Finished product reference

Finerenone

Tablet · Oral · 10 mg

List code
53636
Pharmacologic class
Non-steroidal selective mineralocorticoid receptor antagonist

What it is and how it works

Finerenone is a non-steroidal, selective antagonist of the mineralocorticoid receptor that blocks receptor-mediated sodium reabsorption and mineralocorticoid receptor overactivation in kidney, heart and blood vessels. This reduces inflammation and fibrosis, slows decline in kidney function and reduces albuminuria.

Indications

Chronic kidney disease (with albuminuria) associated with type 2 diabetes in adults, to reduce the risk of kidney function decline and cardiovascular events; in some regions also heart failure with left ventricular ejection fraction of 40% or more.

Dosage and administration (summary)

Oral, once daily; the starting dose (10 mg or 20 mg) depends on eGFR, with titration to the target dose of 20 mg once daily (or 40 mg in heart failure where approved) according to serum potassium and eGFR monitoring.

Contraindications

Concomitant strong CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, clarithromycin, ritonavir), Addison’s disease, and hypersensitivity.

Warnings and precautions

Hyperkalaemia is the main risk; serum potassium and eGFR must be measured before starting, at 4 weeks and periodically thereafter, and treatment withheld if potassium exceeds the threshold in the product information. Avoid strong or moderate CYP3A4 inducers and grapefruit, and use caution with potassium supplements, other potassium-sparing drugs and severe hepatic impairment.

Pregnancy

Not recommended in pregnancy unless clearly necessary; women of child-bearing potential should use effective contraception.

Storage and supply

No special temperature storage conditions; keep in the original package.

Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.

Other presentations of the same active ingredient

Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.

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