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Kerendia Generic Name & Formulations
Legal Class
Rx
General Description
Finerenone 10mg, 20mg; tabs.
Pharmacological Class
Nonsteroidal mineralocorticoid receptor antagonist (MRA).
How Supplied
Tabs—30, 90
Manufacturer
Generic Availability
NO
Kerendia Indications
Indications
To reduce the risk of sustained eGFR decline, end stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adults with chronic kidney disease associated with type 2 diabetes.
Kerendia Dosage and Administration
Adult
See full labeling. Swallow whole. If unable to swallow, tabs may be crushed and mixed with water or soft foods (eg, applesauce). eGFR (≥60mL/min/1.73m2): initially 20mg once daily; (≥25–<60mL/min/1.73m2): initially 10mg once daily; (<25mL/min/1.73m2): not recommended. Target dose: 20mg/day. Dose adjustment based on current serum K+ and current dose: if >5.5mEq/L, withhold dose and restart (for current 20mg/day dose) or consider restarting at 10mg once daily (for current 10mg/day dose) when serum K+ ≤5.0mEq/L; if >4.8–5.5mEq/L, maintain at current dose; if ≤4.8mEq/L, increase to 20mg once daily if current dose is 10mg once daily (if eGFR decreased by >30%, maintain dose at 10mg) or maintain at 20mg if current dose is 20mg once daily.
Children
<18yrs: not established.
Kerendia Contraindications
Contraindications
Concomitant strong CYP3A4 inhibitors (eg, itraconazole). Adrenal insufficiency.
Kerendia Boxed Warnings
Not Applicable
Kerendia Warnings/Precautions
Warnings/Precautions
Increased risk of hyperkalemia with decreasing kidney function and higher baseline K+ levels. Measure serum K+ and eGFR prior to initiation. Do not initiate if serum K+ is >5.0mEq/L. Measure serum K+ 4 weeks after initiation, periodically during treatment, and after dose adjustments. Severe hepatic impairment: avoid. Moderate hepatic impairment: consider more monitoring of serum K+. Pregnancy. Nursing mothers: not recommended (during and for 1 day after treatment).
Kerendia Pharmacokinetics
See Literature
Kerendia Interactions
Interactions
See Contraindications. Potentiated by strong CYP3A4 inhibitors. Avoid concomitant grapefruit or grapefruit juice. Potentiated by moderate or weak CYP3A4 inhibitors (eg, erythromycin, amiodarone); monitor and adjust dose appropriately. Antagonized by strong or moderate CYP3A4 inducers (eg, efavirenz, rifampicin); avoid. Concomitant with drugs or supplements that increase serum K+; monitor serum K+ more frequently.
Kerendia Adverse Reactions
Adverse Reactions
Hyperkalemia, hypotension, hyponatremia.
Kerendia Clinical Trials
See Literature
Kerendia Note
Not Applicable
Kerendia Patient Counseling
See Literature
Kerendia Generic Name & Formulations
Legal Class
Rx
General Description
Finerenone 10mg, 20mg; tabs.
Pharmacological Class
Nonsteroidal mineralocorticoid receptor antagonist (MRA).
How Supplied
Tabs—30, 90
Manufacturer
Generic Availability
NO
Kerendia Indications
Indications
To reduce the risk of sustained eGFR decline, end stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adults with chronic kidney disease associated with type 2 diabetes.
Kerendia Dosage and Administration
Adult
See full labeling. Swallow whole. If unable to swallow, tabs may be crushed and mixed with water or soft foods (eg, applesauce). eGFR (≥60mL/min/1.73m2): initially 20mg once daily; (≥25–<60mL/min/1.73m2): initially 10mg once daily; (<25mL/min/1.73m2): not recommended. Target dose: 20mg/day. Dose adjustment based on current serum K+ and current dose: if >5.5mEq/L, withhold dose and restart (for current 20mg/day dose) or consider restarting at 10mg once daily (for current 10mg/day dose) when serum K+ ≤5.0mEq/L; if >4.8–5.5mEq/L, maintain at current dose; if ≤4.8mEq/L, increase to 20mg once daily if current dose is 10mg once daily (if eGFR decreased by >30%, maintain dose at 10mg) or maintain at 20mg if current dose is 20mg once daily.
Children
<18yrs: not established.
Kerendia Contraindications
Contraindications
Concomitant strong CYP3A4 inhibitors (eg, itraconazole). Adrenal insufficiency.
Kerendia Boxed Warnings
Not Applicable
Kerendia Warnings/Precautions
Warnings/Precautions
Increased risk of hyperkalemia with decreasing kidney function and higher baseline K+ levels. Measure serum K+ and eGFR prior to initiation. Do not initiate if serum K+ is >5.0mEq/L. Measure serum K+ 4 weeks after initiation, periodically during treatment, and after dose adjustments. Severe hepatic impairment: avoid. Moderate hepatic impairment: consider more monitoring of serum K+. Pregnancy. Nursing mothers: not recommended (during and for 1 day after treatment).
Kerendia Pharmacokinetics
See Literature
Kerendia Interactions
Interactions
See Contraindications. Potentiated by strong CYP3A4 inhibitors. Avoid concomitant grapefruit or grapefruit juice. Potentiated by moderate or weak CYP3A4 inhibitors (eg, erythromycin, amiodarone); monitor and adjust dose appropriately. Antagonized by strong or moderate CYP3A4 inducers (eg, efavirenz, rifampicin); avoid. Concomitant with drugs or supplements that increase serum K+; monitor serum K+ more frequently.
Kerendia Adverse Reactions
Adverse Reactions
Hyperkalemia, hypotension, hyponatremia.
Kerendia Clinical Trials
See Literature
Kerendia Note
Not Applicable
Kerendia Patient Counseling
See Literature
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