Trifarotene topical Pregnancy and Breastfeeding Warnings

Brand names: Aklief

Medically reviewed by Drugs.com. Last updated on Nov 24, 2023.

Trifarotene topical Pregnancy Warnings

The manufacturer makes no recommendation regarding use during pregnancy.
-According to some authorities: Use is contraindicated.

AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned.

Risk summary: Available data from clinical trials with use of this drug in pregnant women have not identified a drug-related risk of major birth defects, miscarriage, or adverse maternal/fetal outcomes.

Comments:
-There are case reports of major birth defects (like those seen in fetuses exposed to oral retinoids) in pregnant women exposed to other topical retinoids; these case reports did not establish a pattern/association with retinoid-related embryopathy.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, discontinue the therapy.

Animal studies have revealed evidence of reproductive toxicity and fetal harm (including fetal deaths and external, visceral, and skeletal malformations) with oral doses that resulted in systemic exposures more than 800 times the systemic exposure at the maximum recommended human dose (MRHD). Oral doses administered to pregnant rats and pregnant rabbits resulted in systemic exposures greater than 1600 times and at least 800 times, respectively, the systemic exposure in humans at the MRHD and led to adverse fetal effects (including fetal deaths, reduced mean fetal weigh, and external/visceral/skeletal malformations in rats; defects of the tail, limbs, urogenital organs, and vertebral column in rabbits). Oral administration of this drug to dogs resulted in germ cell degeneration. There are no controlled data in human pregnancy.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Trifarotene topical Breastfeeding Warnings

Safety has not been established. Benefit should outweigh risk.

Excreted into human milk: Unknown
Excreted into animal milk: Yes (with oral administration)

Comments:
-When a drug is present in animal milk, it is likely that the drug will be present in human milk.
-Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug.
-The effects in the nursing infant are unknown; potential side effects in the breastfed child due to this drug or the mother's underlying condition should be considered.
-Topical application of large amounts of this drug could possibly result in enough systemic absorption to produce detectable quantities in human milk.
-While breastfeeding, this drug should be used on the smallest area of skin for the shortest duration possible to minimize potential exposure to the nursing infant via breast milk; to avoid direct infant exposure, breastfeeding women should be advised not to apply this drug directly to the nipple and areola.

See references

Further information

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