During pregnancy and lactation treatment with Mometasone Furoate should be performed only on the physician's order. Then however, the application on large body surface areas or over a prolonged period should be avoided. There is inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids to pregnant animals can cause abnormalities of fetal development including cleft palate and intra-uterine growth retardation. There are no adequate and well-controlled studies with Mometasone Furoate in pregnant women and therefore the risk of such effects to the human fetus is unknown. However as with all topically applied glucocorticoids, the possibility that fetal growth may be affected by glucocorticoid passage through the placental barrier should be considered. There may therefore be a very small risk of such effects in the human fetus. Like other topically applied glucocorticoids, Mometasone Furoate should be used in pregnant women only if the potential benefit justifies the potential risk to the mother or the fetus.
There are no available data on the presence of SINUVA Sinus Implant in human milk, the effects on the breastfed child or the effects on milk production. Systemic absorption of a single inhaled 400 mcg mometasone dose was less than 1%. It is not known if mometasone furoate is excreted in human milk. Other inhaled corticosteroids, similar to mometasone furoate, are present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for the SINUVA Sinus Implant and any potential adverse effects on the breastfed infant from the SINUVA Sinus Implant.