Information about FIGARDIA

Composition:
Each film coated tablet contains: 10 mg or 20 mg of Finerenone.
Pharmacokinetics:
Absorption:
Finerenone is completely absorbed after oral administration but undergoes metabolism resulting in absolute bioavailability of 44 %. Finerenone Cmax was achieved between 0.5 and 1.25 hours after dosing.
Effect of Food:
There was no clinically significant effect on finerenone AUC following administration with high fat, high calorie food.
Distribution:
The volume of distribution at steady-state (Vss) of finerenone is 52.6 L. Plasma protein binding of finerenone is 92 %, primarily to serum albumin, in vitro.
Elimination:
The terminal half-life of finerenone is about 2 to 3 hours, and the systemic blood clearance is about 25 L/h. 
Metabolism:
Finerenone is primarily metabolized by CYP3A4 (90 %) and to a lesser extent by CYP2C8 (10 %) to inactive metabolites. 
Excretion:
About 80 % of the administered dose is excreted in urine (< 0.2% as unchanged).
Indications:
Finerenone 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).
Contraindications:
Finerenone is contraindicated in patients: Who are receiving concomitant treatment with strong CYP3A4 inhibitors. With adrenal insufficiency.
Adverse Reactions:
The following serious adverse reactions are discussed elsewhere in the labeling:
• Hyperkalemia The most frequently reported (≥ 10%) adverse reaction was hyperkalemia, Hypotension ,and Hyponatremia.
Storage Conditions:
Do not store above 30° C.
Keep out of the reach of children. 
Packaging: 
Carton pack of 30 film coated tablets in blisters for both strengths.