FDA Approves Kerendia for Chronic Kidney Disease in People With Diabetes
Key takeaways:
In July 2021, the FDA approved Bayer’s Kerendia (finerenone) to treat chronic kidney disease (CKD) in people with type 2 diabetes.
Kerendia is the first medication in its class — mineralocorticoid receptor antagonists — to be FDA-approved for CKD.
Kerendia has few side effects and can cause high blood potassium in some people. You’ll need to have regular blood tests done to watch for this.
The kidneys are two very important organs in our bodies. They filter our blood to help get rid of waste and extra fluid while holding onto electrolytes and minerals our other organs need to function properly. They also help control blood pressure and produce red blood cells. But for about 37 million U.S. adults, their kidneys aren’t working the way they should on a daily basis — a condition known as chronic kidney disease (CKD).
Many people with CKD take medications to help prevent their condition from worsening. Among them are people with type 2 diabetes, a condition that greatly raises the risk of developing CKD. Recently, the FDA approved a new medication for CKD associated with diabetes — Kerendia (finerenone). This medication is the first in its class approved for this condition.
Here, we’ll discuss what Kerendia is, how it works, and what to expect if you take this medication.
What is CKD?
Before we go into detail about Kerendia, let’s first discuss what it treats. CKD is a chronic condition in which the kidneys have been damaged and aren’t working as well as they should. It’s considered a progressive condition, meaning it typically gets worse with time and usually cannot be reversed with medications.
CKD is split into five stages, depending on how well your kidneys are working. Stage 1 is the mildest form of CKD, while stage 5 represents kidney failure. Many people experience no symptoms until they have more severe forms of the condition.
In more severe stages, CKD can cause symptoms, such as:
Changes to how much urine you make
Trouble breathing
Swelling (edema) in the hands, legs, ankles, or feet
Feeling tired
While your risk of CKD goes up as you get older, other health conditions — like diabetes, high blood pressure, and lupus — can raise this risk even further. CKD can also stem from damage caused by other medications, especially if they are taken long-term.
Why does diabetes raise your risk of CKD?
Diabetes is the leading cause of CKD, affecting one third of adults with diabetes. Over time, high amounts of sugar in your blood damages several organs, including the kidneys. The longer your blood sugar is too high, the more likely you are to develop CKD.
This risk rises even further if you also have high blood pressure, heart disease, excess body weight, or you smoke. If you have diabetes, the best way to lower your risk of developing CKD or prevent the condition from getting worse is by doing your best to keep your blood sugars within the goal range you and your provider have discussed.
What problems can CKD cause?
Because your kidneys remove extra fluid from your bloodstream, people with CKD can end up with too much fluid in their bloodstream. This puts stress on the heart, as it has to work harder to pump that extra fluid.
This is why people with CKD are at a higher risk for developing heart-related problems, such as:
High blood pressure
Heart disease
Lower numbers of red blood cells (anemia)
CKD also raises your risk of having a heart attack or stroke. By slowing the progression of the condition and preventing kidney-related complications, many CKD medications can also help prevent heart-related problems.
What is Kerendia?
Kerendia is a once-daily oral tablet that belongs to a class of medications known as mineralocorticoid receptor antagonists (MRAs), also called aldosterone antagonists. Unlike the other two medications in this class — spironolactone and eplerenone— Kerendia is not steroid-based. This means it both treats different conditions and has fewer side effects than the other MRAs.
Kerendia is the first MRA to be approved for CKD. This medication is FDA-approved to treat CKD associated with type 2 diabetes and helps with the following:
Slowing how quickly a person’s CKD worsens
Lowering the risk of developing end-stage CKD (when your kidneys stop working after entering stage 5 CKD)
Lowering your risk of dying from heart-related problems
Lowering your risk of heart attacks
Lowering your risk of hospital stays due to heart failure (a heart condition people with diabetes are more likely to develop)
How does Kerendia work to prevent CKD complications?
With these potential benefits, you might be wondering how one medication can do all this. Kerendia works by blocking aldosterone in certain areas of the kidneys, heart, and blood vessels.
Aldosterone is a hormone that helps regulate blood pressure and blood levels of sodium and potassium. People with heart disease, high blood pressure, and CKD sometimes have higher levels of this hormone than people without these conditions.
When there’s too much aldosterone in the body, it can cause inflammation (swelling) and fibrosis (scar tissue) in the kidneys, heart, and blood vessels. Over time, this can cause kidney damage, heart problems, and a hardening of the blood vessels (atherosclerosis).
Kerendia stops aldosterone from being able to bind to these areas of the body, helping prevent the damage it causes. This, in turn, helps prevent the CKD complications listed above.
What are the risks and side effects of Kerendia?
In clinical trials, people taking Kerendia experienced few side effects. The most commonly reported side effect was high blood potassium. Some people also experienced low blood pressure and low blood sodium.
As with other MRAs, Kerendia can cause your body to hold on to more potassium. People with CKD and diabetes are more likely to have higher levels of potassium than those without these conditions. Because of this, Kerendia can lead to blood potassium levels that are too high.
High potassium can be dangerous. It can cause muscle problems, heart rhythm problems (arrhythmias), and cardiac arrest. Because of this risk, you should have regular blood tests to watch your potassium levels while taking Kerendia. Going for these tests on time will help catch high potassium before it becomes dangerous.
