Strong CYP3A4 Inhibitors: Finerenone is a CYP3A4 substrate. Concomitant use with a strong CYP3A4 inhibitor increases finerenone exposure, which may increase the risk of Finerenone adverse reactions. Concomitant use of Finerenone with strong CYP3A4 inhibitors is contraindicated. Avoid concomitant intake of grapefruit or grapefruit juice.
Moderate and Weak CYP3A4 Inhibitors: Finerenone is a CYP3A4 substrate. Concomitant use with a moderate or weak CYP3A4 inhibitor increases finerenone exposure, which may increase the risk of Finerenone adverse reactions. Monitor serum potassium during drug initiation or dosage adjustment of either Finerenone or the moderate or weak CYP3A4 inhibitor, and adjust Finerenone dosage as appropriate.
Strong and Moderate CYP3A4 Inducers: Finerenone is a CYP3A4 substrate. Concomitant use of Finerenone with a strong or moderate CYP3A4 inducer decreases finerenone exposure, which may reduce the efficacy of Finerenone. Avoid concomitant use of Finerenone with strong or moderate CYP3A4 inducers.
The following serious adverse reactions are discussed elsewhere in the labeling: Hyperkalemia.
There are no available data on Kerendia use in pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Animal studies have shown developmental toxicity at exposures about 4 times those expected in humans. The clinical significance of these findings is unclear. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
There are no data on the presence of finerenone or its metabolite in human milk, the effects on the breastfed infant or the effects of the drug on milk production. In a pre-and postnatal developmental toxicity study in rats, increased pup mortality and lower pup weight were observed at about 4 times the AUC unbound expected in humans. These findings suggest that finerenone is present in rat milk. When a drug is present in animal milk, it is likely that the drug will be present in human milk. Because of the potential risk to breastfed infants from exposure to Finerenone, avoid breastfeeding during treatment and for 1 day after treatment.
Hyperkalemia: Finerenone can cause hyperkalemia. The risk for developing hyperkalemia increases with decreasing kidney function and is greater in patients with higher baseline potassium levels or other risk factors for hyperkalemia. Measure serum potassium and eGFR in all patients before initiation of treatment with Finerenone and dose accordingly. Do not initiate Finerenone if serum potassium is >5.0 mEq/L. Measure serum potassium periodically during treatment with Finerenone and adjust dose accordingly. More frequent monitoring may be necessary for patients at risk for hyperkalemia, including those on concomitant medications that impair potassium excretion or increase serum potassium.
Pediatric Use: The safety and efficacy of Kerendia have not been established in patients below 18 years of age.
Geriatric Use: Of the 2827 patients who received Kerendia in the FIDELIO-DKD study, 58% of patients were 65 years and older, and 15% were 75 years and older. No overall differences in safety or efficacy were observed between these patients and younger patients. No dose adjustment is required.
Hepatic Impairment: Avoid use of Kerendia in patients with severe hepatic impairment (Child Pugh C). No dosage adjustment is recommended in patients with mild or moderate hepatic impairment (Child Pugh A or B). Consider additional serum potassium monitoring in patients with moderate hepatic impairment (Child Pugh B)
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
