Summary

• INVEGA TRINZA should be administered once every 3 months. Missing doses of INVEGA TRINZA should be avoided. Patients may be given the injection up to 2 weeks before or after the 3-month time point.¹
• In the long-term maintenance trial, patients were randomized to INVEGA TRINZA or placebo administered every 12 weeks in the double-blind phase.²
• Pharmacokinetic simulations were performed to compare every 12-week (Q12W) versus every 13-week (Q13W) dosing at steady state with INVEGA TRINZA and to demonstrate the impact of Q13W dosing on paliperidone levels. Simulations suggest that Q13W dosing has similar exposure as Q12W dosing.^1,3

DOSAGE STRENGTH INFORMATION

Doses of paliperidone palmitate extended-release injectable suspension may be expressed in milligram equivalents of paliperidone (active moiety) or milligrams of paliperidone palmitate. Dosage information in this response has been converted to mg of paliperidone palmitate to reflect the commercially available dosage strengths in the United States. The conversion factor from mg eq to mg is 1.56.

• INVEGA TRINZA doses expressed as 273, 410, 546 and 819 mg of paliperidone palmitate are equal to 175, 263, 350 and 525 mg eq of paliperidone, respectively.

ASSESSMENT OF DOSING EVERY 12 WEEKS VERSUS EVERY 13 WEEKS

Pharmacokinetic simulations were performed to compare the impact on paliperidone levels from Q12W vs Q13W dosing at steady state with 273 mg and 546 mg of INVEGA TRINZA. The predicted minimum concentrations (C_min) at the end of a Q12W vs Q13W dosing interval are presented in the Table: Median C_min After Q12W vs Q13W Administration of INVEGA TRINZA.^1,3

Simulations suggest that Q13W dosing has similar exposure as Q12W dosing (Figure: Plasma Concentration of INVEGA TRINZA Administered Q12W vs Q13W).

LITERATURE SEARCH

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, DERWENT Drug File (and/or other resources, including internal/external databases) pertaining to this topic was conducted on 02 April 2024.