Diabetes:
Indications for: KERENDIA
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.
Adult Dosage:
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 Dosage:
<18yrs: not established.
KERENDIA Contraindications:
Concomitant strong CYP3A4 inhibitors (eg, itraconazole). Adrenal insufficiency.
KERENDIA 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 Classification:
Nonsteroidal mineralocorticoid receptor antagonist (MRA).
KERENDIA 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.
Adverse Reactions:
Hyperkalemia, hypotension, hyponatremia.
Generic Drug Availability:
NO
How Supplied:
Tabs—30, 90
Miscellaneous urogenital disorders:
Indications for: KERENDIA
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.
Adult Dosage:
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 Dosage:
<18yrs: not established.
KERENDIA Contraindications:
Concomitant strong CYP3A4 inhibitors (eg, itraconazole). Adrenal insufficiency.
KERENDIA 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 Classification:
Nonsteroidal mineralocorticoid receptor antagonist (MRA).
KERENDIA 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.
Adverse Reactions:
Hyperkalemia, hypotension, hyponatremia.
Generic Drug Availability:
NO
How Supplied:
Tabs—30, 90
