Dosing Window for 2nd Initiation Dose

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Dose Information

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INVEGA SUSTENNA® Dosing Window for 2nd Initiation Dose

Consistent with the INVEGA SUSTENNA® Prescribing Information:

  • Initiate with two doses a week apart both in the deltoid muscle. Administer INVEGA SUSTENNA® 234 mg followed by 156 mg one week later (Week 1).
  • Administer in the deltoid muscle during initiation. The peak paliperidone plasma concentration is approximately 28% higher following an initiation dose in the deltoid vs. gluteal muscle.
  • The initiation regimen (234 mg followed by 156 mg one week later, both in the deltoid muscle) rapidly attains steady-state paliperidone concentrations with no need for oral antipsychotic supplementation.
  • Flexible dosing window: to help avoid a missed dose, patients may be given the second initiation dose 4 days before or after the Week 1 time point.
  • Administration: Each injection must be administered only by a healthcare professional. INVEGA SUSTENNA® is intended for intramuscular use only. Do not administer by any other route. Avoid inadvertent injection into a blood vessel.

INVEGA SUSTENNA® Prescribing Information [http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/INVEGA+SUSTENNA-pi.pdf]

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X-Axis

This axis represents time in weeks. Dose labels along the x-axis represent individual injections. Squares represent the two initiation doses of INVEGA SUSTENNA®. Circles represent maintenance doses of INVEGA SUSTENNA®.

First Initiation Dose - Fixed

The injection location (deltoid muscle) and dosage strength (234 mg) of the first initiation dose is fixed and unable to be adjusted per the INVEGA SUSTENNA® Prescribing Information. Within this resource, the first initiation dose is pre-set to be represented as Day 1 on the x-axis.

Second Initiation Dose - Adjustable Dosing Window

The injection location (deltoid muscle) and dosage strength (156 mg) of the second initiation dose is fixed and unable to be adjusted per the INVEGA SUSTENNA® Prescribing Information. However, to help avoid a missed dose, some scenarios will allow you to shift the timing of this dose (±4 days) within the acceptable dosing window by clicking and dragging the dose label on the x-axis to the left or right.

Maintenance Doses

Some scenarios will allow you to change the injection location, dosage strength, and timing of maintenance doses within the acceptable dosing window to help avoid a missed dose. To do so, either click or tap on the dose label on the x-axis to view options, or click and drag the label to the left or right to adjust the dosage timing. You may also apply the adjustments to all future doses by clicking the Apply to All Future Doses button.

Please note: Any adjustments you make to a scenario will not be saved once you view another scenario or leave this website.

Y-Axis

This axis represents the typical paliperidone plasma concentration in nanograms per milliliter (ng/mL). Since efficacy and specific levels will vary from patient to patient, the concentration depicted is not intended to represent or imply therapeutic blood levels of paliperidone.

Oral INVEGA® 6-12 mg/day Exposure Range

The light gray shaded area of the graph illustrates the estimated exposure range from use of oral INVEGA® 6-12 mg/day. The upper line represents the median paliperidone plasma concentration of oral INVEGA® 12 mg/day, and the lower line represents the median paliperidone plasma concentration of oral INVEGA® 6 mg/day.

Individual Dose Curves

These light orange lines illustrate the paliperidone plasma concentration of one single dose. Each dose contributes to the total concentration in the body.

Cumulative Paliperidone Plasma Concentration Curve

This orange line indicates the cumulative paliperidone plasma concentration in the body over time. Each individual dose contributes to this curve. Changing the timing, injection location, or dosage strength of any dose will affect the total concentration curve.

Learning Points

Clicking on these thought bubbles will reveal additional educational information about the scenario.

The Graph Legend

The legend dropdown indicates what each graph element represents.

Dosing Scenarios Menu

Along the top, there is a list of all available dosing scenarios in the INVEGA SUSTENNA® Prescribing Information.

Graph Information Button

Clicking this button will open additional background information about the dosing scenario.

Zoom Levels

This feature allows you to change the time span of the visible graph area. Some scenarios are illustrated best by a shorter or longer timeframe, so the default view will vary by scenario.

