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NEWLY INDICATED FOR ADULTS WITH HF LVEF ≥40%23

HF LVEF=heart failure with left ventricular ejection fraction.

NEWLY INDICATED FOR ADULTS WITH HF LVEF ≥40%23

HF LVEF=heart failure with left ventricular ejection fraction.

NEWLY INDICATED FOR ADULTS WITH HF LVEF ≥40%23

HF LVEF=heart failure with left ventricular ejection fraction.

NEWLY INDICATED FOR ADULTS WITH HF LVEF ≥40%23

HF LVEF=heart failure with left ventricular ejection fraction.

In adult patients with CKD associated with T2D

Your patients with T2D remain at risk for life-threatening CV events15,23,30,31

 

    Although Kate is on standard of care, her persistent albuminuria indicates that she is still at elevated risk for serious CV events15,30

    Not a real patient.

    Alt tag

    Current therapies1

    • Maximum-tolerated dose of ARB
    • SGLT2i
    • CCB
    • Thiazide diuretic
    • Metformin

    Labs

    • eGFR: 81 mL/min/1.73 m2
    • UACR: 388 mg/g

    Compared with patients with preserved eGFR and UACR <10 mg/g38

    Kate has a 2.4x higher risk of dying from CV causes22
    Assess patient’s CV risk

    Not a real patient.

    Compared with patients with preserved eGFR and UACR <10 mg/g38

    Kate has a 2.4x higher risk of dying from CV causes22

    Kate, Henry, and Kathy face an increased risk of CV mortality7,16,22

    Graph of increased risk of cardiovascular mortality for patients Kate, Henry, and Kathy

    The percentile shaded the darkest green color corresponds to the proportion of cells in the grid without CKD (eg, 6 of 35 cells with eGFR ≥60 mL/min/1.73 m2 and UACR <30 mg/g), and the percentile shaded the darkest red color corresponds to the proportion expected to be at the highest risk for adverse outcomes (eg, 11 of 35 cells with eGFR <15 mL/min/1.73 m2 and UACR ≥1000 mg/g).38

    Reproduced with permission from JAMA, Writing Group for the CKD Prognosis Consortium; Grams ME, Coresh J, Matsushita K, et al. Estimated glomerular filtration rate, albuminuria, and adverse outcomes: an individual participant data meta-analysis. JAMA. 2023;330(13):1266-1277.

    Graph of increased risk of cardiovascular mortality for patients Kate, Henry, and Kathy

    Reproduced with permission from JAMA, Writing Group for the CKD Prognosis Consortium; Grams ME, Coresh J, Matsushita K, et al. Estimated glomerular filtration rate, albuminuria, and adverse outcomes: an individual participant data meta-analysis. JAMA. 2023;330(13):1266-1277.

    The percentile shaded the darkest green color corresponds to the proportion of cells in the grid without CKD (eg, 6 of 35 cells with eGFR ≥60 mL/min/1.73 m2 and UACR <30 mg/g), and the percentile shaded the darkest red color corresponds to the proportion expected to be at the highest risk for adverse outcomes (eg, 11 of 35 cells with eGFR <15 mL/min/1.73 m2 and UACR ≥1000 mg/g).38

    View patient profile

    Although Henry is on standard of care, his CKD progression indicates an increased risk for serious CV events15,30

    Not a real patient.

    Alt tag

    Current therapies1

    • Maximum-tolerated dose of ARB
    • Beta-blocker
    • Statin
    • Metformin
    • SGLT2i

    Labs

    • eGFR: 55 mL/min/1.73 m2
    • UACR: 200 mg/g

    Compared with patients with preserved eGFR and UACR <10 mg/g38

    Henry has a 2.2x higher risk of dying from CV causes22
    Assess patient’s CV risk

    Not a real patient.

