For patients who have never taken oral paliperidone or oral or injectable risperidone, establish tolerability with oral paliperidone or oral risperidone prior to initiating INVEGA SUSTENNA.¹

INVEGA SUSTENNA is designed to deliver paliperidone over a monthly period while ER oral paliperidone is administered on a daily basis. Figure: Median Paliperidone Plasma Concentration-Time Profiles for INVEGA SUSTENNA and Paliperidone ER for 5 Weeks illustrates the recommended initiation dosing regimen for INVEGA SUSTENNA compared to oral paliperidone ER doses of 6 and 12 mg once daily.¹

In a PK simulation modeling study in patients with schizophrenia, data suggest that, after the initial dose of 234-mg paliperidone palmitate given on day 1 by IM deltoid injection, patients should receive 156-mg paliperidone palmitate on day 8 by IM deltoid injection. This regimen (234 mg followed by 156 mg one week later, both administered in the deltoid muscle) rapidly achieves plasma paliperidone levels that are similar to those observed at steady state with the suggested monthly dose of paliperidone palmitate 117 mg as well as the daily oral dose of paliperidone ER 6 mg.²

Additionally, schizophrenia clinical trial data and population PK simulations suggest that the effect of body mass index on paliperidone plasma concentrations can be mitigated through administration of the day 1 (234 mg) and day 8 (156 mg) IM injections in the deltoid muscle with a longer 1½-inch needle in patients weighing >90 kg and a shorter 1-inch needle in patients weighing < 90 kg. ¹

ER, extended release; IM, intramuscular; PK, pharmacokinetic.