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® and INVEGA TRINZA®. This resource simulates the paliperidone plasma concentrations over time resulting from different dosing scenarios that are set forth in the 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 and educate healthcare professionals about the dosing recommendations provided in the Prescribing Information for INVEGA SUSTENNA® and INVEGA TRINZA®. 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® and INVEGA TRINZA® shown in the dosing scenarios are based upon aggregated pharmacokinetic information from clinical studies, the simulations may not be representative of individual patient response.
Describe the pharmacokinetic models used to simulate the scenarios
The simulations were conducted using a 1-compartment model with parallel zero and first-order absorption to describe the pharmacokinetics of INVEGA SUSTENNA® 1 and a 1-compartment model with two saturable absorption processes described the pharmacokinetics of INVEGA TRINZA®2.
This information is for educational purposes only and is not intended to advise prescribing decisions or dosing strategies.
1. Samtani MN, Vermeulen A, Stuyckens K. Population pharmacokinetics of intramuscular paliperidone palmitate in patients with schizophrenia: a novel once-monthly, long-acting formulation of an atypical antipsychotic. Clin Pharmacokinet 2009;48(9):585-600.
2. Magnusson MO, Samtani MN, Plan EL, et al. Population pharmacokinetic simulations of two paliperidone palmitate formulations. Poster presented at the Population Approach Group In Europe; June 2-5, 2015; Crete, Greece.
How has the pharmacokinetic model for INVEGA TRINZA® been validated?
The pharmacokinetic characteristics of paliperidone when administered as a single1 and multiple2 injections of paliperidone palmitate 3-month were well captured by the developed population pharmacokinetic model3 for paliperidone palmitate 3-month.
This information is for educational purposes only and is not intended to advise prescribing decisions or dosing strategies.
1. Ravenstijn P, Remmerie B, Savitz A, et al. pharmacokinetics, safety, and tolerability of paliperidone palmitate 3-month formulation in patients with schizophrenia: a phase-1, single-dose, randomized, open-label study. J Clin Pharmacol 2015 doi: 10.1002/jcph.597. [Epub ahead of print]
2. Berwaerts J, Liu Y, Gopal S, et al. Efficacy and safety of the 3-month formulation of paliperidone palmitate vs placebo for relapse prevention of schizophrenia - a randomized clinical trial. JAMA Psychiatry 2015;72(8):830-839.
3. Magnusson MO, Samtani MN, Plan EL, et al. Population pharmacokinetic simulations of two paliperidone palmitate formulations. Poster presented at the Population Approach Group In Europe; June 2-5, 2015; Crete, Greece.