INVEGA TRINZA® Prolactin Data

Observed in the Double-blind Phase

Prolactin Elevations1,2*

prolactin-double-blind
*Elevations of prolactin to above the reference range (>13.13 ng/mL in males and >26.72 ng/mL in females) relative to open-label baseline at any time during the double-blind phase.

% of Patients with Potentially Prolactin-related Adverse Reactions1,2*

percent_of_patients_double_blind

*Prolactin adverse reaction reports among all patients in the double-blind phase, regardless of baseline prolactin levels.

†One female on INVEGA TRINZA® reported amenorrhea.

Observed in the Open-label Phase*†

Prolactin Elevations1,2

prolactin-open-label

% of Patients with Potentially Prolactin-related Adverse Reactions1,2‡

percent-of-patients-open-label

*Elevations of prolactin to above the reference range (>13.13 ng/mL in males and >26.72 ng/mL in females) during the open-label phase relative to baseline.

†During the open-label phase, subjects received several doses of INVEGA SUSTENNA® (paliperidone palmitate) followed by a single dose of INVEGA TRINZA®.

‡Prolactin adverse reaction reports among all patients in the open-label phase, regardless of baseline prolactin levels

HYPERPROLACTINEMIA: As with other drugs that antagonize dopamine D2 receptors, INVEGA TRINZA® elevates prolactin levels, and the elevation persists during chronic administration. Paliperidone has a prolactin-elevating effect similar to risperidone, which is associated with higher levels of prolactin elevation than other antipsychotic agents.1

References: 1. INVEGA TRINZA® [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc.; January 2019. 2. Data on file. Janssen Pharmaceuticals, Inc., Titusville, NJ.