2
SHORT-TERM PIVOTAL STUDY
Adverse reactions in the 4 short-term studies (9-week and 13-week)1*
| Placebo (n=510) | INVEGA SUSTENNA® | ||||||
|---|---|---|---|---|---|---|---|
| 39 mg (n=130) | 78 mg (n=302) | 156 mg (n=312) | 234/39 mg† (n=160) | 234/156 mg† (n=165) | 234/234 mg† (n=163) | ||
| Agitation | 7% | 10% | 5% | 9% | 8% | 5% | 4% |
| Anxiety | 7% | 8% | 5% | 3% | 5% | 6% | 6% |
| Vomiting | 4% | 5% | 4% | 2% | 3% | 2% | 2% |
| Akathisia | 3% | 2% | 2% | 3% | 1% | 5% | 6% |
| Somnolence/ sedation | 3% | 5% | 1% | 4% | 1% | 5% | 5% |
| Injection-site reaction | 2% | 0% | 4% | 6% | 9% | 7% | 10% |
| Dizziness | 12% | 11% | 11% | 15% | 11% | 7% | 6% |
| Headache | 1% | 6% | 2% | 4% | 1% | 4% | 2% |
| Extrapyramidal disorder | 1% | 5% | 2% | 3% | 1% | 0% | 0% |
IN THE COMPARATIVE EFFICACY STUDY
Treatment-emergent adverse events in ≥5% of patients in any INVEGA SUSTENNA® group and at least twice that of the oral group3
| TEAE, n (%) | INVEGA SUSTENNA® (n=226) | Oral Antipsychotics (n=218) |
|---|---|---|
| Injection-site pain | 42 (18.6%) | 0 |
| Weight increase | 27 (11.9%) | 13 (6.0%) |
| Fatigue | 17 (7.5%) | 6 (2.8%) |
| Erectile dysfunction | 17 (7.5%) | 0 |
| Libido decrease | 13 (5.8%) | 3 (1.4%) |
The safety of INVEGA SUSTENNA® was similar to that seen in previous schizophrenia double-blind, placebo-controlled trials1
- Percentage of patients who discontinued due to adverse events was 11.9% in the INVEGA SUSTENNA® group and 7.8% in the oral antipsychotic group3
- The 5 most common adverse events in the INVEGA SUSTENNA® group were injection-site pain (18.6%), insomnia (16.8%), weight increase (11.9%), akathisia (11.1%), and anxiety (10.6%)3
Data from randomization until end of randomly assigned treatment (28 days after last injection of INVEGA SUSTENNA® or 1 day after last dose of oral antipsychotic).3
TEAE=Treatment-emergent adverse event.
IN THE RECENTLY DIAGNOSED STUDY
Treatment-emergent adverse events in ≥5% of patients4
| TEAE, n (%) | INVEGA SUSTENNA® (n=352) | Oral Antipsychotics (n=363) |
|---|---|---|
| Increase in weight | 56 (15.9%) | 63 (17.4%) |
| Headache | 39 (11.1%) | 31 (8.5%) |
| Insomnia | 34 (9.7%) | 29 (8.0%) |
| Schizophrenia | 29 (8.2%) | 35 (9.6%) |
| Nasopharyngitis | 25 (7.1%) | 18 (5.0%) |
| Injection-site pain | 24 (6.8%) | 0 (0.0%) |
| Anxiety | 20 (5.7%) | 16 (4.4%) |
| Tremor | 18 (5.1%) | 8 (2.2%) |
| Suicidal ideation | 16 (4.5%) | 20 (5.5%) |
- The study was not powered to compare the efficacy of INVEGA SUSTENNA® with that of individual oral antipsychotics
- Percentage of patients who discontinued due to adverse events was 4.0% in the INVEGA SUSTENNA® group and 3.0% in the oral antipsychotic group
- The 5 most common treatment-emergent adverse events in INVEGA SUSTENNA® group were weight increase (15.9%), headache (11.1%), insomnia (9.7%), schizophrenia (8.2%), and nasopharyngitis (7.1%)
- The 5 most common treatment-emergent adverse events in the oral antipsychotic group were weight increase (17.4%), schizophrenia (9.6%), headache (8.5%), insomnia (8.0%), and suicidal ideation (5.5%)
TEAE=Treatment-emergent adverse event.
Clinically important drug interactions with INVEGA SUSTENNA®
Centrally acting drugs and alcohol1
Clinical Recommendation
INVEGA SUSTENNA® should be used with caution in combination with other centrally acting drugs and alcohol
Clinical Rationale
Given the primary CNS effects of paliperidone, concomitant use of centrally acting drugs and alcohol may modulate the CNS effects of INVEGA SUSTENNA®
Please see section 7.1 of the full Prescribing Information 
for more information.
Drugs with potential for inducing orthostatic hypotension1
Clinical Recommendation
Monitor orthostatic vital signs in patients who are vulnerable to hypotension
Clinical Rationale
Because INVEGA SUSTENNA® has the potential for inducing orthostatic hypotension, an additive effect may occur when INVEGA SUSTENNA® is administered with other therapeutic agents that have this potential
Please see section 7.1 of the full Prescribing Information for more information.
Strong inducers of CYP3A4 and P-gp (eg, carbamazepine, rifampin, or St. John’s Wort)1
Clinical Recommendation
Avoid using CYP3A4 and/ or P-gp inducers with INVEGA SUSTENNA® during the 1-month dosing interval, if possible. If administering a strong inducer is necessary, consider managing the patient using paliperidone extended-release tablets
Clinical Rationale
The concomitant use of paliperidone and strong inducers of CYP3A4 and P-gp may decrease the exposure of paliperidone
Please see section 7.1 of the full Prescribing Information for more information.
Levodopa and other dopamine agonists1
Clinical Recommendation
Monitor and manage patient as clinically appropriate
Clinical Rationale
Paliperidone may antagonize the effect of levodopa and other dopamine agonist
Please see section 7.1 of the full Prescribing Information for more information.
CNS=central nervous system; CYP3A4=cytocrome P450 3A4; P-gp=P-glycoprotein.
References: 1. INVEGA SUSTENNA® [Prescribing Information]. Titusville, NJ: Janssen Pharmaceuticals, Inc. 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. 3. Alphs L, Benson C, Cheshire-Kinney K, et al. Real-world outcomes of paliperidone palmitate compared to daily oral antipsychotic therapy in schizophrenia: a randomized, open-label, review board-blinded 15-month study. J Clin Psychiatry. 2015;76(5):554-561. 4. Schreiner A, Aadamsoo K, Altamura AC, et al. Paliperidone palmitate versus oral antipsychotics in recently diagnosed schizophrenia. Schizophr Res. 2015;169(1-3):393-399.