Finerenone
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From MedlinePlus, U.S. National Library of Medicine
Nonsteroidal Mineralocorticoid-Receptor Antagonist
Dosing in kidney impairment
2 DOSAGE AND ADMINISTRATION The recommended starting dosage is 10 mg or 20 mg orally once daily based on eGFR and serum potassium thresholds. Increase dosage after 4 weeks to the target dose of 20 mg once daily for CKD and T2DM based on eGFR and serum potassium thresholds. Increase dosage after 4 weeks to the target dose of 20 mg or 40 mg once daily for HF with LVEF ≥ 40% based on eGFR and serum potassium thresholds.
Tablets may be taken with or without food 2.1 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 ]. 2.2 Recommended Starting Dosage The recommended starting dose of Kerendia is based on eGFR and is presented in Table 1. [See table below.] 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 ] . 2.3 Monitoring and Dosage Adjustment CKD associated with T2DM The target daily dose of Kerendia is 20 mg orally.
Measure serum potassium 4 weeks after a dose adjustment and periodically throughout treatment, and adjust the dose as needed (see Table 2 ) [see Warnings and Precautions and Drug Interactions ]. [See table below.] 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/1.73m 2 . The target daily dose is 20 mg orally once daily if eGFR at initiation is ≥ 25 to < 60 mL/min/1.73m 2 . 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 ]. [See table below.] < 5.5 mEq/L.
Dosing in liver impairment
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 and Clinical Pharmacology ].
Preparation and administration
| 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.If eGFR has decreased by more than 30% compared to previous measurement, maintain 10 mg dose. | 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. | |
| 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 dailyIf eGFR has decreased by more than 30% compared to previous measurement, maintain current dose. | 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.If repeated serum potassium measurements are ≥5.5 mEq/L, restart Kerendia at 10 mg once daily when serum potassium < 5.0 mEq/L. | |||
Drug interactions
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- Finerenone
Label text (5 paragraphs)
Strong CYP3A4 Inhibitors: Use is contraindicated. ( 7.1 ) Grapefruit or grapefruit juice: Avoid concomitant use. ( 7.1 ) Moderate or 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 ( 7.1 ) Strong or moderate CYP3A4 Inducers: Avoid concomitant use. ( 7.1 ) Sensitive CYP2C8 substrates at Kerendia 40 mg: Monitor more frequently for adverse reactions. ( 7.2 )
7.1 Effect of Other Drugs on Kerendia Strong CYP3A4 Inhibitors Kerendia is a CYP3A4 substrate. Concomitant use with a strong CYP3A4 inhibitor increases finerenone exposure [see Clinical Pharmacology (12.3) ] , which may increase the risk of Kerendia adverse reactions. Concomitant use of Kerendia with strong CYP3A4 inhibitors is contraindicated [see Contraindications (4) ] . Avoid concomitant intake of grapefruit or grapefruit juice. Moderate and Weak CYP3A4 Inhibitors Kerendia is a CYP3A4 substrate. Concomitant use with a moderate or weak CYP3A4 inhibitor increases finerenone exposure [see Clinical Pharmacology (12.3) ] , which may increase the risk of Kerendia adverse reactions.
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 [see Dosing and Administration (2.3) and Drug Interaction (7.2) ] . Strong and Moderate CYP3A4 Inducers Kerendia is a CYP3A4 substrate. Concomitant use of Kerendia with a strong or moderate CYP3A4 inducer decreases finerenone exposure [see Clinical Pharmacology (12.3) ], which may reduce the efficacy of Kerendia. Avoid concomitant use of Kerendia with strong or moderate CYP3A4 inducers.
7.2 Effect of Kerendia on Other Drugs CYP2C8 Substrates Kerendia is a weak CYP2C8 inhibitor at 40 mg. Kerendia increases exposure of CYP2C8 substrates at 40 mg dose [see Clinical Pharmacology (12.3) ] , which may increase the risk of adverse reactions related to these substrates. Monitor patients more frequently for adverse reactions caused by sensitive CYP2C8 substrates if Kerendia 40 mg is co-administered with such substrates since minimal concentration changes may lead to serious adverse reactions.
7.3 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. [see Dosage and Administration (2.3) and Warnings and Precautions (5.1) ].
Contraindications
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. Concomitant use with strong CYP3A4 inhibitors. ( 4 , 7.1 ) Patients with adrenal insufficiency. ( 4 ) Hypersensitivity to any component of this product. ( 4 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
ELikelihood score E: Unlikely cause of clinically apparent liver injury.
Finerenone is a selective, nonsteroidal mineralocorticoid receptor antagonist that is used in the therapy of chronic renal disease in patients with type 2 diabetes to slow progression of renal dysfunction and reduce the risk of cardiovascular disease morbidity and mortality. Finerenone has not been linked to serum enzyme elevations during therapy or with instances of clinically apparent liver injury.
ABCDEA: well known cause; E: unlikely cause. [HD]: high doses only.
Pregnancy and lactation
Pregnancy
8.1 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 AUC unbound 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 AUC unbound 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 AUC unbound 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 AUC unbound 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 AUC unbound 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 AUC unbound expected in humans for the 20 mg dose and is in the therapeutic range for the 40 mg dose.
Breastfeeding (LactMed)
No information is available on the use of finerenone during breastfeeding. Finerenone is 92% bound to plasma proteins, so amounts in milk are likely to be low. However, the manufacturer recommends avoiding breastfeeding during treatment and for 1 day after treatment.
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Recalls (last 24 months)
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