WARNINGS
Do not take KERENDIA if you:
Are allergic to any of the ingredients in KERENDIA
Take certain medications called CYP3A4 inhibitors. Ask your healthcare provider if you are not sure if you are taking any of these medications
Have problems with your adrenal glands
USES
KERENDIA (finerenone) is a prescription medicine used to:
reduce the risk of worsening of kidney disease, kidney failure, death due to cardiovascular disease, heart attack, and hospitalization for heart failure in adults with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) (10mg, 20mg tablets)
reduce the risk of death due to cardiovascular disease, hospitalization for heart failure, and urgent heart failure visits in adults with heart failure with left ventricular ejection fraction (HF LVEF) of ≥40%, when the heart may pump normally, but may not fill properly (10mg, 20mg, 40mg tablets)
HOW TO USE
Only doctors are allowed to use this for patients.
KERENDIA may cause serious side effects, including:
High potassium levels in your blood (hyperkalemia). Your healthcare provider will check your potassium level before and during treatment with KERENDIA
Worsening of kidney function for patients with heart failure. Your healthcare provider will measure your kidney function before and during treatment with KERENDIA
The most common side effects of KERENDIA include hyperkalemia (high potassium level in your blood), hyperkalemia (potassium level in your blood that is higher than normal), hypotension (blood pressure that is lower than normal), and hyponatremia (sodium level in your blood that is lower than normal). Worsening of kidney function was also included in patients with heart failure.
N/A
OVERDOSE
In the event of suspected overdose, immediately interrupt Kerendia treatment. The most likely manifestation of overdose is hyperkalemia. If hyperkalemia develops, standard treatment should be initiated.
Finerenone is unlikely to be efficiently removed by hemodialysis given its fraction bound to plasma proteins of about 90%.
MISSED DOSE
Direct a patient to take a missed dose as soon as possible after it is noticed, but only on the same day. If this is not possible, the patient should skip the dose and continue with the next dose as prescribed.
STORAGE
Store at 20-degrees C to 25-degrees C (68-degrees F to 77-degrees F); excursions are permitted from 15-degrees C to 30-degrees C (59-degrees F to 86-degrees F).
NOTES
Medication Guide: revision date 08/2025
Prescribing Information: revision date 08/2025
1.) Effect of Other Drugs on Kerendia
Strong CYP3A4 Inhibitors
Kerendia is a CYP3A4 substrate. Concomitant use with a strong CYP3A4 inhibitor increases finerenone exposure [see Clinical Pharmacology (12.3)], which may increase the risk of Kerendia adverse reactions. Concomitant use of Kerendia with strong CYP3A4 inhibitors is contraindicated [see Contraindications (4)]. Avoid concomitant intake of grapefruit or grapefruit juice.
Moderate and Weak CYP3A4 Inhibitors
Kerendia is a CYP3A4 substrate. Concomitant use with a moderate or weak CYP3A4 inhibitor increases finerenone exposure [see Clinical Pharmacology (12.3)], which may increase the risk of Kerendia adverse reactions. Monitor serum potassium during drug initiation or dosage adjustment of either Kerendia or the moderate or weak CYP3A4 inhibitor, and adjust Kerendia dosage as appropriate [see Dosing and Administration (2.3) and Drug Interaction (7.2)].
Strong and Moderate CYP3A4 Inducers
Kerendia is a CYP3A4 substrate. Concomitant use of Kerendia with a strong or moderate CYP3A4 inducer decreases finerenone exposure [see Clinical Pharmacology (12.3)], which may reduce the efficacy of Kerendia. Avoid concomitant use of Kerendia with strong or moderate CYP3A4 inducers.
2.) Effect of Kerendia on Other Drugs
CYP2C8 Substrates
Kerendia is a weak CYP2C8 inhibitor at 40 mg. Kerendia increases exposure of CYP2C8 substrates at 40 mg dose, which may increase the risk of adverse reactions related to these substrates. Monitor patients more frequently for adverse reactions caused by sensitive CYP2C8 substrates if Kerendia 40 mg is coadministered with such substrates since minimal concentration changes may lead to serious adverse reactions.
3.) Drugs That Affect Serum Potassium
More frequent serum potassium monitoring is warranted in patients receiving concomitant therapy with drugs or supplements that increase serum potassium. [see the sections USAGE, WARNINGS, and PRECAUTIONS above].
Before you take KERENDIA, tell your healthcare provider about all your medical conditions, including if you:
Have high potassium levels in your blood (hyperkalemia) or take medications that may increase potassium levels in your blood
Have severe liver problems
Are pregnant or plan to become pregnant or are breastfeeding or plan to breastfeed. Avoid breastfeeding during treatment with KERENDIA and 1 day after treatment
Tell your healthcare provider about all the prescription and over-the-counter medicines you take, including salt substitutes, vitamins, and herbal or potassium supplements.
KERENDIA may affect the way other medications work, and other medications may affect how KERENDIA works. Do not start or stop any medicine before you talk with your healthcare provider. Avoid grapefruit or grapefruit juice as it may increase KERENDIA levels in the blood
