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Adverse Reactions | INVEGA SUSTENNA® HCP
  1. Safety & Tolerability
  2. Adverse Reactions | INVEGA SUSTENNA® HCP

INVEGA SUSTENNA® Has Been Evaluated in Over 2500 Patients Across 7 Trials1-4

Adverse reactions occurring in ≥2% of patients in the long-term maintenance trial2*

adverse reactions
  • 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 disorder1

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.

Adverse Reactions in the 4 Short-term (9-week and 13-week) Studies1†

adverse reaction short term

†Occurring in 5% of patients treated with INVEGA SUSTENNA®.

‡Initial deltoid injection of 234-mg followed by either 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 gluteal injection.1

Treatment-Emergent Adverse Events (TEAEs) in ≥5% of Patients in Any INVEGA SUSTENNA® Group and at Least Twice That of the Oral Group in the Comparative Efficacy Study3

treatment emergent adverse event 1

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 (AEs) was 11.9% in the INVEGA SUSTENNA® group and 7.8% in the oral antipsychotic group3
  • The 5 most common AEs 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).

TEAEs in ≥5% of Patients in the Recently Diagnosed Study4

treatment emergent adverse event 2
  • 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 (AEs) 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%)
clinically-important-drug-interactions

CYP3A4=cytocrome P450 3A4; P-gp=P-glycoprotein.

References: 1. INVEGA SUSTENNA® [Prescribing Information]. Titusville, NJ: Janssen Pharmaceuticals, Inc.; July 2022. 2. Hough D, Gopal S, Vijapurkar U, et al. 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;169:393-399.