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Effective Medicine for treating CKD in T2D-Kerendia Finerenone

Kerendia Finerenone is a medication used in the treatment of certain medical conditions, specifically to address cardiovascular and kidney-related issues. It belongs to a class of drugs known as nonsteroidal mineralocorticoid receptor antagonists.

KERENDIA is a prescription medicine used to treat chronic kidney disease in adults with type 2 diabetes to reduce the risk of:

*Worsening of kidney disease
*Kidney failure
*Death due to cardiovascular disease
*Heart attack
*Hospitalization for heart failure

Kerendia Finerenone

What does Kerendia Finerenone do?

Key uses of Kerendia (Finerenone) include:

1.Chronic Kidney Disease (CKD) in Type 2 Diabetes

Kerendia is prescribed to reduce the risk of kidney disease progression, end-stage kidney disease, cardiovascular events, and hospitalization for heart failure in adults with chronic kidney disease associated with type 2 diabetes.

2.Mineralocorticoid Receptor Antagonist (MRA)

Kerendia works as a mineralocorticoid receptor antagonist, meaning it blocks the effects of certain hormones (such as aldosterone) that can contribute to kidney and cardiovascular issues.

3.Cardiorenal Protection

The medication provides cardiorenal protection by addressing both heart and kidney health. It is particularly beneficial for individuals with diabetes who are at an increased risk of developing complications affecting both organs.

4.Risk Reduction for Cardiovascular Events

In addition to its effects on kidney function, Kerendia is prescribed to reduce the risk of cardiovascular events, including heart failure, in patients with chronic kidney disease associated with type 2 diabetes.

kidney disease

Basic information about Kerendia Finerenone

1.INDICATIONS AND USAGE

Kerendia is indicated to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, nonfatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D).

2.DOSAGE AND ADMINISTRATION

2.1 Prior to Initiation of Kerendia

Measure serum potassium levels and estimated glomerular filtration rate (eGFR) before initiation. Do not initiate treatment if serum potassium is > 5.0 mEq/L.

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
≥ 6020 mg once daily
≥ 25 to < 6010 mg once daily
< 25Initiation is not recommended
Table 1: Recommended Starting Dosage

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.

2.3 Monitoring and Dose Adjustment

The target daily dose of Kerendia is 20 mg.

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. Monitor serum potassium 4 weeks after a dose adjustment and throughout treatment, and adjust the dose as needed (see Table 2).

Table 2: Dose Adjustment Based on Current Serum Potassium Concentration and Current Dose

Current Kerendia Dose
 10 mg once daily20 mg once daily
Current Serum Potassium (mEq/L)≤ 4.8Increase the dose to 20 mg once daily.*Maintain 20 mg once daily.
 > 4.8–5.5Maintain 10 mg once daily.Maintain 20 mg once daily.
 > 5.5Withhold Kerendia. Consider restarting at 10 mg once daily when serum potassium ≤ 5.0 mEq/L.Withhold Kerendia. Restart at 10 mg once daily whenserum potassium ≤ 5.0 mEq/L.
Table 2: Dose Adjustment Based on Current Serum Potassium Concentration and Current Dose

2.4 Missed doses

Direct a patient to take a missed dose as soon as possible after it is noticed, but only on the same day. If this is not possible, the patient should skip the dose and continue with the next dose as prescribed.

3.DOSAGE FORMS AND STRENGTHS

Kerendia is available as film-coated, oblong tablets in two 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.

4.CONTRAINDICATIONS

Kerendia is contraindicated in patients:

• Who are receiving concomitant treatment with strong CYP3A4 inhibitors.

• With adrenal insufficiency.

5.WARNINGS AND PRECAUTIONS

5.1 Hyperkalemia

Kerendia can cause hyperkalemia.

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. Do not initiate Kerendia if serum potassium is > 5.0 mEq/L. Measure serum potassium periodically during treatment with Kerendia and adjust dose accordingly. 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.

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6.ADVERSE REACTIONS

The following serious adverse reactions are discussed elsewhere in the labeling:

• Hyperkalemia

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.

The safety of Kerendia 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 in both studies was hyperkalemia. 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 3 shows adverse reactions that occurred more commonly on Kerendia than on placebo, and in at least 1% of patients treated with Kerendia.

Table 3: Adverse reactions reported in≥1% of patients on Kerendia and more frequently than placebo (Pooled data from FIDELIO-DKD and FIGARO-DKD).

Adverse reactionsKerendia N = 6510 n (%)Placebo N = 6489 n (%)
Hyperkalemia912 (14.0)448 (6.9)
Hypotension302 (4.6)194 (3.9)
Hyponatremia82 (1.3)47 (0.7)
Table 3: Adverse reactions reported in≥1% of patients on Kerendia and more frequently than placebo (Pooled data from FIDELIO-DKD and FIGARO-DKD).

