Finerenone
Generic Name: finerenone
Brand Names:
Kerendia
11 DESCRIPTION Kerendia contains finerenone, a nonsteroidal mineralocorticoid receptor antagonist. Finerenone's chemical name is ( 4S ) - 4-(4-cyano-2- methoxyphenyl)-5-ethoxy-2,8-dimethyl-1,4-dihydro-1,6-naphthyridine-3-carboxamide. The molecular formula is C 21 H 22 N 4 O 3 and the molecular weight is 378.43 g/mol. The structural formula is: Finerenone is a white to yellow crystalline powder. It is practically insoluble in water; and sparingly soluble in 0.1 M HCl, ethanol, and acetone.
Overview
11 DESCRIPTION Kerendia contains finerenone, a nonsteroidal mineralocorticoid receptor antagonist. Finerenone's chemical name is ( 4S ) - 4-(4-cyano-2- methoxyphenyl)-5-ethoxy-2,8-dimethyl-1,4-dihydro-1,6-naphthyridine-3-carboxamide. The molecular formula is C 21 H 22 N 4 O 3 and the molecular weight is 378.43 g/mol. The structural formula is: Finerenone is a white to yellow crystalline powder. It is practically insoluble in water; and sparingly soluble in 0.1 M HCl, ethanol, and acetone.
Uses
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%.
Dosage
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) ].
Side Effects
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.
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.
Warnings
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) ] . 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.
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.
Storage
16.2 Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions are permitted from 15°C to 30°C (59°F to 86°F ) [see USP Controlled Room Temperature].
Frequently Asked Questions
What is Finerenone used for?▼
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%.
What are the side effects of Finerenone?▼
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.
Can I take Finerenone during 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.
What are the important warnings for Finerenone?▼
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) ] . 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.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.