Fincard 10

Finerenone is indicated to reduce the risk of:

• Sustained decline in estimated glomerular filtration rate (eGFR)
• End-stage kidney disease
• Cardiovascular death
• Nonfatal myocardial infarction (heart attack)
• Hospitalization for heart failure

It is used as part of a comprehensive treatment plan for eligible patients with CKD and type 2 diabetes.

Pharmacology and Mechanism of Action

Finerenone blocks mineralocorticoid receptors activated by hormones such as aldosterone and cortisol. Overactivation of these receptors can contribute to inflammation and fibrosis in the kidneys, heart and blood vessels.

By blocking these effects, finerenone helps reduce harmful tissue changes and protect kidney and cardiovascular function. It has high selectivity for mineralocorticoid receptors and does not have clinically relevant affinity for androgen, progesterone, estrogen or glucocorticoid receptors.

Treatment may produce a modest reduction in blood pressure.

Pharmacokinetics

Absorption: Finerenone is absorbed orally and has an absolute bioavailability of approximately 44%. Peak plasma concentrations generally occur within 0.5–1.25 hours after dosing. Food does not have a clinically significant effect on overall exposure.

Distribution: Approximately 92% of finerenone is bound to plasma proteins, primarily albumin. Its steady-state volume of distribution is approximately 52.6 L.

Metabolism: It is metabolized mainly by CYP3A4 and to a lesser extent by CYP2C8 into inactive metabolites.

Elimination: Its terminal half-life is approximately 2–3 hours. Around 80% of an administered dose is reported to be excreted in urine, mainly as metabolites.

Dosage and Administration

The dose is determined by the physician based on kidney function and serum potassium levels.

Recommended Starting Dose

eGFR 60 mL/min/1.73 m² or higher: 20 mg orally once daily.

eGFR 25 to below 60 mL/min/1.73 m²: 10 mg orally once daily.

eGFR below 25 mL/min/1.73 m²: Initiation is not recommended.

The usual target dose is 20 mg once daily, provided kidney function and serum potassium results support dose escalation.

Monitoring and Dose Adjustment

Check eGFR and serum potassium before starting treatment.

Do not initiate treatment if serum potassium is above 5.0 mEq/L.

Measure serum potassium approximately 4 weeks after starting treatment.

Recheck potassium about 4 weeks after dose adjustments and periodically throughout treatment.

Patients with potassium levels near the upper limit of the acceptable range may require additional monitoring.

The dose should be adjusted according to the prescribing information and the patient's laboratory results.

Administration Instructions

Take once daily, with or without food.

Take the medicine regularly as prescribed.

If swallowing the tablet is difficult, ask a pharmacist or doctor whether the specific product can be crushed and mixed with water or soft food.

Missed Dose

Take a missed dose as soon as you remember, but only on the same day. If you remember the next day, skip the missed dose and continue with your regular schedule. Do not take two doses together.

Side Effects of Finerenone

Possible adverse effects include:

Hyperkalemia: Increased potassium in the blood

Hypotension (low blood pressure)

Hyponatremia (low sodium in the blood)

Hyperkalemia is particularly important because it may occur without obvious symptoms and can cause dangerous heart rhythm disturbances.

Seek medical attention promptly if you develop severe weakness, palpitations, fainting or other concerning symptoms.

Precautions and Warnings

Kidney function: Kidney function must be assessed before treatment and monitored during therapy.

High potassium: Finerenone can increase serum potassium. Treatment must not be initiated when potassium exceeds 5.0 mEq/L.

Potassium supplements: Consult your doctor before using potassium supplements or potassium-containing salt substitutes.

Other medicines: Some medicines can increase potassium levels or alter finerenone exposure, increasing the risk of adverse effects.

Liver disease: Avoid use in severe hepatic impairment. Additional potassium monitoring may be appropriate in moderate hepatic impairment.

Blood pressure: Monitor for dizziness or fainting, especially if you also take other blood pressure-lowering medicines.

Do not adjust or discontinue treatment without medical advice.

Drug Interactions

Strong CYP3A4 Inhibitors

These medicines can significantly increase finerenone exposure and the risk of adverse effects. Concomitant use is contraindicated.

Moderate and Weak CYP3A4 Inhibitors

These may increase finerenone exposure. Additional serum potassium monitoring and dose adjustment may be required.

Strong and Moderate CYP3A4 Inducers

These may reduce finerenone exposure and effectiveness. Concomitant use should be avoided.

Grapefruit

Avoid grapefruit and grapefruit juice during treatment because they may increase finerenone exposure.

Inform your doctor about all medicines, supplements and herbal products you use before starting finerenone.

Use in Special Populations

Children and Adolescents

Safety and effectiveness have not been established in patients under 18 years of age.

Older Adults

Routine dose adjustment is generally not required solely because of age. Kidney function and serum potassium should still be monitored.

Hepatic Impairment

No dose adjustment is generally required in mild or moderate hepatic impairment. Additional potassium monitoring may be considered in moderate impairment. Avoid use in severe hepatic impairment (Child-Pugh C).

Pregnancy

Human pregnancy data are limited. Animal studies have shown developmental toxicity at exposures higher than those expected at recommended human doses. Use during pregnancy requires an individualized assessment of potential benefits and risks.

Breastfeeding

Breastfeeding is not recommended during treatment and for 1 day after the last dose, according to the supplied prescribing information. Discuss suitable treatment and feeding options with your healthcare professional.

Overdose

An overdose may cause hyperkalemia. If an overdose is suspected, seek urgent medical attention. Treatment may need to be interrupted under medical supervision, and elevated potassium must be managed appropriately.

Finerenone is unlikely to be efficiently removed by haemodialysis because it is highly bound to plasma proteins.

Therapeutic Class

Nonsteroidal mineralocorticoid receptor antagonists.

Storage Conditions

Store below 30°C.

Protect from light and moisture.

Keep out of the reach of children.