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INVEGA SUSTENNA®

(paliperidone palmitate)

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INVEGA SUSTENNA® (paliperidone palmitate)

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INVEGA SUSTENNA - Missed Doses - During Maintenance Therapy

Last updated : 11/11/2024

SPECIFIC RESPONSE

To avoid a missed monthly dose, patients may be given the paliperidone palmitate injection up to 7 days before or after the monthly time point.1 For a missed maintenance dose of INVEGA SUSTENNA, the re-initiation regimen should be determined by the duration of time since the previous dose of paliperidone palmitate.1, 2, 3

Management of Missed Maintenance Doses of INVEGA SUSTENNAa,1,2

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Timing of Missed Maintenance Dose

Dosing
4 to 6 weeks since last injection

Resume regular monthly dosing as soon as possible at the patient’s previously stabilized dose, followed by injections at monthly intervals.
>6 weeks to 6 months since last injection

Resume the same dose the patient was previously stabilized on (unless the patient was stabilized on a dose of 234 mg, then the first 2 injections should each be 156 mg) in the following manner:

  1. Administer a deltoid injection as soon as possible.

  2. Administer a second deltoid injection 1 week later at the same dose.

  3. Thereafter, resume administering the previously stabilized dose in the deltoid or gluteal muscle 1 month after the second injection.

>6 months since last injection

Restart dosing with recommended initiation:

  1. Administer a 234 mg deltoid injection on Day 1.

  2. Administer a 156 mg deltoid injection 1 week later.

  3. Thereafter, resume administering the previously stabilized dose in the deltoid or gluteal muscle 1 month after the second injection.

aThe PK simulation model was applied to scenarios where maintenance doses (given at once monthly intervals) were missed, and reinitiation was attempted with one or two doses of paliperidone palmitate. Recommendations were developed empirically to maintain steady-state concentrations of paliperidone.

Clinical Rationale

Samtani et al (2009)2 presented results from a population PK simulation model on the flexibility of dosing windows and the management of missed doses of paliperidone palmitate during initiation or maintenance treatment. The simulation model assessed PK exposure of paliperidone palmitate in patients with dosing variations during specific time windows.

PK, pharmacokinetic.

References

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1. INVEGA SUSTENNA [(paliperidone palmitate) Extended-Release Injectable Suspension] [Prescribing Information]. Titusville, NJ: Janssen Pharmaceuticals, Inc; https://imedicalknowledge.veevavault.com/ui/approved_viewer?token=7994-54c7ff1c-5e50-4845-a605-24e8c5104cd7.

2. Samtani MN, Gopal S, Sliwa JK, et al. Management of missed paliperidone palmitate doses based on pharmacokinetic modeling and simulation. Poster presented at: The New Clinical Drug Evaluation Unit; June 29 - July 2, 2009; Hollywood, FL. 2009.

3. Samtani MN, Gopal S, Gassmann-Mayer C. Dosing and switching strategies for paliperidone palmitate: based on population pharmacokinetic modelling and clinical trial data. CNS Drugs. 2011;25(10):829-845.