    Compared with patients with preserved eGFR and UACR <10 mg/g38

    Henry has a 2.2x higher risk of dying from CV causes22

    Kate, Henry, and Kathy face an increased risk of CV mortality7,16,22

    Graph of increased risk of cardiovascular mortality for patients Kate, Henry, and Kathy

    The percentile shaded the darkest green color corresponds to the proportion of cells in the grid without CKD (eg, 6 of 35 cells with eGFR ≥60 mL/min/1.73 m2 and UACR <30 mg/g), and the percentile shaded the darkest red color corresponds to the proportion expected to be at the highest risk for adverse outcomes (eg, 11 of 35 cells with eGFR <15 mL/min/1.73 m2 and UACR ≥1000 mg/g).38

    Reproduced with permission from JAMA, Writing Group for the CKD Prognosis Consortium; Grams ME, Coresh J, Matsushita K, et al. Estimated glomerular filtration rate, albuminuria, and adverse outcomes: an individual participant data meta-analysis. JAMA. 2023;330(13):1266-1277.

    Graph of increased risk of cardiovascular mortality for patients Kate, Henry, and Kathy

    Reproduced with permission from JAMA, Writing Group for the CKD Prognosis Consortium; Grams ME, Coresh J, Matsushita K, et al. Estimated glomerular filtration rate, albuminuria, and adverse outcomes: an individual participant data meta-analysis. JAMA. 2023;330(13):1266-1277.

    The percentile shaded the darkest green color corresponds to the proportion of cells in the grid without CKD (eg, 6 of 35 cells with eGFR ≥60 mL/min/1.73 m2 and UACR <30 mg/g), and the percentile shaded the darkest red color corresponds to the proportion expected to be at the highest risk for adverse outcomes (eg, 11 of 35 cells with eGFR <15 mL/min/1.73 m2 and UACR ≥1000 mg/g).38

    View patient profile

    Although Kathy is on standard of care, serious cardiovascular risk remains15,30

    Not a real patient.

    Alt tag

    Current therapies1

    • Maximum-tolerated dose of ARB
    • CCB
    • Thiazide diuretic
    • Metformin

    Labs

    • eGFR: 55 mL/min/1.73 m2
    • UACR: 350 mg/g

    Compared with patients with preserved eGFR and UACR <10 mg/g38

    Kathy has a 2.8x higher risk of dying from CV causes22
    Assess patient’s CV risk

    Not a real patient.

    Compared with patients with preserved eGFR and UACR <10 mg/g38

    Kathy has a 2.8x higher risk of dying from CV causes22

    Kate, Henry, and Kathy face an increased risk of CV mortality7,16,22

    Graph of increased risk of cardiovascular mortality for patients Kate, Henry, and Kathy

    The percentile shaded the darkest green color corresponds to the proportion of cells in the grid without CKD (eg, 6 of 35 cells with eGFR ≥60 mL/min/1.73 m2 and UACR <30 mg/g), and the percentile shaded the darkest red color corresponds to the proportion expected to be at the highest risk for adverse outcomes (eg, 11 of 35 cells with eGFR <15 mL/min/1.73 m2 and UACR ≥1000 mg/g).38

    Reproduced with permission from JAMA, Writing Group for the CKD Prognosis Consortium; Grams ME, Coresh J, Matsushita K, et al. Estimated glomerular filtration rate, albuminuria, and adverse outcomes: an individual participant data meta-analysis. JAMA. 2023;330(13):1266-1277.

    Graph of increased risk of cardiovascular mortality for patients Kate, Henry, and Kathy

    Reproduced with permission from JAMA, Writing Group for the CKD Prognosis Consortium; Grams ME, Coresh J, Matsushita K, et al. Estimated glomerular filtration rate, albuminuria, and adverse outcomes: an individual participant data meta-analysis. JAMA. 2023;330(13):1266-1277.

    The percentile shaded the darkest green color corresponds to the proportion of cells in the grid without CKD (eg, 6 of 35 cells with eGFR ≥60 mL/min/1.73 m2 and UACR <30 mg/g), and the percentile shaded the darkest red color corresponds to the proportion expected to be at the highest risk for adverse outcomes (eg, 11 of 35 cells with eGFR <15 mL/min/1.73 m2 and UACR ≥1000 mg/g).38

    View patient profile

    For your adult patients with CKD associated with T2D

    Elevated albuminuria increases their risk for cardiovascular events23,33

    Detection of persistent UACR ≥30 is crucial to identify CKD, which puts your patients with T2D at significant CV risk7,16,28

    Expert insights on identifying KERENDIA patients and clinical use

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    Dr. Jessica Coleman provides an overview of KERENDIA: how it was studied, whom it’s approved for, and how you can use it in your practice.

