Finerenone

Indications

Finerenone is used for: Chronic Kidney Disease

Adult Dose

Chronic Kidney Disease Indicated to reduce risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease, cardiovascular death, nonfatal myocardial infarction, and hospitalization for heart failure in adults with chronic kidney disease (CKD) associated with type 2 diabetes Starting dose Determine starting dose by eGFR (mL/min/1.73m2) eGFR >60: 20 mg PO once daily eGFR 25-60: 10 mg PO once daily eGFR <25: Not recommended Increase dosage after 4 weeks to the target dose of 20 mg once daily based on eGFR and serum potassium thresholds. Dose adjustment Dose adjustment based on current serum potassium concentration (mEq/L) and current dose Currently taking 10 mg qDay <4.8 mEq/L: Increase dose to 20 mg qDay; if eGFR has decreased by more than 30% compared to previous measurement, maintain 10 mg dose >4.8-5.5 mEq/L: Maintain 10 mg/day >5.5 mEq/L: Withhold dose; consider restarting at 10 mg qDay when potassium <5 mEq/L Currently taking 20 mg qDay <4.8 mEq/L: Maintain 20 mg qDay >4.8-5.5 mEq/L: Maintain 20 mg/day >5.5 mEq/L: Withhold dose; restart at 10 mg qDay when potassium <5 mEq/L Hepatic impairment Mild or moderate (Child-Pugh A or B): No dosage adjustment recommended Severe (Child-Pugh C): Avoid

Child Dose

Renal Dose

Administration

May take with or without food

Contra Indications

Concomitant treatment with strong CYP3A4 inhibitors Adrenal insufficiency

Precautions

Hyperkalemia Can cause hyperkalemia Risk increases with decreasing kidney function and is greater with higher baseline potassium levels or other risk factors for hyperkalemia Measure serum potassium and eGFR before initiating; adjust dose accordingly Do not initiate if serum potassium 5 mEq/L Periodically measure serum potassium during treatment and adjust dose as necessary; more frequent monitoring needed for patients at risk for hyperkalemia, including those on concomitant medications that impair potassium excretion or increase serum potassium

Pregnancy-Lactation

Pregnancy Data are not available on 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 ~4 times those expected in humans; clinical significance of these findings is unclear Lactation Data are unavailable on presence in human milk, effects on breastfed infants, or effects on milk production Based on animal studies and potential risk to breastfed infants from exposure, avoid breastfeeding during treatment and for 1 day after last dose Animal studies In a prenatal and postnatal developmental toxicity study in rats, increased pup mortality and lower pup weight were observed at ~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

Interactions

Side Effects

Side effects of Finerenone : >10% Hyperkalemia (18.3%) 1-10% Hypotension (4.8%) Hyponatremia (1.4%)

Mode of Action

Nonsteroidal, selective mineralocorticoid receptor (MR) antagonist, which is activated by aldosterone and cortisol and regulates gene transcription Finerenone blocks MR-mediated sodium reabsorption and MR overactivation in both epithelial (eg, kidney) and nonepithelial (eg, heart, blood vessels) tissues MR overactivation is thought to contribute to fibrosis and inflammation Finerenone has a high potency and selectivity for the MR and has no relevant affinity for androgen, progesterone, estrogen, and glucocorticoid receptors