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:
- Comparison with empirical evidence
- 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.