What are the known drug interactions of Kerendia?
Like all medications, Kerendia has drug interactions to be aware of. You should avoid eating grapefruit or drinking grapefruit juice, as it raises your risk of side effects with Kerendia.
Medications known as CYP3A4 inhibitors also raise your risk of side effects with Kerendia. Commonly prescribed CYP3A4 inhibitors include clarithromycin (Biaxin), ketoconazole, fluconazole (Diflucan), and diltiazem (Cardizem). Ask your pharmacist if any other medications you take are CYP3A4 inhibitors, and discuss this interaction with your provider.
Medications known as CYP3A4 inducers could make Kerendia less effective. Common CYP3A4 inducers include phenobarbital, phenytoin (Dilantin), carbamazepine (Tegretol), and the herbal medication St. John’s Wort. Be sure to ask your pharmacist if any other medications you take are CYP3A4 inducers.
Taking other medications that can raise your potassium levels — such as angiotensin-converting enzymes (ACE) inhibitors, angiotensin II receptor blockers (ARBs), and nonsteroidal anti-inflammatory drugs (NSAIDs) — could also be problematic while taking Kerendia.
Taking these together can raise your risk for high potassium levels. While you may still be able to combine these types of medications, your provider may ask you to have more frequent blood tests done to watch your potassium levels.
This is not a complete list of all drug interactions. Be sure to provide an updated list of all your medications, vitamins, and supplements to your healthcare provider and pharmacist before starting Kerendia.
How much will Kerendia cost?
Information on Kerendia’s retail cost is not available yet. Typically, pricing information isn’t released until a medication is launched and available in pharmacies.
However, because it’s a brand-name medication, we expect it to be more expensive. As always, GoodRx will have coupons available to help with the cost of Kerendia when the medication has officially launched.
Bayer — the manufacturer of Kerendia — already has a copay savings card available on their website. For those that qualify, they can save up to $3,000 per year on Kerendia. This card can be combined with commercial insurance and may lower the cost to you down to $10 per month. Check and see if you’re eligible here.
When will Kerendia be available?
You don’t have to wait too long for Kerendia to be in pharmacies. It’s expected to be available by the end of July 2021. This is a great time to talk to your healthcare provider and see if Kerendia is an option for treating your CKD.
The bottom line
Kerendia is a new medication recently FDA-approved to treat CKD in people with type 2 diabetes. It’s the first medication in its class — aldosterone antagonists — to be approved for this condition. Kerendia doesn’t have many known side effects, but it does require you to have regular blood tests done to watch for high potassium levels.
Kerendia will be available soon, so be sure to speak with your provider about whether you may benefit from this medication.
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References
Agarwal, R., et al. (2020). Steroidal and non-steroidal mineralocorticoid receptor antagonists in cardiorenal medicine. European Heart Journal.
American Heart Association News. (2019). Diabetes and heart failure are linked; Treatment should be too. American Heart Association.
American Heart Association. (2020). What is atherosclerosis?.
Bayer Healthcare Pharmaceuticals Inc. (2021). Kerendia [package insert].
Bayer. (2021). Bayer’s KERENDIA® (finerenone) receives U.S. FDA approval for treatment of patients with chronic kidney disease associated with type 2 diabetes.
Ben Salem, C., et al. (2014). Drug-induced hyperkalemia. Drug Safety.
Centers for Disease Control and Prevention. (2022). Chronic kidney disease basics.
Kerendia. (n.d.). Eligibility for patients.
Kerendia. (n.d.). Welcome to the KERENDIA Savings Program.
Kolkhof, P., et al. (2017). Steroidal and novel non-steroidal mineralocorticoid receptor antagonists in heart failure and cardiorenal diseases: Comparison at bench and bedside. Handbook of Experimental Pharmacology.
Minakuchi, H., et al. (2020). The effect of aldosterone and aldosterone blockade on the progression of chronic kidney disease: A randomized placebo-controlled clinical trial. Scientific Reports.
National Institute of Diabetes and Digestive and Kidney Diseases. (n.d.). Chronic kidney disease (CKD).
National Institute of Diabetes and Digestive and Kidney Diseases. (2016). Causes of chronic kidney disease.
National Institute of Diabetes and Digestive and Kidney Diseases. (2017). Diabetic kidney disease.
National Institute of Diabetes and Digestive and Kidney Diseases. (2017). What is chronic kidney disease?.
National Kidney Foundation. (n.d.). Estimated glomerular filtration rate (eGFR).
Rakugi, H., et al. (2021). Management of hyperkalemia during treatment with mineralocorticoid receptor blockers: Findings from esaxerenone. Hypertension Research.
Scott, J. H., et al. (2022). Physiology, aldosterone. StatPearls.
Simon, L. V., et al. (2022). Hyperkalemia. StatPearls.
Smith, L. (2020). Chronic kidney disease + Your heart: What’s the connection?. HealthiNation from GoodRx.
Smith, L. (2020). How is chronic kidney disease treated to prevent heart complications?. HealthiNation from GoodRx.
U.S. Food and Drug Administration. (2021). FDA approves drug to reduce risk of serious kidney and heart complications in adults with chronic kidney disease associated with type 2 diabetes.
