Aklief Use In Pregnancy & Lactation

Orally administered retinoids have been associated with congenital abnormalities. When used in accordance with the prescribing information, topically administered retinoids are generally assumed to result into low systemic exposure due to minimal dermal absorption. However, there could be individual factors (e.g. damaged skin barrier, excessive use) that contribute to an increased systemic exposure.
Pregnancy: Aklief is contraindicated (see Contraindications) during pregnancy or in women planning a pregnancy.
Studies in animals with trifarotene by the oral route have shown reproductive toxicity at high systemic exposure (see Pharmacology: Toxicology: Preclinical safety data under Actions).
If the product is used during pregnancy, or if the patient becomes pregnant while taking this drug, treatment should be discontinued.
Breast-feeding: It is unknown whether trifarotene or its metabolites are excreted in human milk.
Available pharmacodynamic/toxicological data in animals have shown excretion of Trifarotene/metabolites in milk (for details see Pharmacology: Toxicology: Preclinical safety data under Actions).
A risk to the suckling child cannot be excluded.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Aklief therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
To avoid the risk of ingestion by, and/or contact exposure of, an infant, nursing women should not apply Trifarotene cream to the chest or breast area.
Fertility: No human fertility studies were conducted with Aklief.
No effects of trifarotene on fertility were found in rats in reproductive studies of oral administration. However, after oral administration to dogs, findings of Germ cell degeneration were observed, see Pharmacology: Toxicology: Preclinical safety data under Actions.