Finerenone is used in adults with chronic kidney disease related to diabetes mellitus type 2, to reduce the risk of:

• kidney problems getting worse;

• a heart attack;

• needing to be hospitalized for heart failure; or

• death from heart failure.

Finerenone may also be used for purposes not listed in this medication guide.

Tell your doctor about all your other medicines. Some drugs should not be used with finerenone.

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.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Chronic Kidney Disease:

Initial dose:
-For estimated glomerular filtration rate (eGFR) at least 60 mL/min/1.73 m2: 20 mg orally once a day
-For eGFR 25 to less than 60 mL/min/1.73 m2: 10 mg orally once a day
Target dose: 20 mg orally once a day

Comments:
-Initiation of therapy is not recommended if serum potassium is greater than 5 mEq/L; if serum potassium levels are greater than 4.8 to 5 mEq/L, initiation of therapy may be considered with additional serum potassium monitoring within the first 4 weeks based on clinical judgment and serum potassium levels.
-Initiation of therapy is not recommended in patients with eGFR less than 25 mL/min/1.73 m2.

Use: To reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, nonfatal myocardial infarction, and hospitalization for heart failure in patients with chronic kidney disease associated with type 2 diabetes

You should not use finerenone if you are allergic to it, or if you have problems with your adrenal gland.

Some drugs should not be used with finerenone. Your treatment plan may change if you also use:

• nefazodone;

• an antibiotic--clarithromycin, telithromycin;

• antifungal medicine--itraconazole, ketoconazole, posaconazole, voriconazole; or

• antiviral medicine for HIV or hepatitis C--boceprevir, cobicistat, dasabuvir, elvitegravir, indinavir, lopinavir/ritonavir, nelfinavir, ombitasvir, paritaprevir saquinavir, telaprevir, tipranavir.

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.

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.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Do not eat grapefruit or drink grapefruit juice while taking this medication.

Talk to your doctor before using potassium-containing salt substitutes while you are taking this medication.

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 consuming grapefruit products.

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

Finerenone 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; or

• low blood sodium--headache, confusion, problems with thinking or memory, weakness, feeling unsteady.

Common side effects of finerenone 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.

Many drugs can affect finerenone, and some drugs should not be used at the same time. Tell your doctor about all other medicines you use. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to finerenone.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.