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Changes in prolactin levels were evaluated in a longer-term study

Hyperprolactinemia: As with other drugs that suppress dopamine D₂ receptors, INVEGA SUSTENNA^® can elevate 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

Elevated prolactin levels in patients taking INVEGA SUSTENNA^®

Hyperprolactinemia may suppress hypothalamic GnRH, resulting in reduced pituitary gonadotrophin secretion. This, in turn, may inhibit reproductive function by impairing gonadal steroidogenesis in both female and male patients. Galactorrhea, amenorrhea, gynecomastia, and impotence have been reported in patients receiving prolactin-elevating compounds. Long-standing hyperprolactinemia when associated with hypogonadism may lead to decreased bone density in both female and male patients¹
Counsel patients on signs and symptoms of hyperprolactinemia that may be associated with chronic use of INVEGA SUSTENNA^®. Advise them to seek medical attention if they experience any of the following: amenorrhea or galactorrhea in females; erectile dysfunction or gynecomastia in males¹

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

Bar graph showing prolactin elevations in the double-blind phase of the long-term maintenance trial in schizophrenia.

Percentage of patients with potentially prolactin-related adverse reactions in the double-blind phase of the long-term maintenance trial in schizophrenia^1†

Bar graph showing percentage of patients with potentially prolactin-related adverse reactions in the double-blind phase of the long-term maintenance trial in schizophrenia

*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.

^†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.

Changes in prolactin levels were evaluated in a longer-term study

Elevated prolactin levels in patients taking INVEGA SUSTENNA®

Elevated prolactin levels in patients taking INVEGA SUSTENNA^®