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Fineron 10 mgFineron 10 mg is indicated to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D).Dosage of Fineron 10 mgPrior to Initiation of Kerendia: Measure serum potassium levels and estimated glomerular filtration rate (eGFR) before initiation. Do not initiate treatment if serum potassium is >5.0 mEq/L.Recommended Starting Dosage: The recommended starting dose of Kerendia is based on eGFR. ?60 eGFR (mL/min/1.73 m2): Starting dose 20 mg once daily ?25 to <60 eGFR (mL/min/1.73 m2): Starting dose 10 mg once daily 5.0 mEq/L. Measure serum potassium periodically during treatment with Fineron 10 mg 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.Storage ConditionsKeep below 30?C temperature, away from light & moisture. Keep out of the reach of children.Mode Of ActionFineron 10 mg is a nonsteroidal, selective antagonist of the mineralocorticoid receptor (MR), which is activated by aldosterone and cortisol and regulates gene transcription. Fineron 10 mg blocks MR mediated sodium reabsorption and MR overactivation in both epithelial (e.g., kidney) and nonepithelial (e.g., heart, and blood vessels) tissues. MR overactivation is thought to contribute to fibrosis and inflammation. Fineron 10 mg has a high potency and selectivity for the MR and has no relevant affinity for androgen, progesterone, estrogen, and glucocorticoid receptors.PregnancyThere 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 Fineron 10 mg 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 Fineron 10 mg 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 Fineron 10 mg, avoid breastfeeding during treatment and for 1 day after treatment.Pediatric UsesPediatric 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)