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INVEGA TRINZA® Prolactin Data
Observed in the double-blind phase
Prolactin elevations* in the double-blind phase1,2
*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 reactions† in the double-blind phase1,2
†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 elevations§ in the 29-week open-label phase1,2‖
§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®.
% of patients with potentially prolactin-related adverse reactions¶ in the open-label phase1,2
¶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.; February 2017. 2. Data on file. Janssen Pharmaceuticals, Inc., Titusville, NJ.