Kerendia

Kerendia (finerenone) is an FDA-approved medicine used for heart failure or chronic kidney disease (from type 1 diabetes or type 2 diabetes) in certain patients. In kidney disease with type 2 diabetes, Kerendia slows kidney damage and lowers the risk of kidney failure, cardiovascular death, heart attack, and being hospitalized for heart failure. In type 1 diabetes, Kerendia lowers protein in the urine, which is expected to slow the progression of kidney disease. In heart failure, it lowers the risk of cardiovascular death and heart failure hospital visits.

Kerendia is from the class of medicines called mineralocorticoid receptor antagonists.

Chronic kidney disease (CKD) is when your kidneys don't work properly and become less effective over time. Having type 1 diabetes or type 2 diabetes increases your chances of having chronic kidney disease. Often, diabetics do not have any symptoms in the early stages of CKD, and they might not realize they have it until it is advanced; they may need to have dialysis or a kidney transplant to survive. If you have diabetes, it is important to get your kidneys checked regularly by having a blood and urine test. If you have signs of reduced kidney function or the start of CKD, early treatment can help prevent you from having extra health problems.

When you have CKD, you have health problems from fluid, electrolytes (minerals required for many bodily processes), and waste building up in the body. If you have CKD, you are also at high risk of heart disease.

Kerendia is FDA-approved for adults with:

• Chronic kidney disease (CKD) associated with type 2 diabetes, to reduce the risk of ongoing loss of kidney function (sustained eGFR decline), end-stage kidney disease, cardiovascular death, non-fatal heart attack, and hospitalization for heart failure. (10 mg and 20 mg tablets)
• Chronic kidney disease (CKD) associated with type 1 diabetes, to reduce the amount of albumin (a protein) in the urine, measured as the urinary albumin-to-creatinine ratio, or UACR. Lowering UACR is expected to reduce the risk of sustained eGFR decline and end-stage kidney disease. (10 mg and 20 mg tablets)
• Heart failure with a left ventricular ejection fraction (LVEF) of 40% or higher, to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits. (10 mg, 20 mg, and 40 mg tablets)

One of the reasons CKD can get worse in diabetes is due to inflammation and scarring of the kidneys.

How Kerendia is thought to work is:

• There is a receptor in the kidneys, heart, and blood vessel tissues that is called the mineralocorticoid receptor (MR).
• When MR is overactive, it leads to inflammation, tissue damage, and scarring, which is thought to cause kidney disease and cardiovascular disease to become worse.
• Kerendia blocks the MR so that it is not as active, so the MR is less likely to cause as much inflammation and damage to the kidneys, blood vessels, and heart.
• In studies of people with CKD associated with type 2 diabetes, and in people with heart failure, this reduced the risk of cardiovascular death, heart attack, and hospitalization for heart failure. In people with CKD associated with type 1 diabetes, Kerendia lowered protein in the urine, which is expected to slow kidney disease from getting worse.

Kerendia's mechanism of action is as a non-steroidal mineralocorticoid receptor antagonist (nsMRA) that selectively and potently blocks mineralocorticoid receptor overactivation in the heart and kidneys.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may take finerenone with or without food.

If you cannot swallow a tablet whole, crush the tablet and mix it with water or soft food such as applesauce. Swallow the mixture right away.

You will need medical tests.

Do not take potassium supplements or use salt substitutes, unless your doctor has told you to.

Grapefruit may interact with finerenone and cause side effects. Avoid grapefruit and grapefruit juice while taking Kerendia.

You should not use Kerendia if you:

• are allergic to finerenone or any ingredient in Kerendia
• have adrenal insufficiency, which means your adrenal glands do not make enough hormones
• take a medicine that is a strong CYP3A4 inhibitor

Strong CYP3A4 inhibitors must not be taken with Kerendia. These include:

• nefazodone
• the antibiotic clarithromycin
• antifungal medicines such as itraconazole, ketoconazole, posaconazole, and voriconazole
• antiviral medicines for HIV or hepatitis C such as cobicistat, lopinavir/ritonavir, ritonavir, saquinavir, and tipranavir

Ask your healthcare provider if you are not sure whether any of your medicines is a strong CYP3A4 inhibitor.

Tell your doctor if you have ever had:

• severe liver disease; or
• high blood levels of potassium (hyperkalemia).

It is not known if finerenone will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

You should not breastfeed while using finerenone, and for at least 1 day after your last dose.

Not approved for use by anyone younger than 18 years old.

Get emergency medical help if you have signs of an allergic reaction to Kerendia: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Treatment with Kerendia may cause serious side effects. Call your doctor at once if you have:

• high blood potassium: nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement;
• low blood sodium: headache, confusion, problems with thinking or memory, weakness, feeling unsteady; or
• worsening of kidney function (especially if you have heart failure).

Common Kerendia side effects may include:

• high potassium;
• low sodium; or
• low blood pressure.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Kerendia tablets may be taken with or without food.

Serum potassium and eGFR are measured before treatment starts. Kerendia is not started if serum potassium is above 5.0 mEq/L.

The starting dose is 10 mg or 20 mg once a day, based on eGFR:

• eGFR at least 60 mL/min/1.73 m2: 20 mg once a day
• eGFR 25 to less than 60 mL/min/1.73 m2: 10 mg once a day
• eGFR less than 25 mL/min/1.73 m2: starting Kerendia is not recommended

After 4 weeks, the dose is increased to the target dose, depending on eGFR and serum potassium:

• CKD associated with type 1 or type 2 diabetes: target dose 20 mg once a day
• Heart failure with LVEF ≥ 40%: target dose 20 mg or 40 mg once a day, depending on eGFR when treatment started

Serum potassium is checked 4 weeks after starting, 4 weeks after any dose change, and periodically during treatment. The dose may be increased, reduced, or paused based on the result. See the detailed dosage instructions for the potassium thresholds.

Dosage forms

Kerendia comes as film-coated oblong tablets in three strengths: 10 mg (pink, marked FI and 10), 20 mg (yellow, marked FI and 20), and 40 mg (gray-orange, marked FI and 40).

Take the missed dose on the same day you remember it. Take your next dose at the regular time and stay on your once-daily schedule. Do not take 2 doses in one day.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Many drugs can affect Kerendia, and some drugs must not be used at the same time. Tell your doctor or pharmacist about all other medicines you use. This includes prescription and over-the-counter medicines, vitamins, and herbal products.

Strong CYP3A4 inhibitors must not be taken with Kerendia. These include nefazodone, clarithromycin, itraconazole, ketoconazole, posaconazole, voriconazole, ritonavir, lopinavir/ritonavir, and cobicistat. Taking them together raises finerenone levels in the blood.

Grapefruit and grapefruit juice should be avoided during treatment, because they affect the same enzyme and can raise finerenone levels.

Moderate and weak CYP3A4 inhibitors such as amiodarone, erythromycin, fluconazole, diltiazem, verapamil, and conivaptan should only be used under medical supervision. Your potassium level will be checked when you start or change either medicine, and your Kerendia dose may be adjusted.

Strong and moderate CYP3A4 inducers should be avoided during treatment with Kerendia.

Sensitive CYP2C8 substrates need closer monitoring for side effects if you are taking Kerendia 40 mg a day.

Not all possible interactions are listed here; use the link below to check for other Kerendia drug interactions.

Store Kerendia at room temperature between 68°F and 77°F (20°C to 25°C).

Active ingredient: finerenone

Inactive ingredients: 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).