What is the goal of the Educational Dose Illustrator

The Educational Dose Illustrator can be used to visualize how dosing affects paliperidone plasma concentrations following administration of INVEGA SUSTENNA®. This resource simulates the paliperidone plasma concentrations over time resulting from different dosing scenarios that are set forth in the INVEGA SUSTENNA® Prescribing Information.

The Educational Dose Illustrator is intended to be used as a resource to foster a better understanding and educate healthcare professionals about the dosing recommendations provided in the INVEGA SUSTENNA® Prescribing Information. It is intended for educational purposes only. It is not intended to influence prescribing practices. It is not intended to be used to determine patient prescribing dosages, treatment, or dosing strategies. Because the simulated patient blood plasma levels of INVEGA SUSTENNA® shown in the dosing scenarios are based upon aggregated pharmacokinetic information from clinical studies, the simulations may not be representative of individual patient response.

Wilson, WH. A visual guide to expected blood levels of long-acting injectable risperidone in clinical practice. J Psychiatr Pract 2004;10(6): 393-401.

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

What are the key assumptions to the mathematical modeling approach used in this resource?

The Educational Dose Illustrator is based upon the following assumptions:

  • A cumulative (total) paliperidone plasma concentration during treatment with INVEGA SUSTENNA® can be determined by calculating the sum of paliperidone plasma levels attributed to each individual dose
  • The paliperidone plasma level attributed to any one dose can be considered the same as if the injection were given as a single dose
  • These assumptions are plausible because the pharmacokinetics of paliperidone after administering INVEGA SUSTENNA® are linear and time-independent (e.g., there is no significant induction or concentration- or time-dependent clearance, nor other complicating pharmacokinetic factors with INVEGA SUSTENNA®)

These assumptions have been tested by referencing empirical data and pharmacokinetic modeling. This information is for educational purposes only and is not intended to advise prescribing decisions or dosing strategies.

How have the data with with INVEGA SUSTENNA® from this mathematical model been validated?

The modeling data have been verified through two methods:

  1. Comparison with empirical evidence
  2. Comparison with predictions generated through population-pharmacokinetic modeling & simulation

Acknowledging that the simplified non-compartmental superposition technique may result in slightly different predictions than the population pharmacokinetic methodology, the outcomes of the mathematical model are similar to these two sources. This information is for educational purposes only and is not intended to advise prescribing decisions or dosing strategies.

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

How is the cumulative paliperidone plasma concentration determined?

The cumulative paliperidone plasma concentration is determined by first graphing the expected plasma levels attributable to each individual dose (light orange lines). To present the cumulative paliperidone plasma concentration curve (dark orange line), plasma concentrations from all prior administrations are summed. This information is for educational purposes only and is not intended to advise prescribing decisions or dosing strategies.

Wilson, WH. A visual guide to expected blood levels of long-acting injectable risperidone in clinical practice. J Psychiatr Pract 2004;10(6): 393-401

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

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Educational Dose Illustrator for:
INVEGA SUSTENNA® (paliperidone palmitate)
INVEGA TRINZA® (paliperidone palmitate)

The Educational Dose Illustrator can be used to visualize how dosing affects paliperidone plasma concentrations following administration of:

INVEGA SUSTENNA® for:

  • the treatment of schizophrenia in adults
  • the treatment of schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants

INVEGA TRINZA® for:

  • the treatment of schizophrenia in patients after they have been adequately treated with INVEGA SUSTENNA® for at least four months.

This resource simulates the paliperidone plasma concentrations over time resulting from different dosing scenarios that are set forth in the respective Prescribing Information for INVEGA SUSTENNA® and INVEGA TRINZA®. The Educational Dose Illustrator is intended to be used as a resource to foster a better understanding of, and educate healthcare professionals about, the dosing recommendations provided in the respective Prescribing Information for INVEGA SUSTENNA® and INVEGA TRINZA®. It is intended for educational purposes only.

Because the simulated patient paliperidone plasma levels shown in the dosing scenarios are based upon aggregated pharmacokinetic information from clinical studies, the simulations may not be representative of individual patient response.

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This information is intended for healthcare providers in the United States only.

Last updated 10/23/2026

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