Pregnancy & Lactation : הריון/הנקה

4.6    Fertility, pregnancy and lactation

Pregnancy
There are no data from the use of inhaled liposomal amikacin in pregnant women. Systemic exposure to amikacin following inhalation of inhaled liposomal amikacin is expected to be low compared to parenteral administration of amikacin.

There are limited data from the use of aminoglycosides in pregnant women. Aminoglycosides can cause foetal harm. Aminoglycosides cross the placenta, and there have been reports of total, irreversible, bilateral congenital deafness in children, whose mothers received streptomycin during pregnancy. Although adverse reactions on the foetus or newborns have not been reported in pregnant women treated with other aminoglycosides, the potential for harm exists. Animal reproductive toxicity studies have not been conducted with inhaled amikacin. In reproductive toxicity studies in mice, rats and rabbits with amikacin administered parenterally, no foetal malformations were reported.

As a precautionary measure, it is preferable to avoid the use of inhaled liposomal amikacin during pregnancy.

Breast-feeding

There is no information regarding the presence of amikacin in human milk. However, systemic exposure to inhaled liposomal amikacin following inhalation is expected to be low compared to parenteral administration of amikacin.

A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from inhaled liposomal amikacin therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.

Fertility

No fertility studies were conducted with inhaled liposomal amikacin.