INVEGA SUSTENNA® Prolactin Data

Prolactin Elevations

Prolactin elevations* in the double-blind phase of the long-term maintenance trial in schizophrenia1

Prolactin elements

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

Please see Important Safety Information.

*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.

Percentage of Patients

Percentage of patients with potentially prolactin-related adverse reactions* in the double-blind phase of the long-term maintenance trial in schizophrenia1

Prolactin percentage

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

Please see Important Safety Information.

*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.

Reference: 1. INVEGA SUSTENNA® [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc.; January 2019.