Pregnancy & Lactation : הריון/הנקה

4.6 FERTILITY, PREGNANCY AND LACTATION
Effects on fertility
There were no effects on mating performance or fertility of male or female rats in which systemic exposure to fluticasone furoate was achieved by inhalational administration.
Use in pregnancy
(Pregnancy Category B3)
There is insufficient evidence of safety of fluticasone furoate in human pregnancy.
Systemically absorbed corticosteroids are known to induce fetotoxic and teratogenic effects in rodent studies. However, equivalent effects have not been reported when these compounds have been given to humans during pregnancy. Following intranasal administration of fluticasone furoate at the maximum recommended human dose (110 micrograms per day), plasma concentrations were typically non-quantifiable (See Section 5.2 PHARMACOKINETIC PROPERTIES). Fetal exposure and therefore potential for reproductive toxicity is expected to be very low. As with other compounds of this class, the use of AVAMYS during pregnancy should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus.
Use in lactation
The excretion of fluticasone furoate into human breast milk has not been investigated.
Related drugs are known to be excreted in the milk of lactating rats. However, plasma levels in patients following intranasal application of fluticasone furoate at recommended doses are low, and therefore the amount of fluticasone ingested by the newborn is likely to be very small.