Kerendia
(finerenone)Dosage & Administration
By using PrescriberAI, you agree to the AI Terms of Use.
Kerendia Prescribing Information
Kerendia 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 (T2DM).
- cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adult patients with heart failure with left ventricular ejection fraction (LVEF) ≥ 40%.
Prior to Initiation of Kerendia
Measure serum potassium levels and eGFR before initiation. Do not initiate treatment if serum potassium is > 5.0 mEq/L [see Warnings and Precautions (5.1)].
Recommended Starting Dosage
The recommended starting dose of Kerendia is based on eGFR and is presented in Table 1.
| eGFR (mL/min/1.73m2) | Starting Dose |
|---|---|
| ≥ 60 | 20 mg orally once daily |
| ≥ 25 to < 60 | 10 mg orally once daily |
| < 25 | Initiation is not recommended |
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 [see Clinical Pharmacology (12.3)].
Monitoring and Dosage Adjustment
CKD associated with T2DM
The target daily dose of Kerendia is 20 mg orally.
Measure serum potassium 4 weeks after initiating treatment and adjust dose (see Table 2); 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 [see Warnings and Precautions (5.1)]. Measure serum potassium 4 weeks after a dose adjustment and periodically throughout treatment, and adjust the dose as needed (see Table 2) [see Warnings and Precautions (5.1) and Drug Interactions (7.1)].
| Current Kerendia Dose | |||
|---|---|---|---|
| 10 mg once daily | 20 mg once daily | ||
| |||
| Current Serum Potassium (mEq/L) | ≤ 4.8 | Increase the dose to 20 mg once daily. * | Maintain 20 mg once daily. |
| > 4.8 – 5.5 | Maintain 10 mg once daily. | Maintain 20 mg once daily. | |
| > 5.5 | Withhold Kerendia. Consider restarting at 10 mg once daily when serum potassium ≤ 5.0 mEq/L. | Withhold Kerendia. Restart at 10 mg once daily when serum potassium ≤ 5.0 mEq/L. | |
Heart Failure with LVEF ≥ 40%
The target daily dose of Kerendia for heart failure (LVEF ≥ 40%) is dependent on renal function (eGFR) at initiation of Kerendia treatment (see Table 3).
- The target daily dose is 40 mg orally once daily if eGFR at initiation is ≥ 60 mL/min/1.73m2.
- The target daily dose is 20 mg orally once daily if eGFR at initiation is ≥ 25 to < 60 mL/min/1.73m2.
Measure serum potassium and eGFR 4 weeks after initiating treatment and adjust dose (see Table 3). Measure serum potassium and eGFR 4 weeks after a dose adjustment and monitor periodically throughout treatment, and adjust the dose as needed (see Table 3) [see Warnings and Precautions (5.1 & 5.2) and Drug Interactions (7.1)].
| Current Kerendia Dose | ||||
|---|---|---|---|---|
| 10 mg once daily | 20 mg once daily | 40 mg once daily | ||
| ||||
| Current Serum Potassium (mEq/L) | < 5.0 | Increase the dose to 20 mg once daily * | Maintain 20 mg once daily if eGFR < 60 mL/min/1.73 m2 at initiation. Otherwise increase the dose to 40 mg once daily * | Maintain 40 mg once daily. |
| ≥ 5.0 to < 5.5 | Maintain current dose. | |||
| ≥ 5.5 to < 6.0 | Withhold Kerendia. Restart at 10 mg once daily when serum potassium < 5.5 mEq/L. | Decrease to 10 mg once daily. | Decrease to 20 mg once daily. | |
| ≥ 6.0 | Withhold Kerendia. Restart at 10 mg once daily when serum potassium < 5.5 mEq/L. † | |||
Missed Doses
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.
Kerendia is available as film-coated, oblong tablets in three strengths.
- 10 mg: pink, with "FI" on one side, "10" on the other side.
- 20 mg: yellow, with "FI" on one side, "20" on the other side.
- 40 mg: gray-orange, with "FI" on one side, "40" on the other side.
Pregnancy
Risk Summary
There are no available data on Kerendia use in pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal studies have shown developmental toxicity at exposures about 2 times those expected in humans (see Data). The clinical significance of these findings is unclear.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Data
Animal Data
In the embryo-fetal toxicity study in rats, finerenone resulted in reduced placental weights and signs of fetal toxicity, including reduced fetal weights and retarded ossification at the maternal toxic dose of 10 mg/kg/day corresponding to an AUCunbound of at least 7 times that in humans. At 30 mg/kg/day, the incidence of visceral and skeletal variations was increased (slight edema, shortened umbilical cord, slightly enlarged fontanelle) and one fetus showed complex malformations including a rare malformation (double aortic arch) at an AUCunbound of about 10 times that in humans at the 40 mg dose and about 25 times that in humans at the 20 mg dose. The doses free of any findings (low dose in rats, high dose in rabbits) provide safety margins of 4 to 5 times for the AUCunbound expected in humans.
When rats were exposed during pregnancy and lactation in the pre- and postnatal developmental toxicity study, increased pup mortality and other adverse effects (lower pup weight, delayed pinna unfolding) were observed at about 2 or 4 times the AUCunbound expected in humans at the dose of 40 mg and 20 mg, respectively. In addition, the offspring showed slightly increased locomotor activity, but no other neurobehavioral changes starting at about 2 or 4 times the AUCunbound expected in humans at the dose of 40 mg and 20 mg, respectively. The dose free of findings provides a safety margin of about 2 times for the AUCunbound expected in humans for the 20 mg dose and is in the therapeutic range for the 40 mg dose.
Lactation
Risk Summary
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. In a pre- and postnatal developmental toxicity study in rats, increased pup mortality and lower pup weight were observed at about 2 times the AUCunbound expected in humans. These findings suggest that finerenone is present in rat milk [see Use in Specific Populations (8.1) and Data]. When a drug is present in animal milk, it is likely that the drug will be present in human milk. Because of the potential risk to breastfed infants from exposure to Kerendia, avoid breastfeeding during treatment and for 1 day after treatment.
Pediatric Use
The safety and efficacy of Kerendia have not been established in patients below 18 years of age.
Geriatric Use
Of the 6510 patients who received Kerendia in the FIDELIO-DKD and FIGARO-DKD studies, 55% of patients were 65 years and older, and 14% were 75 years and older. Of the 2993 patients who received Kerendia in the FINEARTS study, 79% of patients were 65 years and older, and 43% were 75 years and older. No overall differences in safety or efficacy were observed between these patients and younger patients. No dose adjustment is required.
Hepatic Impairment
Avoid use of Kerendia in patients with severe hepatic impairment (Child Pugh C).
No dosage adjustment is recommended in patients with mild or moderate hepatic impairment (Child Pugh A or B).
Consider additional serum potassium monitoring in patients with moderate hepatic impairment (Child Pugh B) [see Dosing and Administration (2.3) and Clinical Pharmacology (12.3)].
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.
Hyperkalemia
Kerendia can cause hyperkalemia [see Adverse Reactions (6.1)].
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 [see Dosage and Administration (2.1)]. Do not initiate Kerendia if serum potassium is > 5.0 mEq/L.
Measure serum potassium periodically during treatment with Kerendia and adjust dose accordingly [see Dosage and Administration (2.3)]. 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 [see Drug Interactions (7.1, 7.2)].
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 [see Adverse Reactions (6.1)].
Measure eGFR in all patients before initiation of treatment or with dose titration of Kerendia and dose accordingly [see Dosage and Administration (2.1, 2.3)]. Initiation of Kerendia in patients with heart failure and an eGFR <25 mL/min/1.73m2 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.