b'KERENDIA (finerenone) tablets, for oral use84 patientsreceivingplacebo.Hyperkalemialedtopermanent Initial U.S. Approval: 2021 discontinuationoftreatmentin2.3%ofpatientsreceiving Kerendia versus 0.9% of patients receiving placebo.BRIEF SUMMARY OF PRESCRIBING INFORMATION Themostfrequentlyreported(10%)adversereaction CONSULT PACKAGE INSERT FOR washyperkalemia[seeWarningsandPrecautions(5.1)]. FULL PRESCRIBING INFORMATION Hospitalization due to hyperkalemia for the Kerendia group was 1INDICATIONS AND USAGE 1.4% versus 0.3% in the placebo group. Kerendia is indicated to reduce the risk of sustained eGFRTable 3 shows adverse reactions in FIDELIO-DKD that occurred decline, end-stage kidney disease, cardiovascular death, non- more commonly on Kerendia than on placebo, and in at least fatal myocardial infarction, and hospitalization for heart failure1% of patients treated with Kerendia.in adult patients with chronic kidney disease (CKD) associatedTable 3: Adverse reactions reported in1% of patients on with type 2 diabetes (T2D).Kerendia and more frequently than placebo in the 4CONTRAINDICATIONS phase 3 study FIDELIO-DKDKerendia is contraindicated in patients:AdverseKerendia Placebo Whoarereceivingconcomitanttreatmentwithstrongreactions N = 2827 N = 2831 CYP3A4 inhibitors [see Drug Interactions (7.1)]. n (%) n (%) With adrenal insufficiency. Hyperkalemia 516 (18.3) 255 (9.0)Hypotension 135 (4.8) 96 (3.4)5WARNINGS AND PRECAUTIONS Hyponatremia 40 (1.4) 19 (0.7)5.1HyperkalemiaKerendia can cause hyperkalemia [(see Adverse Reactions (6.1)].Laboratory TestThe risk for developing hyperkalemia increases with decreasingInitiation of Kerendia may cause an initial small decrease in kidney function and is greater in patients with higher baselineestimated GFR that occurs within the first 4 weeks of starting potassiumlevelsorotherriskfactorsforhyperkalemia.therapy, and then stabilizes. In a study that included patients MeasureserumpotassiumandeGFRinallpatientsbeforewith chronic kidney disease associated with type 2 diabetes, initiation of treatment with Kerendia and dose accordingly [seethis decrease was reversible after treatment discontinuation. Dosage and Administration (2.1)]. Do not initiate Kerendia if serum potassium is 5.0 mEq/L.7DRUG INTERACTIONSMeasureserumpotassiumperiodicallyduringtreatment7.1CYP3A4 Inhibitors and Inducerswith Kerendia and adjust dose accordingly [see Dosage andStrong CYP3A4 InhibitorsAdministration(2.3)].MorefrequentmonitoringmaybeKerendia is a CYP3A4 substrate. Concomitant use with a strong necessaryforpatientsatriskforhyperkalemia,includingCYP3A4 inhibitor increases finerenone exposure [see Clinical thoseonconcomitantmedicationsthatimpairpotassiumPharmacology (12.3)], which may increase the risk of Kerendia excretion or increase serum potassium [see Drug Interactionsadverse reactions. Concomitant use of Kerendia with strong (7.1), 7.2)]. CYP3A4inhibitorsiscontraindicated[seeContraindications (4)]. Avoid concomitant intake of grapefruit or grapefruit juice. 6ADVERSE REACTIONS Moderate and Weak CYP3A4 InhibitorsThe following serious adverse reactions are discussed else- KerendiaisaCYP3A4substrate.Concomitantusewitha where in the labeling: moderateorweakCYP3A4inhibitorincreasesfinerenoneHyperkalemia [see Warnings and Precautions (5.1)] exposure[seeClinicalPharmacology(12.3)],whichmay 6.1Clinical Trials Experience increasetheriskofKerendiaadversereactions.Monitor Becauseclinicaltrialsareconductedunderwidelyvaryingserum potassium during drug initiation or dosage adjustment conditions, adverse reaction rates observed in the clinical trialsof either Kerendia or the moderate or weak CYP3A4 inhibitor, of a drug cannot be directly compared to rates in the clinicaland adjust Kerendia dosage as appropriate [see Dosing and trials of another drug and may not reflect the rates observedAdministration (2.3) and Drug Interaction (7.2)].in practice. Strong and Moderate CYP3A4 InducersThesafetyofKerendiawasevaluatedintherandomized,Kerendia is a CYP3A4 substrate. Concomitant use of Kerendia double-blind,placebo-controlled,multicenterpivotalphasewithastrongormoderateCYP3A4inducerdecreases 3 study FIDELIO-DKD. In this study, 2827 patients receivedfinerenone exposure [see Clinical Pharmacology (12.3)], which Kerendia (10 or 20 mg once daily) and 2831 received placebo.may reduce the efficacy of Kerendia. Avoid concomitant use of ForpatientsintheKerendiagroup,themeandurationofKerendia with strong or moderate CYP3A4 inducers.treatment was 2.2 years. 7.2Drugs That Affect Serum PotassiumOverall,seriousadversereactionsoccurredin32%ofMorefrequentserumpotassiummonitoringiswarranted patients receiving Kerendia and in 34% of patients receivinginpatientsreceivingconcomitanttherapywithdrugsor placebo. Permanent discontinuation due to adverse reactionssupplements that increase serum potassium [see Dosage and occurred in 7% of patients receiving Kerendia and in 6% ofAdministration (2.3) and Warnings and Precautions (5.1)].'