SUMMARY  

• The maximum dose of INVEGA TRINZA injection is 819 mg every 3 months. Doses higher than INVEGA TRINZA 819 mg were not evaluated in the pivotal clinical trials.¹
• INVEGA TRINZA has not been systematically studied in patients with renal impairment.²
• For patients with mild renal impairment (creatinine clearance [CrCl] 50-80 mL/min [using Cockcroft-Gault Formula]), stabilize the patient using the 1-month paliperidone palmitate extended-release injectable suspension with a 25% dose reduction, then transition to INVEGA TRINZA. INVEGA TRINZA is not recommended in patients with moderate or severe renal impairment (CrCl <50 mL/min).³
• In a prospective, 1-year, observational study in patients with severe schizophrenia (Clinical Global Impression-Severity [CGI-S]≥5), a more frequent decrease in CGI-S scores was reported after 1 year of treatment in patients with greater disease severity at baseline; all were treated with higher doses of INVEGA TRINZA (>525 mg/3 months).^4,5

Clinical Data

Dose and Plasma Levels in an Observational Study of INVEGA TRINZA

Fernández-Miranda et al (2023 and 2024)^4,5 conducted a 1-year, prospective, observational study to evaluate the relationships between dose, plasma level (PL), and clinical outcomes to different doses of INVEGA TRINZA and 1-month aripiprazole for the treatment of patients with severe schizophrenia.

Study Design/Methods

• A total of 68 adult patients with severe schizophrenia (CGI-S≥5) and receiving stabilized doses of INVEGA TRINZA or 1-month aripiprazole for at least a year were included in the study.
• Patients were categorized into 2 dose-based groups: standard dose (licensed) (n=22; INVEGA TRINZA, ≤525 mg/3 months) and high dose (above licensed) (n=21; above standard dose).
• PLs were categorized into 2 ranges: recommended therapeutic range or standard range (INVEGA TRINZA 20-60 ng/mL) and high range (above standard range)
• The study evaluated the dose-PL relationship with treatment adherence, effectiveness, safety, and tolerability as well as blood biochemistry.

Results

• The patient population was 76.5% male, with a mean age of 48.1 years, and a baseline CGI-S score of 5.4.
• The dose-PL relationship was not completely linear.
  • Standard dose group: 54.5% (12/22) of patients achieved higher PLs (P<0.001), and 45.5% (10/22) achieved standard PLs.
  • High dose group: 90.5% (19/21) of patients achieved higher PLs, and 9.5% (2/21) achieved standard PLs.
• All patients continued treatment regardless of antipsychotic type, dose, or PL.
• Disease severity decreased (measured by CGI-S score at 1 year) more frequently for patients with greater severity at baseline; however, these patients were also treated with higher doses.
• Hospital admissions primarily decreased in patients with high PLs.
• None of the reported adverse effects were serious or led to a change in treatment.
• Adverse effects were generally not proportional to PLs, except parkinsonism with high doses of INVEGA TRINZA.
• The most common changes in blood biochemistry were elevations in lipids and prolactin levels, and elevations in prolactin were significantly related to high PLs of INVEGA TRINZA.

Literature Search

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File (and/or other resources, including internal/external databases) pertaining to this topic was conducted on 24 February 2025.