1.6-Dosing

For your adult patients with CKD associated with T2D

KERENDIA is a once-daily treatment option

Getting started

Dose modifications

Measure serum K+ and eGFR before dose initiation

DO NOT INITIATE if serum K+ is >5.0 mEq/L* or if eGFR is <25 mL/min/1.73 m²

eGFR (mL/min/1.73 m²)

≥25 to <60

≥60

Starting dose

10 mg

20 mg

Target daily dose^†

20 mg

The recommended starting dose and target daily dose is
based on initial eGFR and serum K+ thresholds.

Not actual size.

Additional dosing information:

For patients who are unable to swallow whole tablets, KERENDIA may be crushed and mixed with water or soft foods, such as applesauce, immediately prior to use and administered orally
Avoid taking KERENDIA with grapefruit or grapefruit juice
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

*If serum potassium levels are >4.8 to 5.0 mEq/L, initiation of KERENDIA treatment may be considered with additional serum potassium monitoring within the first 4 weeks based on clinical judgment and serum potassium levels. ^†Target daily dose to be achieved after week 4.

CKD=chronic kidney disease; eGFR=estimated glomerular filtration rate; K+=potassium.

Measure serum K+ levels 4 weeks after initiation, restart, or dose adjustment

WITHHOLD TREATMENT if serum K+ is >5.5 mEq/L and consider restarting at 10 mg once serum K+ is ≤5.0 mEq/L

Serum K+ level

Dose adjustment

≤4.8 mEq/L

Increase to* or maintain
at target dose

>4.8 to 5.5 mEq/L

Maintain current dose

Additional dosing information:

For patients who are unable to swallow whole tablets, KERENDIA may be crushed and mixed with water or soft foods, such as applesauce, immediately prior to use and administered orally
Avoid taking KERENDIA with grapefruit or grapefruit juice
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

*If eGFR has decreased by more than 30% compared to previous measurement, maintain current dose.

CKD=chronic kidney disease; eGFR=estimated glomerular filtration rate; K+=potassium.

IMPORTANT SAFETY INFORMATION AND INDICATIONS

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).

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)

Please see the full Prescribing Information for KERENDIA.

REFERENCES

KERENDIA is a once-daily treatment option

Additional dosing information:

Additional dosing information: