Pregnancy & Lactation : הריון/הנקה

4.6 Fertility, pregnancy and lactation

Fertility
Oral administration of sertindole was shown to impair male fertility in mice and rats at systemic exposures similar to or less than that anticipated in humans at the maximum recommended clinical dose.
The adult male fertility impairment, which was reversible, was likely to be due to α1-adrenoceptor antagonism. Offspring of sertindole-treated female rats have also shown reduced mating and fertility (see section 5.3).
In humans, adverse events such as hyperprolactinaemia, galactorrhoea, erectile dysfunction, ejaculation disorder and ejaculation failure have been reported. These events may have a negative impact on female and/or male sexual function and fertility.
If clinical significant hyperprolactinaemia, galactorrhoea or sexual dysfunctions occur, a dose reduction (if possible) or discontinuation should be considered.

The effects are reversible on discontinuation.

Pregnancy

The safety of sertindole for use during pregnancy has not been established.

Sertindole was not teratogenic in animal reproduction studies. A peri/postnatal study in rats showed a decrease in offspring fertility at a dose within the therapeutic range for humans (see section 5.3).

Consequently, sertindole should not be used during pregnancy.

Neonates exposed to antipsychotics (including Serdolect) during the third trimester of pregnancy are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms that may vary in severity and duration following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder. Consequently, newborns should be monitored carefully.

Lactation
Studies in nursing mothers have not been performed, however, it is expected that sertindole will be excreted in breast milk.
If treatment with sertindole is considered necessary, discontinuation of breast-feeding should be considered.