FDA Approves Drug to Reduce Risk of Serious Kidney and Heart Complications in Adults With Chronic Kidney Disease

The US Food and Drug Administration (FDA) has approved Kerendia™(finerenone) for adults with chronic kidney disease associated with type 2 diabetes. It is used to reduce the risk of:1

  • Reduced kidney function
  • Kidney failure
  • Death from heart disease
  • Non-fatal heart attacks
  • Hospital stays for heart failure

Diabetes is the main cause of chronic kidney disease and failure in the US. The approval of this drug means there is an effective treatment that can help reduce complications of chronic kidney disease from type 2 diabetes.

What are the ingredients in Kerendia (finerenone)?

The active ingredient in Kerendia is finerenone.2

How does Kerendia work?

Kerendia works by blocking an overactive receptor in the body (mineralocorticoid receptor). When this receptor is too active, fibrosis, inflammation, and kidney damage can occur. By blocking this receptor, Kerendia reduces the risk of kidney damage and disease.2

Evidence for Kerendia

A multicenter, randomized, double-blind, placebo-controlled study was performed. Participants (5,674 adults) had chronic kidney disease linked to type 2 diabetes. Participants were assigned to get either Kerendia or a pill that looked like a real drug, but did not contain medicine (placebo).1

The study compared the 2 groups to see the number of people whose disease progressed to a series of events, called endpoints. The study showed that those who took Kerendia had decreased rates of:1,2

  • Low kidney function
  • Kidney failure
  • Kidney death

The study also showed a decrease in the risk linked to heart disease. For those taking Kerendia, there was a decrease in:1

  • Death from heart disease
  • Non-fatal heart attack
  • Hospital stays for heart failure

What are the possible side effects?

Side effects seen of Kerendia include:1

  • High blood potassium levels
  • Low blood pressure
  • Low blood sodium levels

These are not all of the possible side effects of Kerendia. Talk with your doctor about what to expect, or if you experience any changes that concern you while taking Kerendia.

Things to know about Kerendia

Kerendia is a tablet that can be taken with or without food.

People with adrenal insufficiency and those taking drugs known as CYP3A4 inhibitors should not take Kerendia. Do not drink grapefruit juice or eat grapefruit while taking this drug. All of these things can increase the plasma concentration of Kerendia. Talk to your doctor before changing your diet or taking a new drug or herb.1,22

You may need blood tests while taking Kerendia to monitor your potassium and sodium levels.3

There is no available data for use of Kerendia in those who are pregnant. Talk with your doctor about the risks of taking this drug while pregnant. Kerendia has been found to be in animal milk. You should not breastfeed during treatment with Kerendia and for some time after the last dose.2

Before taking Kerendia, tell your doctor about all of your health conditions and any other drugs, vitamins, or supplements you are taking. This includes over-the-counter drugs.

For more information, read the full prescribing information of Kerendia.

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