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💊 KERENDIA

Generic: FINERENONE

ORAL FDA Label

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RouteORAL

ManufacturerBayer HealthCare Pharmaceuticals Inc.

SourceFDA Label

✅ Indications & Usage ›

1 INDICATIONS AND USAGE Kerendia is indicated to reduce the risk of: sustained estimated glomerular filtration rate (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 (T2DM). cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adult patients with heart failure with left ventricular ejection fraction (LVEF) ≥ 40%. Kerendia is a non-steroidal mineralocorticoid receptor antagonist (nsMRA) indicated to reduce the risk of: sustained estimated glomerular filtration rate (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 (T2DM). ( 1 ) cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adult patients with heart failure with left ventricular ejection fraction (LVEF) ≥ 40% ( 1 )

💉 Dosage & Administration ›

2 DOSAGE AND ADMINISTRATION The recommended starting dosage is 10 mg or 20 mg orally once daily based on eGFR and serum potassium thresholds. ( 2.1 ) Increase dosage after 4 weeks to the target dose of 20 mg once daily for CKD and T2DM based on eGFR and serum potassium thresholds. ( 2.3 ) Increase dosage after 4 weeks to the target dose of 20 mg or 40 mg once daily for HF with LVEF ≥ 40% based on eGFR and serum potassium thresholds. ( 2.3 ) Tablets may be taken with or without food ( 2.2 )

2.1 Prior to Initiation of Kerendia Measure serum potassium levels and eGFR before initiation. Do not initiate treatment if serum potassium is > 5.0 mEq/L [see Warnings and Precautions (5.1) ].

2.2 Recommended Starting Dosage The recommended starting dose of Kerendia is based on eGFR and is presented in Table 1. Table 1: Recommended Starting Dosage eGFR (mL/min/1.73m 2 ) Starting Dose ≥ 60 20 mg orally once daily ≥ 25 to < 60 10 mg orally once daily < 25 Initiation is not recommended For patients who are unable to swallow whole tablets, Kerendia may be crushed and mixed with water or soft foods such as applesauce immediately prior to use and administered orally [see Clinical Pharmacology (12.3) ] .

2.3 Monitoring and Dosage Adjustment CKD associated with T2DM The target daily dose of Kerendia is 20 mg orally. Measure serum potassium 4 weeks after initiating treatment and adjust dose (see Table 2 ); if serum potassium levels are > 4.8 to 5.0 mEq/L, initiation of Kerendia treatment may be considered with additional serum potassium monitoring within the first 4 weeks based on clinical judgment and serum potassium levels [see Warnings and Precautions (5.1) ]. Measure serum potassium 4 weeks after a dose adjustment and periodically throughout treatment, and adjust the dose as needed (see Table 2 ) [see Warnings and Precautions (5.1) and Drug Interactions (7.1) ]. Table 2: Dose Adjustment Based on Current Serum Potassium Concentration and Current Dose (CKD associated with T2DM) Cu... [See full FDA label]

🚫 Contraindications ›

4 CONTRAINDICATIONS Kerendia is contraindicated in patients: Who are hypersensitive to any component of this product [see Adverse Reactions (6.2) ] . Who are receiving concomitant treatment with strong CYP3A4 inhibitors [see Drug Interactions (7.1) ]. With adrenal insufficiency. Concomitant use with strong CYP3A4 inhibitors. ( 4 , 7.1 ) Patients with adrenal insufficiency. ( 4 ) Hypersensitivity to any component of this product. ( 4 )

⚠️ Warnings & Precautions ›

5 WARNINGS AND PRECAUTIONS Hyperkalemia. Patients with decreased kidney function and higher baseline potassium levels are at increased risk. Monitor serum potassium levels and adjust dose as needed. ( 2.1 , 2.2 , 2.3 , 5.1 ) Worsening of Renal Function in Patients with Heart Failure. Measure eGFR and adjust dose as needed. ( 2.1 , 2.3 , 6.1 )

5.1 Hyperkalemia Kerendia can cause hyperkalemia [see Adverse Reactions (6.1) ] . 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 Kerendia and dose accordingly [see Dosage and Administration (2.1) ] . Do not initiate Kerendia if serum potassium is > 5.0 mEq/L. Measure serum potassium periodically during treatment with Kerendia and adjust dose accordingly [see Dosage and Administration (2.3) ] . 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 [see Drug Interactions (7.1 , 7.2) ] .

