Animal studies have not revealed teratogenicity or fertility effects; however, maternal, fetal, and reproductive toxicity have been observed. There are no controlled data in human pregnancy.

AU TGA pregnancy category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Use is recommended only if clearly needed and the benefit outweighs the risk.

AU TGA pregnancy category: B1
US FDA pregnancy category: C

Comments: Fetal exposure in humans should be expected, based on two studies (an in vitro human study and an animal study) which revealed evidence of drug placental transfer.

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A decision should be made to discontinue breastfeeding or to discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments: Drug administered subcutaneously to lactating female animals was distributed to, but did not accumulate in milk.

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