FINERENONE Drug Interactions: What You Need to Know

INTERACTIONS Strong CYP3A4 Inhibitors: Use is contraindicated. ( 7.1 ) Grapefruit or grapefruit juice: Avoid concomitant use. ( 7.1 ) Moderate or weak CYP3A4 Inhibitors: 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 ( 7.1 ) Strong or moderate CYP3A4 Inducers: Avoid concomitant use. ( 7.1 ) Sensitive CYP2C8 substrates at Kerendia 40 mg: Monitor more frequently for adverse reactions. ( 7.2 )

7.1 Effect of Other Drugs on Kerendia Strong CYP3A4 Inhibitors Kerendia is a CYP3A4 substrate. Concomitant use with a strong CYP3A4 inhibitor increases finerenone exposure <span class="opacity-50 text-xs">[see Clinical Pharmacology (12.3) ]</span> , which may increase the risk of Kerendia adverse reactions. Concomitant use of Kerendia with strong CYP3A4 inhibitors is contraindicated <span class="opacity-50 text-xs">[see Contraindications (4) ]</span> . 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 <span class="opacity-50 text-xs">[see Clinical Pharmacology (12.3) ]</span> , 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 <span class="opacity-50 text-xs">[see Dosing and Administration (2.3) and Drug Interaction (7.2) ]</span> . Strong and Moderate CYP3A4 Inducers Kerendia is a CYP3A4 substrate. Concomitant use of Kerendia with a strong or moderate CYP3A4 inducer decreases finerenone exposure <span class="opacity-50 text-xs">[see Clinical Pharmacology (12.3) ]</span>, which may reduce the efficacy of Kerendia. Avoid concomitant use of Kerendia with strong or moderate CYP3A4 inducers.

7.2 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 <span class="opacity-50 text-xs">[see Clinical Pharmacology (12.3) ]</span> , 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 co-administered with such substrates since minimal concentration changes may lead to serious adverse reactions.

7.3 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. <span class="opacity-50 text-xs">[see Dosage and Administration (2.3) and Warnings and Precautions (5.1) ]</span>.

Kerendia is contraindicated in patients: Who are hypersensitive to any component of this product [see Adverse Reactions (6.2) ] . Who are receiving concomitant treatment with strong CYP3A4 inhibitors [see Drug Interactions (7.1) ]. With adrenal insufficiency. Concomitant use with strong CYP3A4 inhibitors. ( 4 , 7.1 ) Patients with adrenal insufficiency. ( 4 ) Hypersensitivity to any component of this product. ( 4 )

AND PRECAUTIONS Hyperkalemia. Patients with decreased kidney function and higher baseline potassium levels are at increased risk. Monitor serum potassium levels and adjust dose as needed. ( 2.1 , 2.2 , 2.3 , 5.1 ) Worsening of Renal Function in Patients with Heart Failure. Measure eGFR and adjust dose as needed. ( 2.1 , 2.3 , 6.1 )

5.1 Hyperkalemia Kerendia can cause hyperkalemia <span class="opacity-50 text-xs">[see Adverse Reactions (6.1) ]</span> . The risk for developing hyperkalemia increases with decreasing kidney function and is greater in patients with higher baseline potassium levels or other risk factors for hyperkalemia. Measure serum potassium and eGFR in all patients before initiation of treatment with Kerendia and dose accordingly <span class="opacity-50 text-xs">[see Dosage and Administration (2.1) ]</span> . Do not initiate Kerendia if serum potassium is &gt; 5.0 mEq/L. Measure serum potassium periodically during treatment with Kerendia and adjust dose accordingly <span class="opacity-50 text-xs">[see Dosage and Administration (2.3) ]</span> . More frequent monitoring may be necessary for patients at risk for hyperkalemia, including those on concomitant medications that impair potassium excretion or increase serum potassium <span class="opacity-50 text-xs">[see Drug Interactions (7.1 , 7.2) ]</span> .

5.2 Worsening of Renal Function in Patients with Heart Failure Kerendia can cause worsening of renal function in patients with heart failure. Rarely, severe events associated with worsening renal function, including events requiring hospitalization, have been observed <span class="opacity-50 text-xs">[see Adverse Reactions (6.1) ]</span> . Measure eGFR in all patients before initiation of treatment or with dose titration of Kerendia and dose accordingly <span class="opacity-50 text-xs">[see Dosage and Administration (2.1 , 2.3) ]</span>. Initiation of Kerendia in patients with heart failure and an eGFR &lt;25 mL/min/1.73m 2 is not recommended. Measure eGFR periodically during maintenance treatment with Kerendia in patients with heart failure. Consider delaying up-titration or interrupting treatment with Kerendia in patients who develop clinically significant worsening of renal function.