What should clinicians know about Invega Trinza (paliperidone palmitate 12-week LAI)?

Invega Trinza is a long-acting injectable (LAI) formulation of paliperidone. It is the first available antipsychotic LAI available that provides coverage for 12 weeks. It is FDA-indicated to treat adults with schizophrenia.

Invega Trinza

Indication(s)

Schizophrenia

Dosing available as prefilled syringes

273 mg (injection volume of 0.875 ml) 
410 mg (injection volume of 1.315 ml)
546 mg (injection volume of 1.75 ml)
819 mg (injection volume of 2.625 ml)

Recommended starting and maintenance dose

Used only after establishment of four months of Invega Sustenna once monthly injection (last 2 months with the same dose); dose based on Invega Sustenna IM once monthly dose

Drug Metabolizing Enzyme

CYP3A4

Dosing exclusions

Invega Trinza is not recommended in patients with moderate or severe renal impairment

Loading dose

Dose equivalence to Sustenna:
39 mg Invega Sustenna to N/A for Trinza
78 mg of Invega Sustenna to 273 mg for Trinza
117 mg Invega Sustenna to 410 mg Trinza
156 mg Sustenna to 546 mg Trinza
234 mg Sustenna to 819 Trinza

Oral overlap

None required.

Establishing tolerability

Prior to initiating Invega Trinza, treat the patient with Invega Sustenna (1 month formulation of paliperidone palmitate) for at least 4 months to ensure optimal dosing. In order to establish a consistent maintenance dose, it is recommended that the last two doses of Invega Sustenna be the same dosage strength before starting Invega Trinza.

Storage

Room temperature

Reconstitution or mixing

No reconstitution required
See Invega Sustenna for any changes

Injection site

Choose between the deltoid or gluteal muscle based on the patient preference and body habitus. Rotate injection sites to avoid muscle hypertrophy, abscesses, and tissue damage by repeated, frequent injections at the same site.

Injection interval

Every 12 weeks

Preparation

With the syringe tip pointing up, shake vigorously with a loose wrist for at least 15 seconds to ensure a homogeneous suspension. If more than 5 minutes pass before injection, shake vigorously, with the syringe tip pointing up, again for at least 15 second to re-suspend the medication. Priming the syringe is recommended.

Administration considerations

Inject the entire contents intramuscularly slowly, deep into the selected deltoid or gluteal muscle of the patient.
The thin-walled needles included in the Invega Trinza kit must be used for the injection.

Timing variations

To avoid a missing dose: patients may be given the injection up to 2 weeks before or after the 3-month time point.

When a dose is missed

If a patient has missed a dose and it is 3.5 months to 4 months since last injection: the previously administered Trinza dose should be administered as soon as possible, then continue with the 3-month injections following the dose.

If 4 months to 9 months since last injection: This requires re-initiation via table 2 in the package insert.

REMS

No

 

Dose Conversion of Oral Paliperidone to Paliperidone Palmitate 12-week LAI

PO Dose 

LAI/Invega Sustenna Dose **Stabilization with Invega Sustenna required prior to initiation of Invega Trinza

LAI/Invega Trinza Dose

< 3 mg paliperidone

39 mg Invega Sustenna every 4 weeks

N/A

3 mg paliperidone

78 mg Invega Sustenna every 4 weeks

273 mg Invega Trinza every 12 weeks

6 mg paliperidone

117 mg Invega Sustenna every 4 weeks

410 mg Invega Trinza every 12 weeks

9 mg paliperidone

156 mg Invega Sustenna every 4 weeks

546 mg Invega Trinza every 12 weeks

12 mg paliperidone

234 mg Invega Sustenna every 4 weeks

819 mg Invega Trinza every 12 weeks

Recommended available dose formulations include 273 mg, 410 mg, 546 mg, and 819 mg pre-filled syringes.

Dose reduction may be necessary for CYP450 interactions of side effect intolerance.

References:
1. Stahl, S. M. (2017). The prescriber’s guide: Stahl’s essential psychopharmacology (6th ed.). New York: Cambridge University Press.
2. American Psychiatric Association. (2020). The American Psychiatric Association Practice Guideline for the Treatment of Patients With Schizophrenia. American Psychiatric Association Publishing. https://doi.org/10.1176/appi.books.9780890424841
3. INVEGA SUSTENNA USPI, Section 2.8: Instructions for Use; Section 17: How Supplied/Storage and Handling 

FDA Medication Label

Information on this topic is found in the FDA medication label.  Not all information in the FDA medication label is included here, and clinicians should read the entire FDA medication label before making treatment decisions.

Prescribing should always be informed by the FDA medication label. Medication labels can be found by searching Drugs@FDA at the FDA website. Labels are also available using the Drugs@FDA app for Apple or Android devices.

Labels change over time, and the current label should always be consulted. Here is the most recent label, at time of writing.

Administration/Dosing Guide

More information about administration (including a detailed video) and dosing can be found here.

 

REFERENCES

  • INVEGA SUSTENNA USPI, Section 1: Indications and Usage
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