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mechanism of action is Mineralocorticoid Receptor Antagonists [MoA]

Kerendia

(Finerenone)

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Dosage & Administration

* The recommended starting dosage is 10 mg or 20 mg orally once daily based on eGFR and serum potassium thresholds. (

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)].

)
* 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 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)
		Current Kerendia Dose
		10 mg once daily	20 mg once daily
Current Serum Potassium (mEq/L)	≤ 4.8	Increase the dose to 20 mg once daily.If eGFR has decreased by more than 30% compared to previous measurement, maintain 10 mg dose.	Maintain 20 mg once daily.
	> 4.8 – 5.5	Maintain 10 mg once daily.	Maintain 20 mg once daily.
	> 5.5	Withhold Kerendia. Consider restarting at 10 mg once daily when serum potassium ≤ 5.0 mEq/L.	Withhold Kerendia. Restart at 10 mg once daily when serum potassium ≤ 5.0 mEq/L.

Heart Failure with LVEF ≥ 40%

The target daily dose of Kerendia for heart failure (LVEF ≥ 40%) is dependent on renal function (eGFR) at initiation of Kerendia treatment (see Table 3).

The target daily dose is 40 mg orally once daily if eGFR at initiation is ≥ 60 mL/min/1.73m².

The target daily dose is 20 mg orally once daily if eGFR at initiation is ≥ 25 to < 60 mL/min/1.73m².

Measure serum potassium and eGFR 4 weeks after initiating treatment and adjust dose (see Table 3). Measure serum potassium and eGFR 4 weeks after a dose adjustment and monitor periodically throughout treatment, and adjust the dose as needed (see Table 3)

[see Warnings and Precautions (5.1& 5.2)and Drug Interactions (7.1)].

Table 3: Dose Adjustment Based on Current Serum Potassium Concentration, eGFR, and Current Dose (Heart Failure (LVEF ≥ 40%))
		Current Kerendia Dose
		10 mg once daily	20 mg once daily	40 mg once daily
Current Serum Potassium (mEq/L)	< 5.0	Increase the dose to 20 mg once dailyIf eGFR has decreased by more than 30% compared to previous measurement, maintain current dose.	Maintain 20 mg once daily if eGFR < 60 mL/min/1.73 m²at initiation. Otherwise increase the dose to 40 mg once daily	Maintain 40 mg once daily.
	≥ 5.0 to < 5.5	Maintain current dose.
	≥ 5.5 to < 6.0	Withhold Kerendia. Restart at 10 mg once daily when serum potassium < 5.5 mEq/L.	Decrease to 10 mg once daily.	Decrease to 20 mg once daily.
	≥ 6.0	Withhold Kerendia. Restart at 10 mg once daily when serum potassium < 5.5 mEq/L.If repeated serum potassium measurements are ≥5.5 mEq/L, restart Kerendia at 10 mg once daily when serum potassium < 5.0 mEq/L.

)
* 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 Monitoring and Dosage Adjustment

CKD associated with T2DM

The target daily dose of Kerendia is 20 mg orally.

[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)
		Current Kerendia Dose
		10 mg once daily	20 mg once daily
Current Serum Potassium (mEq/L)	≤ 4.8	Increase the dose to 20 mg once daily.If eGFR has decreased by more than 30% compared to previous measurement, maintain 10 mg dose.	Maintain 20 mg once daily.
	> 4.8 – 5.5	Maintain 10 mg once daily.	Maintain 20 mg once daily.
	> 5.5	Withhold Kerendia. Consider restarting at 10 mg once daily when serum potassium ≤ 5.0 mEq/L.	Withhold Kerendia. Restart at 10 mg once daily when serum potassium ≤ 5.0 mEq/L.

Heart Failure with LVEF ≥ 40%

The target daily dose of Kerendia for heart failure (LVEF ≥ 40%) is dependent on renal function (eGFR) at initiation of Kerendia treatment (see Table 3).

The target daily dose is 40 mg orally once daily if eGFR at initiation is ≥ 60 mL/min/1.73m².

The target daily dose is 20 mg orally once daily if eGFR at initiation is ≥ 25 to < 60 mL/min/1.73m².

[see Warnings and Precautions (5.1& 5.2)and Drug Interactions (7.1)].

Table 3: Dose Adjustment Based on Current Serum Potassium Concentration, eGFR, and Current Dose (Heart Failure (LVEF ≥ 40%))
		Current Kerendia Dose
		10 mg once daily	20 mg once daily	40 mg once daily
Current Serum Potassium (mEq/L)	< 5.0	Increase the dose to 20 mg once dailyIf eGFR has decreased by more than 30% compared to previous measurement, maintain current dose.	Maintain 20 mg once daily if eGFR < 60 mL/min/1.73 m²at initiation. Otherwise increase the dose to 40 mg once daily	Maintain 40 mg once daily.
	≥ 5.0 to < 5.5	Maintain current dose.
	≥ 5.5 to < 6.0	Withhold Kerendia. Restart at 10 mg once daily when serum potassium < 5.5 mEq/L.	Decrease to 10 mg once daily.	Decrease to 20 mg once daily.
	≥ 6.0	Withhold Kerendia. Restart at 10 mg once daily when serum potassium < 5.5 mEq/L.If repeated serum potassium measurements are ≥5.5 mEq/L, restart Kerendia at 10 mg once daily when serum potassium < 5.0 mEq/L.