    Identifying the KERENDIA Patient Coleman FINAL 2024

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    *Data are based on a multicenter, randomized study that evaluated the safety of saxagliptin vs placebo in patients with T2D with overt CVD or multiple risk factors.35

    Than patients with T2D but without albuminuria.33,35

    Defined as UACR ≥30 mg/g for more than 3 months16,28

    ACR=albumin-to-creatinine ratio; ARB=angiotensin receptor blocker; CCB=calcium channel blocker; CKD=chronic kidney disease; CV=cardiovascular; CVD=cardiovascular disease; eGFR=estimated glomerular filtration rate; JAMA=Journal of American Medicine; SGLT2i=sodium-glucose cotransporter 2 inhibitor; T2D=type 2 diabetes; UACR=urine albumin-to-creatinine ratio.

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    INDICATIONS:

    KERENDIA (finerenone) is indicated to reduce the risk of:

    • sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) (10mg, 20mg tablets)
    • cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adult patients with heart failure with left ventricular ejection fraction (HF LVEF) ≥40% (10mg, 20mg, 40mg tablets)

    IMPORTANT SAFETY INFORMATION

    CONTRAINDICATIONS:

    • Hypersensitivity to any component of this product
    • Concomitant use with strong CYP3A4 inhibitors
    • Patients with adrenal insufficiency

    WARNINGS AND PRECAUTIONS:

    • Hyperkalemia: KERENDIA can cause hyperkalemia. 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. Do not initiate KERENDIA if serum potassium is >5 mEq/L. Measure serum potassium periodically during treatment with KERENDIA and adjust dose accordingly. 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.

    • 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

       

      Measure eGFR in all patients before initiation of treatment or with dose titration of KERENDIA and dose accordingly. Initiation of KERENDIA in patients with heart failure and an eGFR <25 mL/min/1.73 m2 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

    MOST COMMON ADVERSE REACTIONS:

    • CKD associated with T2D: From the pooled data of FIDELIO-DKD and FIGARO-DKD, the adverse reactions reported in ≥1% of patients on KERENDIA and more frequently than placebo were hyperkalemia (14% vs 6.9%), hypotension (4.6% vs 3%), and hyponatremia (1.3% vs 0.7%).
    • HF LVEF ≥40%: From FINEARTS-HF, the adverse reactions reported in ≥1% of patients on KERENDIA and more frequently than placebo were hyperkalemia (9.7% vs 4.2%), hypotension (7.6% vs 4.7%), and hyponatremia (1.9% vs 0.9%). Events related to worsening renal function were reported more frequently in the KERENDIA group (18%) compared with placebo (12%).

    DRUG INTERACTIONS:

    • Strong CYP3A4 Inhibitors: Concomitant use of KERENDIA with strong CYP3A4 inhibitors is contraindicated. Avoid concomitant intake of grapefruit or grapefruit juice.
    • Moderate and 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.
    • Strong and Moderate CYP3A4 Inducers: Avoid concomitant use of KERENDIA with strong or moderate CYP3A4 inducers.
    • Sensitive CYP2C8 Substrates at KERENDIA 40mg: Monitor patients more frequently for adverse reactions caused by sensitive CYP2C8 substrates if KERENDIA 40mg is co-administered with such substrates, since minimal concentration changes may lead to serious adverse reactions.

    USE IN SPECIFIC POPULATIONS:

    • Lactation: Avoid breastfeeding during treatment with KERENDIA and for 1 day after treatment.
    • Hepatic Impairment: Avoid use of KERENDIA in patients with severe hepatic impairment (Child Pugh C) and consider additional serum potassium monitoring with moderate hepatic impairment (Child Pugh B).

    Please see the full Prescribing Information for KERENDIA.