Trifarotene (Aklief®)

Pregnancy

There is not enough data regarding the use of trifarotene in pregnant women to draw conclusions on its safety during pregnancy.

In animal reproduction studies, oral (not topical) doses of trifarotene administered to pregnant animals during the early stages of pregnancy resulted in serious adverse fetal effects, including fetal deaths and malformations.

Be sure to talk to your doctor before using trifarotene when pregnant or planning to become pregnant.

>> More on How to Treat Acne During Pregnancy

Breastfeeding

There is no data on whether trifarotene is excreted in human milk, the effects on the breastfed infant, or the effects on milk production.

Animal studies have shown that oral (not topical) trifarotene does excrete into animal milk.

Thus, a woman and her doctor should decide whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug use to the mother.

Do not apply trifarotene to the nipple area and make sure the infant’s skin does not come into contact with the areas of skin that have been treated with trifarotene. Make sure to wash your hands after the application of trifarotene.