)
* Tablets may be taken with or without food (

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/1.73m²)	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)]

)

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Kerendia Prescribing Information

Indications and 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).
cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adult patients with heart failure with left ventricular ejection fraction (LVEF) ≥ 40%

)

7/2025

Dosage and Administration (

2.3 Monitoring and Dosage Adjustment

CKD associated with T2DM

The target daily dose of Kerendia is 20 mg orally.

[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)
		Current Kerendia Dose
		10 mg once daily	20 mg once daily
Current Serum Potassium (mEq/L)	≤ 4.8	Increase the dose to 20 mg once daily.If eGFR has decreased by more than 30% compared to previous measurement, maintain 10 mg dose.	Maintain 20 mg once daily.
	> 4.8 – 5.5	Maintain 10 mg once daily.	Maintain 20 mg once daily.
	> 5.5	Withhold Kerendia. Consider restarting at 10 mg once daily when serum potassium ≤ 5.0 mEq/L.	Withhold Kerendia. Restart at 10 mg once daily when serum potassium ≤ 5.0 mEq/L.

Heart Failure with LVEF ≥ 40%

The target daily dose of Kerendia for heart failure (LVEF ≥ 40%) is dependent on renal function (eGFR) at initiation of Kerendia treatment (see Table 3).

The target daily dose is 40 mg orally once daily if eGFR at initiation is ≥ 60 mL/min/1.73m².
The target daily dose is 20 mg orally once daily if eGFR at initiation is ≥ 25 to < 60 mL/min/1.73m².

[see Warnings and Precautions (5.1& 5.2)and Drug Interactions (7.1)].

Table 3: Dose Adjustment Based on Current Serum Potassium Concentration, eGFR, and Current Dose (Heart Failure (LVEF ≥ 40%))
		Current Kerendia Dose
		10 mg once daily	20 mg once daily	40 mg once daily
Current Serum Potassium (mEq/L)	< 5.0	Increase the dose to 20 mg once dailyIf eGFR has decreased by more than 30% compared to previous measurement, maintain current dose.	Maintain 20 mg once daily if eGFR < 60 mL/min/1.73 m²at initiation. Otherwise increase the dose to 40 mg once daily	Maintain 40 mg once daily.
	≥ 5.0 to < 5.5	Maintain current dose.
	≥ 5.5 to < 6.0	Withhold Kerendia. Restart at 10 mg once daily when serum potassium < 5.5 mEq/L.	Decrease to 10 mg once daily.	Decrease to 20 mg once daily.
	≥ 6.0	Withhold Kerendia. Restart at 10 mg once daily when serum potassium < 5.5 mEq/L.If repeated serum potassium measurements are ≥5.5 mEq/L, restart Kerendia at 10 mg once daily when serum potassium < 5.0 mEq/L.

)

7/2025

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.
Patients with adrenal insufficiency.
Hypersensitivity to any component of this product.

)

7/2025

Warnings and Precautions (

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/1.73m²is 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 function.

)

7/2025

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%.

The recommended starting dosage is 10 mg or 20 mg orally once daily based on eGFR and serum potassium thresholds. (
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)].
)

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 Monitoring and Dosage Adjustment

CKD associated with T2DM

The target daily dose of Kerendia is 20 mg orally.

[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)
		Current Kerendia Dose
		10 mg once daily	20 mg once daily
Current Serum Potassium (mEq/L)	≤ 4.8	Increase the dose to 20 mg once daily.If eGFR has decreased by more than 30% compared to previous measurement, maintain 10 mg dose.	Maintain 20 mg once daily.
	> 4.8 – 5.5	Maintain 10 mg once daily.	Maintain 20 mg once daily.
	> 5.5	Withhold Kerendia. Consider restarting at 10 mg once daily when serum potassium ≤ 5.0 mEq/L.	Withhold Kerendia. Restart at 10 mg once daily when serum potassium ≤ 5.0 mEq/L.

Heart Failure with LVEF ≥ 40%

The target daily dose of Kerendia for heart failure (LVEF ≥ 40%) is dependent on renal function (eGFR) at initiation of Kerendia treatment (see Table 3).

The target daily dose is 40 mg orally once daily if eGFR at initiation is ≥ 60 mL/min/1.73m².
The target daily dose is 20 mg orally once daily if eGFR at initiation is ≥ 25 to < 60 mL/min/1.73m².

