Finerenone

Finerenone is used in adults with chronic kidney disease related to type 2 diabetes mellitus to lower the risk of kidney problems worsening, kidney failure, a heart attack, needing to stay in the hospital for heart failure, or dying from heart or blood vessel issues.

Finerenone is also used in adults with a specific type of heart failure, with left ventricular ejection fraction (LVEF) 40% or higher, to lower the risk of dying from heart or blood vessel issues or needing urgent medical help or a hospital stay for heart failure.

Finerenone may also be used for reasons not mentioned in this medication guide.

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.

Finerenone is usually taken once per day. Follow your doctor's instructions.

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.

Your potassium levels and kidney function will need to be tested often. Your treatments may be reduced or delayed based on the results.

Store at room temperature away from moisture and heat.

You should not use finerenone if your adrenal glands do not make enough hormones.

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

You should not use finerenone if you are allergic to it, or if your adrenal glands do not make enough hormones.

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

• nefazodone;
• St. John's wort;
• an antibiotic--clarithromycin, rifabutin, rifampin, rifapentine, telithromycin;
• antifungal medicine--itraconazole, ketoconazole;
• antiviral medicine for HIV or hepatitis C--boceprevir, cobicistat, dasabuvir, elvitegravir, indinavir, lopinavir/ritonavir, nelfinavir, ombitasvir, paritaprevir, saquinavir, telaprevir, tipranavir;
• cancer medicine--apalutamide, enzalutamide, mitotane;
• seizure medicine--carbamazepine, oxcarbazepine, phenytoin, primidone; or
• steroid medicine--dexamethasone, prednisone.

Tell your doctor if you have or have ever had:

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

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 this medicine, and for at least 1 day after your last dose.

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

Finerenone may lead to serious side effects. Contact your doctor immediately if you experience:

• high blood potassium--nausea, weakness, tingling sensation, chest pain, irregular heartbeats, loss of movement; or
• kidney issues--swelling, urinating less, feeling tired or short of breath.

Common side effects of finerenone may include:

• high potassium levels in your blood;
• low sodium levels in your blood; or
• low blood pressure.

This is not a full list of side effects, and others may happen. Contact your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

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 dayTarget dose: 20 mg orally once a dayComments:-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.-Serum potassium should be measured 4 weeks after initiating treatment and dose should be adjusted; serum potassium should be monitored 4 weeks after dose adjustment and throughout therapy, and dose should be adjusted as needed.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

Usual Adult Dose for Heart Failure:

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 dayTarget dose: -For eGFR at least 60 mL/min/1.73 m2 at initiation of treatment: 40 mg orally once a day-For eGFR 25 to less than 60 mL/min/1.73 m2 at initiation of treatment: 20 mg orally once a dayComments:-Initiation of therapy is not recommended if serum potassium is greater than 5 mEq/L.-The target dose is dependent on renal function at initiation of treatment.-Serum potassium and eGFR should be measured 4 weeks after initiating treatment and dose should be adjusted; serum potassium and eGFR should be measured and monitored periodically throughout treatment, and dose should be adjusted as needed.Use: To reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in patients with heart failure with left ventricular ejection fraction more than or equal to 40%

Take the medicine as soon as you remember. If it's nearly time for your next scheduled dose, skip the missed dose. Do not take two doses in one day.

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

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.

Sometimes, it is not safe to use certain medicines together. Some drugs can change the blood levels of other drugs you take, which may increase side effects or make the medicines less effective.

Tell your doctor about all your other medicines, especially those that can affect your blood potassium levels, like potassium supplements.

Many drugs can affect finerenone. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are mentioned here. Tell your doctor about all other medicines you use.