Iloperidone Pregnancy and Breastfeeding Warnings

Iloperidone is also known as: Fanapt

Iloperidone Pregnancy Warnings

As with other drugs that antagonize dopamine D2 receptors, iloperidone elevates prolactin levels. Hyperprolactinemia may suppress hypothalamic GnRH, resulting in reduced pituitary gonadotropin secretion. This, in turn, may inhibit reproductive function by impairing gonadalsteroidogenesis in both female and male patients. Galactorrhea, amenorrhea, gynecomastia, and impotence have been reported with prolactin elevating compounds. Long standing hyperprolactinemia when associated with hypogonadism may lead to decreased bone density in both female and male patients. In a short-term placebo-controlled trial (4 weeks), the mean change from baseline to endpoint in plasma prolactin levels for the iloperidone 24 mg/day treated group was an increase of 2.6 ng/mL compared to a decrease of 6.3 ng/mL in the placebo group. In this trial, elevated plasma prolactin levels were observed in 26% of adults treated with iloperidone compared to 12% in the placebo group. In short-term trials, iloperidone was associated with modest levels of prolactin elevation compared to greater prolactin elevations observed with some other antipsychotic agents. In pooled analysis from clinical studies including longer term trials, in 3210 adults treated with iloperidone, gynecomastia was reported in 2 male subjects (0.1%) compared to 0% in placebo treated patients, and galactorrhea was reported in 8 female subjects (0.2%) compared to 3 female subjects (0.5%) in placebo treated patients.

Iloperidone has been assigned to pregnancy category C by the FDA. Animal studies have revealed developmental toxicity. There are no controlled data in human pregnancy. Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in these neonates. These complications have varied in severity; while in some cases symptoms have been self-limited, in other cases neonates have required intensive care unit support and prolonged hospitalization. Iloperidone is only recommended for use during pregnancy when benefits outweigh risks.

Iloperidone Breastfeeding Warnings

There are no data on the excretion of iloperidone into human milk. The manufacturer recommends that women receiving iloperidone should not breast-feed.

Animal data have shown that iloperidone was excreted in milk during lactation.

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