Brand Name

Kerendia

Generic Name
Finerenone
View Brand Information
FDA approval date: July 09, 2021
Classification: Nonsteroidal Mineralocorticoid-Receptor Antagonist
Form: Tablet

What is Kerendia (Finerenone)?

Living with type 2 diabetes often means managing not just blood sugar, but also its effects on other organs, especially the kidneys and heart. Over time, diabetes can damage blood vessels and filtering units in the kidneys, leading to chronic kidney disease (CKD). Kerendia (finerenone) is a newer medication developed to help slow down this damage and protect both kidney and heart health.

Kerendia is a nonsteroidal mineralocorticoid receptor antagonist (MRA), a targeted drug class that works differently from traditional diuretics or blood pressure medicines. It was approved by the U.S. Food and Drug Administration (FDA) in 2021, marking a significant step forward in the treatment of diabetic kidney disease.

By addressing inflammation and scarring inside the kidneys, Kerendia helps patients with chronic kidney disease associated with type 2 diabetes maintain better long-term health and reduce the risk of heart-related complications.

What does Kerendia do?

Kerendia is prescribed for adults with chronic kidney disease (CKD) related to type 2 diabetes. It is not a blood sugar–lowering drug but works alongside standard diabetes and kidney medications, such as ACE inhibitors, ARBs, or SGLT2 inhibitors, to offer extra protection.

Its main goals are to slow kidney disease progression, lower the risk of kidney failure or dialysis, and reduce the risk of heart attacks, strokes, and heart failure hospitalizations.

Clinical studies, including the large FIDELIO-DKD and FIGARO-DKD trials, showed that patients taking Kerendia had significantly lower rates of kidney function decline and fewer cardiovascular events compared to those on placebo (Bakris et al., 2020).

Kerendia prolongs kidney health and reduces heart strain in diabetic kidney disease, improving both life expectancy and quality of life.

How does Kerendia work?

Kerendia works by blocking the effects of the hormone aldosterone on certain receptors in the kidneys, heart, and blood vessels. Aldosterone normally helps regulate salt and water balance, but when its levels are too high, as often happens in diabetes and kidney disease, it can cause inflammation and scarring in these organs.

Kerendia blocks a harmful hormone to reduce kidney inflammation and scarring, lower protein loss in urine, and improve heart and vascular health.

Unlike older steroidal MRAs (like spironolactone), finerenone is nonsteroidal, meaning it is less likely to cause hormonal side effects such as breast tenderness or hormonal imbalances.

Clinically, this mechanism is important because it targets a root cause of diabetic kidney injury, not just its symptoms. That makes Kerendia part of a modern, mechanism-driven approach to slowing disease progression rather than only treating complications as they appear (FDA, 2021).

Kerendia side effects

Kerendia is generally well-tolerated, but because it affects mineral balance in the body, the main concern is elevated potassium levels (hyperkalemia).

Common side effects include:

  • Mild increases in blood potassium
  • Low blood pressure (hypotension)
  • Dizziness or fatigue

Less common or serious side effects:

  • Significant hyperkalemia (which may cause muscle weakness or irregular heartbeat)
  • Worsening kidney function in some patients

Your doctor will check your blood potassium and kidney function regularly especially when starting or adjusting your dose, to ensure Kerendia remains safe and effective.

You should not take Kerendia if you:

  • Have high potassium levels before starting treatment
  • Have severe kidney impairment
  • Are taking other medications that increase potassium, such as certain diuretics or supplements, unless your doctor advises otherwise

If you experience symptoms like muscle weakness, chest pain, or an unusually slow heartbeat, seek medical attention promptly.

Kerendia dosage

Kerendia comes in tablet form and is taken once daily, with or without food. The exact dosage depends on your kidney function and blood potassium levels.

Before and during Kerendia treatment, blood tests will monitor serum potassium and eGFR (kidney function) to guide dose adjustments for safe potassium levels.

Doctors may also review your other medications to prevent interactions, especially with drugs that affect potassium or kidney function.

Kerendia is typically added to a regimen that already includes standard-of-care medications like ACE inhibitors or ARBs, not as a replacement.

For older adults or those with multiple medical conditions, close monitoring ensures that the benefits of kidney and heart protection outweigh any potential risks.

Does Kerendia have a generic version?

As of 2025, Kerendia (finerenone) does not have an FDA-approved generic version. It is currently available only as the brand-name product made by Bayer. However, international versions may exist in other markets.

