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Prolactin elevations1,2*
Potentially prolactin-related adverse reactions1,3†
*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.
†Prolactin adverse reaction reports among all patients in the double-blind phase, regardless of baseline prolactin levels.
‡One female on INVEGA TRINZA® reported amenorrhea.
Prolactin elevations1,2*
Potentially prolactin-related adverse reactions1,3†
Most commonly observed potentially prolactin-related adverse reactions (≥3%) | ||
---|---|---|
FEMALES | MALES | |
Amenorrhea | 4.7% (6/127) | Not applicable |
Galactorrhea | 3.1% (4/127) | 0% (0/379) |
*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.
†During the open-label phase, subjects received several doses of INVEGA SUSTENNA® 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
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