Kerendia Use In Pregnancy & Lactation

Effects on Fertility: No human data on the effect of KERENDIA on fertility are available. No effect on male fertility was observed with finerenone in rats at oral doses up to 30 mg/kg/day (estimated to yield 16 times the exposure in patients at the maximum recommended human dose of 20 mg/day [based on plasma AUC for unbound drug]). In female rats, inhibition of ovulation was seen with treatment at 30 mg/kg/day (yielding 21 times the clinical exposure), while no effect on female fertility was observed at 3 mg/kg/day (relative exposure, 10). Based on these animal data and the margin of exposure, impairment of male and female fertility is not expected in patients.
Use in Pregnancy (Category D): There are no data on the use of KERENDIA in pregnant women.
Adverse effects on embryofetal development, including teratogenicity, were observed with finerenone in animals. Placental transfer of finerenone and/or its metabolites was demonstrated in the rat.
Administration of finerenone to pregnant rats reduced fetal weight and impaired fetal ossification at oral doses ≥10 mg/kg/day. Increased external and skeletal variations (slight oedema, shortened umbilical cord and slightly enlarged fontanelle) and malformation of the aortic arch were observed at 30 mg/kg/day. These doses yield exposure 19-25 times higher than in patients at the maximum recommended human dose of 20 mg/day (based on plasma AUC for unbound drug), and were maternotoxic. Maternal dosing with finerenone at ≥3 mg/kg/day during gestation and lactation (relative exposure, 4) decreased birth weight, increased perinatal mortality and slightly increased locomotor activity of rat pups. At 10 mg/kg/day, postnatal body weight gain was reduced and development delayed. The observed effect on neurobehaviour is consistent with a pharmacologically-mediated antidepressant-like effect of finerenone as a result of exposure in the fetal brain in utero. No adverse effects on embryofetal development were observed with finerenone in rabbits up to the highest dose tested (2.5 mg/kg/day, yielding 13 times the clinical exposure).
KERENDIA 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).
Women of childbearing potential / Contraception: KERENDIA may cause embryofetal harm when administered during pregnancy. Women of childbearing potential should use effective contraception during treatment with KERENDIA (see Precautions).
Use in Lactation: It is unknown whether finerenone or its metabolites are excreted in human breast milk. Excretion of finerenone and its metabolites in milk was shown in rats. Rat pups exposed to finerenone in utero and through consumption of maternal milk showed adverse effects (see as previously mentioned). A risk to the nursing infant cannot be excluded. Breastfeeding should be discontinued if use of KERENDIA is considered essential (see Precautions).