Fincor 10 mg (Tablet)

Medicine Details

Fincor is indicated to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, nonfatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D).
Finerenone is a nonsteroidal, selective antagonist of the mineralocorticoid receptor (MR), which is activated by aldosterone and cortisol and regulates gene transcription. Finerenone blocks MR mediated sodium reabsorption and MR overactivation in both epithelial (e.g., kidney) and nonepithelial (e.g., heart, and blood vessels) tissues. MR overactivation is thought to contribute to fibrosis and inflammation.

The 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.
Recommended Dosage: - eGFR ≥60 mL/min/1.73 m²: starting dose 20 mg once daily - eGFR ≥25 to <60 mL/min/1.73 m²: starting dose 10 mg once daily - eGFR <25 mL/min/1.73 m²: not recommended For patients who are unable to swallow whole tablets, Finerenone may be crushed and mixed with water or soft foods.

Strong CYP3A4 Inhibitors: Fincor is a CYP3A4 substrate. Concomitant use with a strong CYP3A4 inhibitor increases Fincor exposure, which may increase the risk of Fincor adverse reactions. Concomitant use of Fincor with strong CYP3A4 inhibitors is contraindicated. Avoid concomitant intake of grapefruit or grapefruit juice.
Moderate and Weak CYP3A4 Inhibitors: Fincor is a CYP3A4 substrate. Concomitant use with a moderate or weak CYP3A4 inhibitor increases Fincor exposure, which may increase the risk of Fincor adverse reactions. Monitor serum potassium during drug initiation or dosage adjustment of either Fincor or the moderate or weak CYP3A4 inhibitor, and adjust Fincor dosage as appropriate.
Strong and Moderate CYP3A4 Inducers: Fincor is a CYP3A4 substrate. Concomitant use of Fincor with a strong or moderate CYP3A4 inducer decreases Fincor exposure, which may reduce the efficacy of Fincor. Avoid concomitant use of Fincor with strong or moderate CYP3A4 inducers.

Contraindicated in concomitant use with strong CYP3A4 inhibitors & patients with adrenal insufficiency.

Adverse reactions occurring in ≥ 1% of patients on Fincor and more frequently than placebo are hyperkalemia, hypotension, and hyponatremia.

There are no available data on Fincor 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 4 times those expected in humans.
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 4 times the AUC unbound expected in humans.

Fincor can cause hyperkalemia. 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.

Pediatric Use: The safety and efficacy of Fincor have not been established in patients below 18 years of age.
Geriatric Use: Of the 2827 patients who received Fincor in the FIDELIO-DKD study, 58% of patients were 65 years and older, and 15% were 75 years and older. No dose adjustment is required.
Hepatic Impairment: Avoid use of Fincor 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).

In the event of suspected overdose, immediately interrupt Fincor treatment. The most likely manifestation of overdose is hyperkalemia. If hyperkalemia develops, standard treatment should be initiated. Fincor is unlikely to be efficiently removed by hemodialysis given its fraction bound to plasma proteins of about 90%.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.