5.2 Worsening of Renal Function in Patients with Heart Failure Kerendia can cause worsening of renal function in patients with heart failure. Rarely, severe events associated with worsening renal function, including events requiring hospitalization, have been observed [see Adverse Reactions (6.1) ] . Measure eGFR in all patients before initiation of treatment or with dose titration of Kerendia and dose accordingly [see Dosage and Administration (2.1 , 2.3) ]. Initiation of Kerendia in patients with heart failure and an eGFR <25 mL/min/1.73m 2 is not recommended. Measure eGFR periodically during maintenance treatment with Kerendia in patients with heart failure. Consider delaying up-titration or interrupting treatment with Kerendia in patients who develop clinically significant worsening of renal functi... [See full FDA label]

🔴 Adverse Reactions ›

6 ADVERSE REACTIONS The following serious adverse reactions are discussed elsewhere in the labeling: Hyperkalemia [see Warnings and Precautions (5.1) ] Adverse reactions occurring in ≥ 1% of patients on Kerendia and more frequently than placebo are hyperkalemia, hypotension, and hyponatremia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bayer HealthCare Pharmaceuticals Inc. at 1-888-842-2937 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. CKD associated with T2DM The safety of Kerendia in patients with CKD associated with T2DM was evaluated in 2 randomized, double-blind, placebo-controlled, multicenter pivotal phase 3 studies, FIDELIO-DKD and FIGARO-DKD, in which a total of 6510 patients were treated with 10 or 20 mg once daily over a mean duration of 2.2 and 2.9 years, respectively. Overall, serious adverse events occurred in 32% of patients receiving Kerendia and in 34% of patients receiving placebo in the FIDELIO-DKD study; the findings were similar in the FIGARO-DKD study. Permanent discontinuations due to adverse events also occurred in a similar proportion of patients in the two studies (6-7% of patients receiving Kerendia and in 5-6% of patients receiving placebo). The most frequently reported (≥ 10%) adverse reaction was hyperkalemia [see Warnings and Precautions (5.1) ]. Hospitalization due to hyperkalemia for the Kerendia group was 0.9% vs 0.2% in the placebo group across both studies. Hyperkalemia led to permanent discontinuation of treatment in 1.7% receiving Kerendia versus 0.6% of patients receiving placebo across both studies. Table 4 shows adverse reactions that occurred more commonly on Kerendia than on placebo, and in at least 1% of patients t... [See full FDA label]

💊 Drug Interactions ›

7 DRUG INTERACTIONS Strong CYP3A4 Inhibitors: Use is contraindicated. ( 7.1 ) Grapefruit or grapefruit juice: Avoid concomitant use. ( 7.1 ) Moderate or weak CYP3A4 Inhibitors: Monitor serum potassium during drug initiation or dosage adjustment of either Kerendia or the moderate or weak CYP3A4 inhibitor, and adjust Kerendia dosage as appropriate ( 7.1 ) Strong or moderate CYP3A4 Inducers: Avoid concomitant use. ( 7.1 ) Sensitive CYP2C8 substrates at Kerendia 40 mg: Monitor more frequently for adverse reactions. ( 7.2 )

7.1 Effect of Other Drugs on Kerendia Strong CYP3A4 Inhibitors Kerendia is a CYP3A4 substrate. Concomitant use with a strong CYP3A4 inhibitor increases finerenone exposure [see Clinical Pharmacology (12.3) ] , which may increase the risk of Kerendia adverse reactions. Concomitant use of Kerendia with strong CYP3A4 inhibitors is contraindicated [see Contraindications (4) ] . Avoid concomitant intake of grapefruit or grapefruit juice. Moderate and Weak CYP3A4 Inhibitors Kerendia is a CYP3A4 substrate. Concomitant use with a moderate or weak CYP3A4 inhibitor increases finerenone exposure [see Clinical Pharmacology (12.3) ] , which may increase the risk of Kerendia adverse reactions. Monitor serum potassium during drug initiation or dosage adjustment of either Kerendia or the moderate or weak CYP3A4 inhibitor, and adjust Kerendia dosage as appropriate [see Dosing and Administration (2.3) and Drug Interaction (7.2) ] . Strong and Moderate CYP3A4 Inducers Kerendia is a CYP3A4 substrate. Concomitant use of Kerendia with a strong or moderate CYP3A4 inducer decreases finerenone exposure [see Clinical Pharmacology (12.3) ], which may reduce the efficacy of Kerendia. Avoid concomitant use of Kerendia with strong or moderate CYP3A4 inducers.

