Pregnancy

There are no adequate and well-controlled studies of topically administered azelaic acid in pregnant women.

Animal studies do indicate the potential for effects with respect to pregnancy, embryo-fetal development, parturition or postnatal development. However, the dose levels without observed adverse effects in animals ranged across studies from 3-32 times the maximum recommended human dose based on body surface area.

Caution should be exercised when prescribing azelaic acid to pregnant women.

Nursing Mothers

It is not known if azelaic acid is passed into breast milk in vivo.

However an in vitro equilibrium dialysis experiment demonstrated that passage of drug into maternal milk may occur. But the distribution of azelaic acid into maternal milk is not expected to cause a significant change from baseline azelaic acid levels in the milk.

Due to low percutaneous absorption and since azelaic acid is not concentrated in milk, the amount of azelaic acid reaching the infant via mother’s milk is approximately 0.01%. This corresponds to less than 200 ╬╝g per day following administration of the maximum recommended dose of 5 g azelaic acid cream twice daily. Caution should be exercised when azelaic acid is administered to a nursing mother.

Azelaic acid is not concentrated in milk and less than 4% of topically applied azelaic acid is systemically absorbed, not increasing endogenous azelaic acid exposure above physiological levels. However, caution should be exercised when azelaic acid gel is administered to a nursing woman.

Infants must not come into contact with treated skin/breast.

Carcinogenesis, Mutagenesis and Fertility

Fertility

There are no data on the effect of azelaic acid on human fertility. Results from animal studies showed no effect on fertility in male or female rats.

Effects on Ability to Drive and Use Machines

Azelaic acid has no influence on the ability to drive and use machines.