[see Warnings and Precautions (5.1& 5.2)and Drug Interactions (7.1)].

Table 3: Dose Adjustment Based on Current Serum Potassium Concentration, eGFR, and Current Dose (Heart Failure (LVEF ≥ 40%))
		Current Kerendia Dose
		10 mg once daily	20 mg once daily	40 mg once daily
Current Serum Potassium (mEq/L)	< 5.0	Increase the dose to 20 mg once dailyIf eGFR has decreased by more than 30% compared to previous measurement, maintain current dose.	Maintain 20 mg once daily if eGFR < 60 mL/min/1.73 m²at initiation. Otherwise increase the dose to 40 mg once daily	Maintain 40 mg once daily.
	≥ 5.0 to < 5.5	Maintain current dose.
	≥ 5.5 to < 6.0	Withhold Kerendia. Restart at 10 mg once daily when serum potassium < 5.5 mEq/L.	Decrease to 10 mg once daily.	Decrease to 20 mg once daily.
	≥ 6.0	Withhold Kerendia. Restart at 10 mg once daily when serum potassium < 5.5 mEq/L.If repeated serum potassium measurements are ≥5.5 mEq/L, restart Kerendia at 10 mg once daily when serum potassium < 5.0 mEq/L.

)

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 Monitoring and Dosage Adjustment

CKD associated with T2DM

The target daily dose of Kerendia is 20 mg orally.

[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)
		Current Kerendia Dose
		10 mg once daily	20 mg once daily
Current Serum Potassium (mEq/L)	≤ 4.8	Increase the dose to 20 mg once daily.If eGFR has decreased by more than 30% compared to previous measurement, maintain 10 mg dose.	Maintain 20 mg once daily.
	> 4.8 – 5.5	Maintain 10 mg once daily.	Maintain 20 mg once daily.
	> 5.5	Withhold Kerendia. Consider restarting at 10 mg once daily when serum potassium ≤ 5.0 mEq/L.	Withhold Kerendia. Restart at 10 mg once daily when serum potassium ≤ 5.0 mEq/L.

Heart Failure with LVEF ≥ 40%

The target daily dose of Kerendia for heart failure (LVEF ≥ 40%) is dependent on renal function (eGFR) at initiation of Kerendia treatment (see Table 3).

The target daily dose is 40 mg orally once daily if eGFR at initiation is ≥ 60 mL/min/1.73m².
The target daily dose is 20 mg orally once daily if eGFR at initiation is ≥ 25 to < 60 mL/min/1.73m².

[see Warnings and Precautions (5.1& 5.2)and Drug Interactions (7.1)].

Table 3: Dose Adjustment Based on Current Serum Potassium Concentration, eGFR, and Current Dose (Heart Failure (LVEF ≥ 40%))
		Current Kerendia Dose
		10 mg once daily	20 mg once daily	40 mg once daily
Current Serum Potassium (mEq/L)	< 5.0	Increase the dose to 20 mg once dailyIf eGFR has decreased by more than 30% compared to previous measurement, maintain current dose.	Maintain 20 mg once daily if eGFR < 60 mL/min/1.73 m²at initiation. Otherwise increase the dose to 40 mg once daily	Maintain 40 mg once daily.
	≥ 5.0 to < 5.5	Maintain current dose.
	≥ 5.5 to < 6.0	Withhold Kerendia. Restart at 10 mg once daily when serum potassium < 5.5 mEq/L.	Decrease to 10 mg once daily.	Decrease to 20 mg once daily.
	≥ 6.0	Withhold Kerendia. Restart at 10 mg once daily when serum potassium < 5.5 mEq/L.If repeated serum potassium measurements are ≥5.5 mEq/L, restart Kerendia at 10 mg once daily when serum potassium < 5.0 mEq/L.

)

Tablets may be taken with or without food (
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/1.73m²) 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)]
.
)

Lactation: Breastfeeding not recommended (

8.2 Lactation

Risk Summary

There are no data on the presence of finerenone or its metabolite in human milk, the effects on the breastfed infant or the effects of the drug on milk production. In a pre- and postnatal developmental toxicity study in rats, increased pup mortality and lower pup weight were observed at about 2 times the AUC_unboundexpected in humans. These findings suggest that finerenone is present in rat milk

[see Use in Specific Populations (8.1)and Data].

When a drug is present in animal milk, it is likely that the drug will be present in human milk. Because of the potential risk to breastfed infants from exposure to Kerendia, avoid breastfeeding during treatment and for 1 day after treatment.

)

Kerendia is contraindicated in patients:

Who are hypersensitive to any component of this product
[see
6.2 Postmarketing 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
]
.
Who are receiving concomitant treatment with strong CYP3A4 inhibitors
[see
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.
].
With adrenal insufficiency.

Kerendia

Dosage & Administration

Kerendia Prescribing Information

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