Pregnancy & Lactation : הריון/הנקה

4.6.     Fertility, pregnancy and lactation

Fertility
There are no data on human fertility. Animal studies indicate no effects of fluticasone propionate on male or female fertility.


Pregnancy
There are limited data in pregnant women. Administration of fluticasone propionate during pregnancy should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus. It is important, that the dose of inhaled corticosteroid is titrated to the lowest dose at which effective control is maintained. Treatment with fluticasone propionate should not be stopped abruptly.

Results from a retrospective epidemiological study did not find an increased risk of major congenital malformations) following exposure to fluticasone propionate when compared to other inhaled corticosteroids, during the first trimester of pregnancy (see Section 5.1).

Reproductive studies in animals have shown only those effects characteristic of glucocorticosteroids at systemic exposures in excess of those seen at the recommended inhaled therapeutic dose. There is inadequate evidence of safety of fluticasone propionate in human pregnancy. Administration of corticosteroids to pregnant animals can cause abnormalities of fetal development, including cleft palate and intra-uterine growth retardation. There 
may therefore be a very small risk of such effects in the human fetus. It should be noted, however, that the fetal changes in animals occur after relatively high systemic exposure. Because Flixotide Nebules deliver fluticasone propionate directly to the lungs by the inhaled route the high level of exposure that occurs when corticosteroids are given by systemic routes is avoided. Administration of fluticasone propionate during pregnancy should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus (see Section 5.3).

Breast-feeding
The excretion of fluticasone propionate into human breast milk has not been investigated. When measurable plasma levels were obtained in lactating laboratory rats following subcutaneous administration there was evidence of fluticasone propionate in the breast milk. However, plasma levels in patients following inhaled application of fluticasone propionate at recommended doses are likely to be low.

Administration during lactation should only be considered if the expected benefit to the mother is greater than any possible risk to the child.