SUMMARY  

• INVEGA TRINZA should be administered once every 3 months. Missing doses of INVEGA TRINZA should be avoided. If necessary, patients may be given the injection up to 2 weeks before or after the 3-month time point.¹
• There are no data from clinical trials to support the routine administration of INVEGA TRINZA maintenance doses at intervals shorter or longer than 3 months or to confirm the impact of alternate dosing intervals on clinical benefit and/or adverse events.
• Compared with the 12-week dosing interval of INVEGA TRINZA, pharmacokinetic simulations have shown that higher paliperidone concentrations are achieved with every 8-week dosing, while lower paliperidone concentrations result from every 16-week and 20-week dosing.²
• More frequent administration of INVEGA TRINZA (e.g., every 8 weeks, every 10 weeks) is not consistent with the product labeling and, is therefore, not recommended.

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 milligrams 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.

published and unpublished data

Pharmacokinetic Simulations

Extrapolated pharmacokinetic simulations were developed to predict paliperidone plasma concentrations if the dosing frequency of INVEGA TRINZA 819 mg and 410 mg was increased or decreased from the recommended 12-week frequency.²

In Figure: Pharmacokinetic Simulation of INVEGA TRINZA Every 8-, 12-, 16-, or 20-Week Dosing Interval, pharmacokinetic simulations present predicted paliperidone plasma levels of INVEGA TRINZA 819 mg administered every 8, 16, or 20 weeks compared with the recommended every-12-weeks administration. Higher paliperidone C_min and C_max levels are achieved with 8-week dosing compared with 12-week dosing of INVEGA TRINZA. Conversely, dosing every 16 and 20 weeks produces lower paliperidone C_min and C_max levels compared with 12-week dosing of INVEGA TRINZA. See Table: Comparison of C_max and C_min for INVEGA TRINZA 819 mg at Dosing Intervals of Every 8, 12, 16, or 20 Weeks. Please note, these results are based on pharmacokinetic simulations and no clinical studies have been performed to confirm the clinical benefit and/or impact on adverse events from alternate dosing intervals of INVEGA TRINZA.

Abbreviations: PP3M, paliperidone palmitate 3-month.

Similar results were obtained with INVEGA TRINZA 410 mg administered every 8, 16 or 20 weeks compared with the 12-week dosing interval, as displayed in Figure: Pharmacokinetic Simulation of INVEGA TRINZA 410 mg Every 8-, 12-, 16-, or 20-Week Dosing Interval. Compared with the 12-week dosing interval, INVEGA TRINZA 410 mg every 8 weeks produced higher paliperidone C_min and C_max levels, while dosing every 16 and 20 weeks produced lower paliperidone C_min and C_max levels. See Table: Comparison of C_max and C_min for INVEGA TRINZA 410 mg at Dosing Intervals of Every 8, 12, 16, or 20 Weeks. Please note, these results are based on pharmacokinetic simulations and no clinical studies have been performed to confirm the clinical benefit and/or impact on adverse events from alternate dosing intervals of INVEGA TRINZA.

Abbreviations: PP3M, paliperidone palmitate 3-month.

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 27 March 2024.