Orville
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Finerenone Orville 1Finerenone Orville 2

Finerenone Orville

Composition: Finerenone

Form: Film-coated tablets

Indications: Reduction of the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease associated with type 2 diabetes.

Contraindications: Hypersensitivity to finerenone or excipients, concomitant treatment with strong CYP3A4 inhibitors, Addison's disease.

Dosage: Target dose: 20 mg once daily. Starting dose depends on eGFR: 20 mg once daily if eGFR is at least 60 mL/min/1.73 m2, 10 mg once daily if eGFR is 25 to less than 60 mL/min/1.73 m2. The product is not recommended if eGFR is below 25 mL/min/1.73 m2. Serum potassium and eGFR should be checked before treatment and again 4 weeks after initiation or dose adjustment.

Side effects: Hyperkalemia, hypotension, hyponatremia.

Interactions: Do not use together with potassium-sparing diuretics or other mineralocorticoid receptor antagonists. Use with caution and monitor serum potassium when combined with potassium supplements, trimethoprim, or trimethoprim/sulfamethoxazole.

Warnings: Serum potassium and eGFR should be assessed before treatment. Therapy should not be started if serum potassium is above 5.0 mmol/L. Potassium should be monitored regularly during treatment; if it rises above 5.5 mmol/L, therapy should be temporarily interrupted.

Age restrictions: Adults 18 years and older only.

Pregnancy: There are no adequate data on use during pregnancy or breastfeeding. Use in these periods is not recommended without a physician's benefit-risk assessment.

Country of origin: Bangladesh

Manufacturer: Incepta Pharmaceuticals Ltd.

Storage conditions: Store below 30 °C. Keep out of reach of children.