Since it’s a relatively new medication with patent protection, generic alternatives are not yet on the market. However, many insurance plans offer coverage or co-pay assistance for Kerendia, and patient support programs are available through the manufacturer.

When generics do become available in the future, they will be required by the FDA to have the same active ingredient, strength, and therapeutic effect as Kerendia, ensuring equal safety and efficacy.

Conclusion

Kerendia represents an important advancement for people living with type 2 diabetes and chronic kidney disease. By targeting the underlying processes that cause kidney and heart damage, it offers patients a way to slow disease progression and reduce serious complications that affect longevity and quality of life. Kerendia supplements diabetes/blood pressure medications, providing additional protection without being a cure or replacement.

Regular follow-ups and blood monitoring are essential, but when used under the supervision of a qualified healthcare provider, Kerendia is a safe and effective therapy that supports both kidney and heart health over the long term.

References

  1. Bakris, G. L., et al. (2020). Effect of finerenone on chronic kidney disease outcomes in type 2 diabetes (FIDELIO-DKD). New England Journal of Medicine. https://www.nejm.org/
  2. U.S. Food and Drug Administration (FDA). (2021). FDA approves Kerendia (finerenone) for patients with chronic kidney disease associated with type 2 diabetes. https://www.fda.gov/
  3. Mayo Clinic. (2024). Finerenone (oral route): Uses, side effects, and precautions. https://www.mayoclinic.org/
  4. MedlinePlus. (2024). Finerenone oral: Drug information. https://medlineplus.gov/

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Brand Information

Kerendia (finerenone)
1INDICATIONS 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%.
2DOSAGE FORMS AND STRENGTHS
Kerendia is available as film-coated, oblong tablets in three strengths.
  • 10 mg: pink, with "FI" on one side, "10" on the other side.
  • 20 mg: yellow, with "FI" on one side, "20" on the other side.
  • 40 mg: gray-orange, with "FI" on one side, "40" on the other side.
3CONTRAINDICATIONS
Kerendia is contraindicated in patients:
  • Who are hypersensitive to any component of this product
  • Who are receiving concomitant treatment with strong CYP3A4 inhibitors
  • With adrenal insufficiency.
4ADVERSE REACTIONS
The following serious adverse reactions are discussed elsewhere in the labeling:
  • Hyperkalemia
4.1Clinical 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.
4.2Postmarketing Experience
The following additional adverse reactions have been reported in postmarketing experience with finerenone. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure:
Hypersensitivity: Angioedema, Rash and Urticaria
5OVERDOSAGE
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%.
6DESCRIPTION
Kerendia contains finerenone, a nonsteroidal mineralocorticoid receptor antagonist. Finerenone's chemical name is (
Chemical Structure
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.
Each Kerendia tablet contains 10 mg, 20 mg, or 40 mg of finerenone. The inactive ingredients of Kerendia are lactose monohydrate, cellulose microcrystalline, croscarmellose sodium, hypromellose, magnesium stearate, and sodium lauryl sulfate. The film coating contains hypromellose, titanium dioxide and talc, in addition to ferric oxide red (10 mg and 40 mg strength tablets) or ferric oxide yellow (20 mg and 40 mg strength tablets).
7PATIENT COUNSELING INFORMATION
Advise patients of the need for periodic monitoring of serum potassium levels. Advise patients receiving Kerendia to consult with their physician before using potassium supplements or salt substitutes containing potassium
Advise patients to avoid strong or moderate CYP3A4 inducers and to find alternative medicinal products with no or weak potential to induce CYP3A4
Avoid concomitant intake of grapefruit or grapefruit juice as it is expected to increase the plasma concentration of finerenone
Advise women that breastfeeding is not recommended at the time of treatment with KERENDIA and for 1 day after treatment
8PRINCIPAL DISPLAY PANEL- 10 mg Tablet Carton
NDC 50419-540-01
Kerendia
30 film-coated tablets
BAYER
PRINCIPAL DISPLAY PANEL- 10 mg Tablet Carton
9PRINCIPAL DISPLAY PANEL- 20 mg Tablet Carton
NDC 50419-541-01
Kerendia
30 film-coated tablets
BAYER
PRINCIPAL DISPLAY PANEL- 20 mg Tablet Carton
10PRINCIPAL DISPLAY PANEL- 40 mg Tablet Carton
NDC 50419-542-01
Kerendia
30 film-coated tablets
BAYER
PRINCIPAL DISPLAY PANEL- 40 mg Tablet Carton