INVEGA SUSTENNA® is approved for the treatment of schizoaffective disorder

INVEGA SUSTENNA® Prolactin Elevations and Potentially Prolactin-Related Events

Prolactin elevations* observed in the double-blind phase of the long-term maintenance trial in schizophrenia1,2
2 charts illustrating the impact that INVEGA SUSTENNA® had on patients observed in a clinical study
*Elevations of prolactin to above the reference range (>18 ng/mL in males and >30 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 phase of the long-term maintenance trial in schizophrenia1,2
2 charts illustrating the impact that INVEGA SUSTENNA® had on patients observed in a clinical study

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

In the INVEGA SUSTENNA® group, 2 females reported amenorrhea,1 reported galactorrhea, and 1 reported irregular menstruation, while in the placebo group, 1 female reported amenorrhea and 1 reported breast pain.

§In the INVEGA SUSTENNA® group, 1 male reported erectile dysfunction and in the placebo group, 1 male reported gynecomastia.

Prolactin elevationsII observed in the 33-week open-label phase of the long-term maintenance trial in schizophrenia1,2
2 charts illustrating the impact that INVEGA SUSTENNA® had on patients observed in a clinical study
IIElevations of prolactin to above the reference range (>18 ng/mL in males and >30 ng/mL in females) relative to baseline during the open-label phase.
% of patients with potentially prolactin-related adverse reactions in the open-label phase of the long-term maintenance trial in schizophrenia1,2

Amenorrhea (2.5%) in females and no single potentially prolactin-related adverse reaction in males were observed with a rate >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 SUSTENNA® 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 SUSTENNA® [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc.; March 2018. 2. Data on file. Janssen Pharmaceuticals, Inc., Titusville, NJ.

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