Initiation of Kerendia may cause an initial small decrease in eGFR that occurs within the first 4 weeks of starting therapy, and then stabilizes. In a study that included patients with chronic kidney disease associated with type 2 diabetes, this decrease was reversible after treatment discontinuation.

Initiation of Kerendia may also cause a small increase in serum uric acid. This increase appears to attenuate over time.

7.DRUG INTERACTIONS

7.1 CYP3A4 Inhibitors and Inducers

Strong CYP3A4 Inhibitors Kerendia is a CYP3A4 substrate. Concomitant use with a strong CYP3A4 inhibitor increases finerenone exposure, which may increase the risk of Kerendia adverse reactions. Concomitant use of Kerendia with strong CYP3A4 inhibitors is contraindicated. 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, 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.

Strong and Moderate CYP3A4 Inducers

Kerendia is a CYP3A4 substrate. Concomitant use of Kerendia with a strong or moderate CYP3A4 inducer decreases

finerenone exposure, which may reduce the efficacy of Kerendia. Avoid concomitant use of Kerendia with strong or moderate CYP3A4 inducers.

7.2 Drugs That Affect Serum Potassium

More frequent serum potassium monitoring is warranted in patients receiving concomitant therapy with drugs or supplements that increase serum potassium.

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8.USE IN SPECIFIC POPULATIONS

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 4 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.

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 4 times the AUCunbound expected in humans. These findings suggest that finerenone is present in rat milk. 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.

8.4 Pediatric Use

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

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. No overall differences in safety or efficacy were observed between these patients and younger patients. No dose adjustment is required.

8.6 Hepatic Impairment

Avoid use of Kerendia in patients with severe hepatic impairment (Child Pugh C).

No dosage adjustment is recommended in patients with mild or moderate hepatic impairment (Child Pugh A or B). Consider additional serum potassium monitoring in patients with moderate hepatic impairment (Child Pugh B).

9.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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Kerendia Finerenone User Guide

KERENDIA slows the progression of kidney damage in adults with chronic kidney disease in type 2 diabetes.

Do not take KERENDIA if you:

• Have problems with your adrenal glands

• Take certain medications called CYP3A4 inhibitors. Ask your healthcare provider if you are not sure if you are taking any of these medications.

Before you take KERENDIA, tell your healthcare provider about all your medical conditions, including if you:

• Have high potassium levels in your blood (hyperkalemia) or take medications that may increase potassium levels in your blood. KERENDIA can cause hyperkalemia. Your healthcare provider will check your potassium levels before and during treatment with KERENDIA

• Have severe liver problems

• Are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. Avoid breastfeeding during treatment with KERENDIA and 1 day after treatment.

How do you get started on KERENDIA?

First, talk to your doctor about KERENDIA. If you and your doctor decide that KERENDIA is right for you, you will be prescribed KERENDIA to help slow the progression of your CKD in T2D. Before starting you on KERENDIA, your doctor will check the potassium levels in your blood and do an eGFR test to check your kidney function. After starting KERENDIA, your doctor will recheck your potassium levels and may adjust your dose.

KERENDIA is a tablet you take once a day, with or without food. You should swallow the tablet whole, but if you can’t, you can crush the tablet and mix it with water or soft foods. Avoid eating grapefruit or drinking grapefruit juice for as long as you are being treated with KERENDIA, as it may increase KERENDIA levels in the blood.

If you miss a dose of KERENDIA, take your prescribed dose as soon as you remember before the next scheduled dose. However, do not take 2 doses on the same day to make up for a missed dose.

Take KERENDIA as prescribed by your doctor. If you don’t remember how to take KERENDIA, check with your doctor or pharmacist.

Side Effects of Kerendia Finerenone

The most common side effects of KERENDIA include:

• Hyperkalemia (potassium level in your blood that is higher than normal)

• Hypotension (blood pressure that is lower than normal)

• Hyponatremia (sodium level in your blood that is lower than normal)

To understand how KERENDIA works, it helps to understand why chronic kidney disease in type 2 diabetes (CKD in T2D) may continue to progress over time. There are three main factors that contribute to the progression of CKD:

• Poorly controlled glucose

• Poorly controlled blood pressure

• Inflammation and scarring in the kidneys

While diabetes and high blood pressure medications may help control your glucose and blood pressure, KERENDIA is the only medication of its kind that blocks mineralocorticoid receptor (MR) overactivation in the kidneys, heart, and blood vessels. This is important because MR overactivation may contribute to inflammation and scarring that can lead to progression of kidney disease. This may also worsen your cardiovascular disease. Blocking MRs is thought to slow the progression of CKD in T2D. So even if you are already taking medications for your diabetes and high blood pressure, there may be more that you can do to help delay the kidney damage from CKD.

kerendia Finerenone price and why it is expensive

Kerendia (finerenone) is a member of the aldosterone receptor antagonists drug class and is commonly used for Chronic Kidney Disease.

