Trifarotene (Aklief®)

Pregnancy

Trifarotene should not be used during pregnancy because there is not enough human data about the risk of harm to the fetus. Animal studies showed that trifarotene could cause fetal harm. 

Animal studies: Studies in rats and rabbits have demonstrated fetal abnormalities after oral exposure to trifarotene. However, there are also animal study conducted in rats that showed no fetal effects of oral trifarotene. 

Trifarotene should not be used during pregnancy based on studies done on pregnant animals and pharmacology data on retinoids, one of which is trifarotene.

Treatment with trifarotene should begin only if a negative pregnancy test is obtained within 2 weeks of the start of treatment and should be discontinued immediately once a pregnancy is suspected or confirmed. 

Category: Not assigned yet

Category A

Adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters).

Category B

Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

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.

Category D

There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Category X

Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

Breastfeeding

Excretion into human milk: Unknown

There are no adequate studies to determine the risk of trifarotene during breastfeeding. 

Trifarotene is not contraindicated in breastfeeding mothers. However, studies on animals showed that after oral use, rat milk contained trifarotene. This means that, although it is not known for sure, it might be possible to detect trifarotene in human milk in cases when large amounts of trifarotene are applied on the skin. 

To minimize the risk of potential adverse effects of trifarotene on the breastfed infant, your physician may recommend to use trifarotene cream on the smallest area of skin and for the shortest period possible while breastfeeding. 

Furthermore, 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. 

There are no expected adverse effects of trifarotene on milk production.