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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 Treatment Initiation

Last updated : 11/11/2024

SPECIFIC RESPONSE

To avoid a missed dose, patients may be given the second initiation dose 4 days before or after the one-week time point.1 For a missed second initiation dose of INVEGA SUSTENNA, the re-initiation regimen should be determined by the duration of time since the previous dose of paliperidone palmitate.1-3

Management of a Missed Second Initiation Dose of INVEGA SUSTENNAa,1, 3

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Timing of Missed Second Initiation Dose

Dosing
<4 weeks since first injection

Administer the second initiation dose of 156 mg in the deltoid muscle as soon as possible

  1. It is recommended to administer a third injection of 117 mg in either the deltoid or gluteal muscle 5 weeks after the first injection (regardless of the timing of the second injection).

  2. Thereafter, resume regular monthly dosing in either the deltoid or gluteal muscle.

4 to 7 weeks since first injection

Resume dosing with two injections of 156 mg in the following manner:

  1. Administer a deltoid injection as soon as possible.

  2. Administer a second deltoid injection 1 week later.

  3. Thereafter, resume regular monthly dosing in either the deltoid or gluteal muscle.

>7 weeks since first 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 regular monthly dosing in either the deltoid or gluteal muscle.

aDeviations from the recommended initiation regimen may lead to sub-therapeutic concentrations, therefore the doses should be administered as close to the recommended schedule as possible. Three scenarios of a missed second initiation dose were evaluated in a population PK model, and considerations for the management of a missed second initiation dose were developed.

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.