Firialta Use In Pregnancy & Lactation

Pregnancy: There are no data on the use of Finerenone (Firialta) in pregnant women. Animal studies have shown embryo-fetal developmental toxicity at exposures in excess to the maximum human exposure. In the pre- and post-natal developmental toxicity study, slightly increased locomotor activity was found in the offspring, which may have been caused by exposure during pregnancy (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Finerenone (Firialta) should not be used during pregnancy unless there has been careful consideration of the benefit for the mother and the risk to the fetus (see Precautions).
Lactation: It is unknown whether finerenone or its metabolites are excreted in human breast milk. Available pharmacokinetic and toxicological data in animals have shown excretion of finerenone and its metabolites in milk. Rat pups exposed by this route showed adverse effects (see Pharmacology: Toxicology: Preclinical safety data under Actions). A risk to the nursing infant cannot be excluded. Breastfeeding should be discontinued if use of Finerenone (Firialta) is considered essential (see Precautions).
Fertility: No human data on the effect of Finerenone (Firialta) on fertility is available. Animal studies with finerenone did not indicate a risk of impaired male fertility. Animal studies with finerenone indicated impaired female fertility at exposures considered sufficiently in excess to the maximum human exposure indicating no clinical relevance. (See Pharmacology: Toxicology: Preclinical safety data under Actions.)
Women of childbearing potential/Contraception: Finerenone (Firialta) may cause embryo-fetal harm when administered during pregnancy. Women of childbearing potential should use effective contraception during treatment with Finerenone (Firialta) (see Precautions).