Fincor 20 mg (Tablet)
Medicine Details
- Reduce risk of sustained eGFR decline
- Reduce risk of end-stage kidney disease
- Reduce risk of cardiovascular death
- Reduce risk of nonfatal myocardial infarction
- Reduce risk of hospitalization for heart failure
- For adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D)
- Nonsteroidal
- Selective antagonist of the mineralocorticoid receptor (MR)
- Blocks MR mediated sodium reabsorption
- MR overactivation in both epithelial and nonepithelial tissues
- High potency and selectivity for the MR
- No relevant affinity for androgen, progesterone, estrogen, and glucocorticoid receptors
- Mean systolic blood pressure decrease by 3 mmHg
- Mean diastolic blood pressure decrease by 1-2 mmHg
- Complete absorption after oral administration
- Undergoes metabolism resulting in absolute bioavailability of 44%
- Cmax achieved between 0.5 and 1.25 hours after dosing
- Exposure increased proportionally over a dose range of 1.25 to 80 mg
- Steady state achieved after 2 days of dosing
- Cmax was 160 µg/L and steady-state geometric mean AUCt,md was 686 µg.h/L following administration of finerenone 20 mg to patients
- Volume of distribution at steady-state (Vss) of finerenone is 52.6 L
- Plasma protein binding of finerenone is 92%
- Terminal half-life of finerenone is about 2 to 3 hours
- Systemic blood clearance is about 25 L/h
- Primarily metabolized by CYP3A4 (90%) and to a lesser extent by CYP2C8 (10%) to inactive metabolites
- About 80% of the administered dose is excreted in urine
- Recommended starting dosage: 10 mg or 20 mg orally once daily based on estimated glomerular filtration rate (eGFR) and serum potassium thresholds
- Increase dosage after 4 weeks to the target dose of 20 mg once daily, based on eGFR and serum potassium thresholds
- Tablets may be taken with or without food
- Dosage depends on eGFR levels
- Contraindicated with strong CYP3A4 inhibitors
- Monitor serum potassium during drug initiation or dosage adjustment with moderate or weak CYP3A4 inhibitors
- Avoid concomitant use with strong or moderate CYP3A4 inducers
- Contraindicated in concomitant use with strong CYP3A4 inhibitors
- Contraindicated in patients with adrenal insufficiency
- Adverse reactions include hyperkalemia, hypotension, and hyponatremia
- No available data for use in pregnancy
- Avoid breastfeeding during treatment and for 1 day after treatment
- Can cause hyperkalemia
- Measure serum potassium and eGFR before initiation of treatment
- Do not initiate if serum potassium is > 5.0 mEq/L
- Monitor serum potassium periodically during treatment
- Safety and efficacy not established in patients below 18 years of age
- No overall differences observed in patients 65 years and older
- Avoid use in patients with severe hepatic impairment (Child Pugh C)
- Suspected overdose may cause hyperkalemia
- Standard treatment should be initiated if hyperkalemia develops
- Unlikely to be efficiently removed by hemodialysis
- Mineralocorticoid Receptor Antagonists
- Keep below 30°C temperature
- Away from light & moisture
- Keep out of the reach of children
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