7.2 Effect of Kerendia on Other Drugs CYP2C8 Substrates Kerendia is a weak CYP2C8 inhibitor at 40 mg. Kerendia increases exposure of CYP2C8 substrates at 40 mg dose [see Clinical Pharmacology (12.3) ] , which may increase the... [See full FDA label]

🤰 Pregnancy ›

8.1 Pregnancy Risk Summary 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 2 times those expected in humans (see Data ) . 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. Data Animal Data In the embryo-fetal toxicity study in rats, finerenone resulted in reduced placental weights and signs of fetal toxicity, including reduced fetal weights and retarded ossification at the maternal toxic dose of 10 mg/kg/day corresponding to an AUC unbound of at least 7 times that in humans. At 30 mg/kg/day, the incidence of visceral and skeletal variations was increased (slight edema, shortened umbilical cord, slightly enlarged fontanelle) and one fetus showed complex malformations including a rare malformation (double aortic arch) at an AUC unbound of about 10 times that in humans at the 40 mg dose and about 25 times that in humans at the 20 mg dose. The doses free of any findings (low dose in rats, high dose in rabbits) provide safety margins of 4 to 5 times for the AUC unbound expected in humans. When rats were exposed during pregnancy and lactation in the pre- and postnatal developmental toxicity study, increased pup mortality and other adverse effects (lower pup weight, delayed pinna unfolding) were observed at about 2 or 4 times the AUC unbound expected in humans at the dose of 40 mg and 20 mg, respectively. In addition, the offspring showed slightly increased locomotor activity, but no other neurobehavioral chan... [See full FDA label]

👶 Pediatric Use ›

8.4 Pediatric Use The safety and efficacy of Kerendia have not been established in patients below 18 years of age.

👴 Geriatric Use ›

8.5 Geriatric Use Of the 6510 patients who received Kerendia in the FIDELIO-DKD and FIGARO-DKD studies, 55% of patients were 65 years and older, and 14% were 75 years and older. Of the 2993 patients who received Kerendia in the FINEARTS study, 79% of patients were 65 years and older, and 43% 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.

🔬 Mechanism of Action ›

12.1 Mechanism of Action Finerenone is a nonsteroidal, selective antagonist of the mineralocorticoid receptor (MR), which is activated by aldosterone and cortisol and regulates gene transcription. Finerenone 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. Finerenone has a high potency and selectivity for the MR and has no relevant affinity for androgen, progesterone, estrogen, and glucocorticoid receptors.

📊 Pharmacokinetics ›

12.3 Pharmacokinetics Finerenone exposure increased proportionally over a dose range of 1.25 to 80 mg (0.06 to 4 times the maximum approved recommended dosage). Steady state of finerenone was achieved after 2 days of dosing. The estimated steady-state geometric mean C max,md was 166 µg/L and steady-state geometric mean AUC τ,md was 718 µg.h/L following administration of finerenone 20 mg to patients. Absorption Finerenone is completely absorbed after oral administration but undergoes metabolism resulting in absolute bioavailability of 44%. Finerenone C max was achieved between 0.5 and 1.25 hours after dosing. Effect of Food There was no clinically significant effect on finerenone AUC following administration with high fat, high calorie food. Distribution The volume of distribution at steady-state (Vss) of finerenone is

52.6 L. Plasma protein binding of finerenone is 92%, primarily to serum albumin, in vitro. Elimination The terminal half-life of finerenone is about 2 to 3 hours, and the systemic blood clearance is about 25 L/h. Metabolism Finerenone is primarily metabolized by CYP3A4 (90%) and to a lesser extent by CYP2C8 (10%) to inactive metabolites. Excretion About 80% of the administered dose is excreted in urine (<1% as unchanged) and approximately 20% in feces (< 0.2% as unchanged). Specific Populations There are no clinically significant effects of age (18 to 86 years), sex, race/ethnicity (White, Asian, Black, and Hispanic), or weight (54 to 126 kg) on the pharmacokinetics of finerenone. Renal Impairment There were no clinically relevant differences in finerenone AUC or C max values in patients with eGFR 15 to < 90 mL/min/1.73m 2 compared to eGFR ≥ 90 mL/min/1.73 m 2 . For dosing recommendations based on eGFR and serum potassium levels see Dosage and Administration (2) . Hepatic Impairment There was no clinically significant effect on finerenone exposure in cirrhotic patients with mild hepatic impairment (Child Pugh A). Finerenone mean AUC was increased ... [See full FDA label]

☠️ Overdosage ›

10 OVERDOSAGE In the event of suspected overdose, immediately interrupt Kerendia treatment. The most likely manifestation of overdose is hyperkalemia. If hyperkalemia develops, standard treatment should be initiated. Finerenone is unlikely to be efficiently removed by hemodialysis given its fraction bound to plasma proteins of about 90%.

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