Summary

• INVEGA TRINZA is indicated for the treatment of schizophrenia in patients after they have been adequately treated with INVEGA SUSTENNA (1-month paliperidone palmitate extended-release injectable suspension) for at least four months.¹
• Safety data involving concomitant use of other antipsychotics with INVEGA TRINZA is limited.
• Extrapolated pharmacokinetic (PK) simulations were conducted to examine the paliperidone plasma levels achieved with a one-time addition of a INVEGA SUSTENNA injection to INVEGA TRINZA injections. By visual inspection of the data, administering one dose of INVEGA SUSTENNA 78, 117, or 156 mg (in the opposite gluteal or deltoid muscle with respect to the INVEGA TRINZA injection site) 4 weeks before the next INVEGA TRINZA dose to an individual receiving INVEGA TRINZA 410 mg or 546 mg (in the deltoid or gluteal muscle) appeared to lessen the fluctuation in paliperidone plasma levels achieved over the dosing interval, with somewhat higher maximum concentrations especially with the INVEGA SUSTENNA 156 mg dose. Importantly, these simulations represent extrapolations of a PK model, and have not been investigated in clinical trials.²
• Concomitant administration of INVEGA TRINZA and INVEGA SUSTENNA is not consistent with the local labeling.
• Caution should be exercised when INVEGA TRINZA is co-administered with INVEGA SUSTENNA due to additive levels of the same active compound.

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 SUSTENNA doses expressed as 39, 78, 117, 156, and 234 mg of paliperidone palmitate are equal to 25, 50, 75, 100, and 150 mg eq of paliperidone, respectively.
• 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.

PK MODELING

Extrapolated PK simulations were conducted to examine the paliperidone plasma levels achieved with a one-time addition of a INVEGA SUSTENNA injection to INVEGA TRINZA injections (see Figure: Comparison of INVEGA TRINZA 410 mg [Deltoid and Gluteal] Every 12 Weeks with INVEGA TRINZA 410 mg [Deltoid  and Gluteal] Every 12 Weeks + INVEGA SUSTENNA 78 mg, 117 mg, and 156 mg [Opposite Deltoid or Opposite Gluteal Muscle] Started 4 Weeks Before Next INVEGA TRINZA Dose and Figure: Comparison of INVEGA TRINZA 546 mg [Deltoid and Gluteal] Every 12 Weeks with INVEGA TRINZA 546 mg [Deltoid and Gluteal] Every 12 Weeks + INVEGA SUSTENNA 78 mg, 117 mg, and 156 mg [Opposite Deltoid or Opposite Gluteal Muscle] Started 4 Weeks Before Next INVEGA TRINZA Dose.²

By visual inspection of the data, administering one dose of INVEGA SUSTENNA 78, 117, or 156 mg (in the opposite gluteal or deltoid muscle with respect to the INVEGA TRINZA injection site) four weeks before the next INVEGA TRINZA dose to an individual receiving INVEGA TRINZA 410 mg or 546 mg (in the deltoid or gluteal muscle) appeared to lessen the fluctuation in paliperidone plasma levels achieved over the dosing interval, with somewhat higher maximum concentrations especially with the INVEGA SUSTENNA 156 mg dose (see Table: Comparison of C_min and C_max for INVEGA TRINZA 410 mg [Deltoid and Gluteal] Every 12 Weeks and INVEGA TRINZA 410 mg [Deltoid and Gluteal] Every 12 Weeks + INVEGA SUSTENNA 78 mg, 117 mg, and 156 mg [Opposite Deltoid or Opposite Gluteal Muscle] Started 4 Weeks Before Next INVEGA TRINZA Dose and Table: Comparison of C_min and C_max for INVEGA TRINZA 546 mg [Deltoid and Gluteal] Every 12 Weeks and INVEGA TRINZA 546 mg [Deltoid and Gluteal] Every 12 Weeks + INVEGA SUSTENNA 78 mg, 117 mg, and 156 mg [Opposite Deltoid or Opposite Gluteal Muscle] Started 4 Weeks Before Next INVEGA TRINZA Dose.²

Importantly, these simulations represent extrapolations of a PK model, and have not been investigated in clinical trials. Concomitant administration of INVEGA TRINZA and INVEGA SUSTENNA is not consistent with the local labeling for either product, and is therefore, not recommended.

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 07 January 2025.