Kerendia

/ Bayer

Prior to Initiation of this medical product
Measure serum potassium levels and estimated glomerular filtration rate (eGFR) before initiation. Do not initiate treatment if serum potassium is > 5.0 mEq/L.
Recommended Starting Dosage
According to eGFR (mL/min/1.73m2)
> 60 – 20 mg once daily
≥ 25 to < 60 – 10 mg once daily
< 25- not recommended
For patients who are unable to swallow whole tablets, crushed and mixed with water or soft foods such as applesauce immediately prior to use and administered orally.
Monitoring and Dose Adjustment
The target daily dose is 20 mg.
Measure serum potassium 4 weeks after initiating treatment and adjust dose.
See prescribing information for full details.

Reduce the risk of sustained 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).

* Hypersensitivity to the active substance or to any of the excipients
* Concomitant treatment with strong CYP3A4 inhibitors
* Adrenal insufficiency

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 and dose accordingly. Do not initiate finerenone if serum potassium is > 5.0 mEq/L.
Measure serum potassium periodically during treatment 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
In patients with heart failure, severe events associated with worsening renal function, including events requiring hospitalization, have been rarely observed.
Measure eGFR in all patients before initiation of treatment or with dose titration and dose accordingly. Initiation of finerenone in patients with heart failure and an eGFR <25 mL/min/1.73m2 is not recommended.
Measure eGFR periodically during maintenance treatment in patients with heart failure. Consider delaying up-titration or interrupting treatment in patients who develop clinically significant worsening of renal function.

In the pivotal clinical studies, the most frequently reported adverse reaction (≥10%) was hyperkalemia. Hospitalization due to hyperkalemia occurred in 0.9% of patients in the finerenone group compared with 0.2% in the placebo group. Hyperkalemia led to permanent discontinuation of treatment in 1.7% of patients receiving finerenone versus 0.6% of patients receiving placebo.
See prescribing information for full details.

CYP3A4 Inhibitors and Inducers
Strong CYP3A4 Inhibitors
Finerenone is a CYP3A4 substrate. Concomitant use with a strong CYP3A4 inhibitor increases finerenone exposure, which may increase the risk for adverse reactions. Concomitant use of this medical product with strong CYP3A4 inhibitors is contraindicated. Avoid concomitant intake of grapefruit or grapefruit juice.
Moderate and Weak CYP3A4 Inhibitors
Concomitant use with a moderate or weak CYP3A4 inhibitor increases finerenone exposure, which may increase the risk for adverse reactions. Monitor serum potassium during drug initiation or dosage adjustment of either finerenone or the moderate or weak CYP3A4 inhibitor, and adjust finerenone dosage as appropriate
Strong and Moderate CYP3A4 Inducers
Concomitant use with a strong or moderate CYP3A4 inducer decreases finerenone exposure, which may reduce the efficacy. Avoid concomitant use with strong or moderate CYP3A4 inducers.
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.

Pregnancy: There are no available data on finerenone use in pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.
Lactation: There are no data on the presence of finerenone or its metabolite in human milk, the effects on the breastfed infant or the effects of the drug on milk production. Because of the potential risk to breastfed infants from exposure to finerenone, avoid breastfeeding during treatment and for 1 day after treatment.

In the event of suspected overdose, immediately interrupt 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%.