The cost for Kerendia oral tablet 10 mg is around $670 for a supply of 30 tablets, $1990 for a supply of 90 tablets, depending on the pharmacy you visit.

Kerendia (finerenone) is a member of the aldosterone receptor antagonists drug class and is commonly used for Chronic Kidney Disease.
The cost for Kerendia oral tablet 10 mg is around $670 for a supply of 30 tablets, $1990 for a supply of 90 tablets, depending on the pharmacy you visit.

10 mg
Kerendia oral tablet
QuantityPer unitPrice
30$22.35$670.36
90$22.13$1992.09
20 mg
Kerendia oral tablet
QuantityPer unitPrice
30$22.35$670.36
90$22.13$1992.09

Why is Kerendia so expensive?

The pricing of Kerendia (Finerenone) and the cost of pharmaceuticals, in general, can be influenced by several factors. Here are some reasons why Kerendia might be relatively expensive:

Research and Development Costs: Pharmaceutical companies invest significantly in research and development to discover and bring new drugs to market. These costs, including clinical trials and regulatory approvals, contribute to the overall expense.

Patent Protection: Pharmaceutical companies often have exclusive patent rights for a certain period, allowing them to be the sole provider of a particular drug. During this time, they can set prices higher to recoup development costs.

Manufacturing Costs: The production of pharmaceuticals involves complex processes and quality control measures, which can contribute to higher manufacturing costs.

Demand and Supply Dynamics: If there is a high demand for a specific medication and limited competition, pharmaceutical companies may set prices at higher levels.

Continued Research and Innovation: Some of the revenue generated from drug sales is often reinvested in ongoing research and development for new medications.

Kerendia Finerenone

What can you take instead of Kerendia?

LUCIFINE Finerenone

LUCIFINE Finerenone Tablets Is a non-steroidal mineralocorticoid receptor antagonist (MRA) indicated to reduce the risk of sustained eGFR decline end stage kidney disease, cardiovascular death non-fatal myocardial infarction, and hospitalization for hear failure in adult patients with chronic kidney disease(CKD) associated with type 2 diabetes T2D).

Can Lucifine Finerenone Tablets Treat Diabetic Kidney Disease?

On October 26, 2020, Bayer held a global media briefing during the American Society of Nephrology’s 2020 Kidney Week to present the results of the FIDELIO-DKD Phase III clinical study for the investigational drug Finerenone. This presentation focused on the significant risks associated with the co-occurrence of chronic kidney disease and type 2 diabetes, shedding light on the latest findings from the FIDELIO-DKD Phase III clinical trial.

Dr. Richard Nkulikiyinka, the Clinical Development Head for Cardiology and Nephrology at Bayer in Germany, introduced Finerenone as an investigational, novel, non-steroidal, selective mineralocorticoid receptor antagonist (MRA). Research has shown that it can prevent various damages caused by the excessive activation of the mineralocorticoid receptor. The overactivation of this receptor leads to inflammation and fibrosis, which are significant factors in the damage to the kidneys and cardiovascular system.

Finerenone was discovered after screening over a million compounds, and it differs from existing mineralocorticoid receptor antagonists in that it is fundamentally non-steroidal, often referred to as a non-steroidal mineralocorticoid receptor antagonist. Extensive animal studies have shown its effective anti-inflammatory and anti-fibrotic properties in both the kidneys and the heart. Moreover, Phase II clinical trial ARTS-DN demonstrated that it can improve a patient’s proteinuria without being influenced by blood pressure. Hence, when conducting the FIDELIO-DKD clinical study, it was assumed that the MR antagonistic action of this drug would slow the progression of kidney disease in chronic kidney disease and type 2 diabetes patients while reducing the incidence of cardiovascular disease and mortality.

LUCIFINE finerenone tablets

Semaglutide Tablets RYBELSUS®

Semaglutide tablets are a type of medication used to treat type 2 diabetes. They belong to a class of drugs known as glucagon-like peptide-1 (GLP-1) receptor agonists. Semaglutide works by mimicking the effects of a naturally occurring hormone called GLP-1, which helps regulate blood sugar levels.

GLP-1 receptor agonists like semaglutide stimulate the release of insulin from the pancreas and reduce the amount of glucose produced by the liver. Additionally, they slow down the rate at which food is absorbed in the stomach, leading to a decrease in post-meal blood sugar levels. This class of medications also helps in promoting a feeling of fullness, which can contribute to weight loss.

Semaglutide is often prescribed to people with type 2 diabetes when lifestyle changes and other medications have not effectively controlled blood sugar levels.

Weight Management: In addition to its use in diabetes, Semaglutide has also been found to be effective in weight management. It can help reduce body weight in individuals when used alongside a reduced-calorie diet and increased physical activity.

Semaglutide Tablets

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References: https://www.kerendia-us.com/pi