Finotab10 mg

Finotab 10 mg is a non-steroidal mineralocorticoid receptor antagonist used to:

• Reduce the risk of sustained decline in kidney function, kidney failure (end-stage kidney disease), cardiovascular death, non-fatal heart attack, and hospitalization for heart failure in adults with chronic kidney disease (CKD) associated with type 2 diabetes
• In some regulatory approvals, reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adults with heart failure with mildly reduced or preserved ejection fraction

Finotab 10 mg is used as an addition to standard-of-care treatment, typically alongside a maximally tolerated dose of an ACE inhibitor or angiotensin receptor blocker (and, increasingly, alongside an SGLT2 inhibitor), rather than as a replacement for these therapies.

Contains Finotab 10 mg as the active ingredient, available as oral film-coated tablets in two strengths, 10 mg and 20 mg.

Finotab 10 mg is an oral medicine that blocks overactivation of the mineralocorticoid receptor, a pathway implicated in kidney and cardiovascular damage in patients with chronic kidney disease and type 2 diabetes. Unlike older mineralocorticoid receptor antagonists such as spironolactone, Finotab 10 mg is structurally distinct (non-steroidal), which is associated with a lower incidence of hormone-related side effects (such as breast tenderness or enlargement) while still carrying a meaningful risk of raised blood potassium (hyperkalemia), which requires monitoring throughout treatment.

Therapeutic Class: Nonsteroidal Mineralocorticoid Receptor Antagonist

Finotab 10 mg is almost completely metabolized by cytochrome P450 3A4 (CYP3A4), with a smaller contribution from CYP2C8, into inactive metabolites - this makes it highly sensitive to drugs that strongly inhibit or induce CYP3A4, which can substantially raise or lower Finotab 10 mg blood levels. It has a relatively short half-life, supporting once-daily dosing, and its dose is titrated based on both kidney function (eGFR) and serum potassium level, since both influence the balance between benefit and hyperkalemia risk.

• Taken orally, once daily, with or without food
• Swallow the tablet whole with water; if unable to swallow whole, the tablet may be crushed and mixed with water or soft food immediately before use, per the product's specific instructions
• Take at approximately the same time each day
• Do not increase the dose without your doctor's confirmation that your recent potassium and kidney function results support it

The following are important interactions, given Finotab 10 mg's dependence on CYP3A4 metabolism and its hyperkalemia risk:

• Strong CYP3A4 inhibitors (such as itraconazole, ketoconazole, clarithromycin, ritonavir): contraindicated in combination with Finotab 10 mg, since they can substantially raise Finotab 10 mg blood levels and toxicity risk.
• Moderate CYP3A4 inhibitors (such as erythromycin, diltiazem, verapamil, fluconazole): can also raise Finotab 10 mg levels; use with caution, and monitor potassium more closely if combined.
• Strong or moderate CYP3A4 inducers (such as rifampicin, phenytoin, carbamazepine, and efavirenz): can reduce Finotab 10 mg blood levels, reducing its effectiveness; concurrent use is generally avoided.
• Grapefruit and grapefruit juice: can increase Finotab 10 mg blood levels through CYP3A4 inhibition; avoid during treatment.
• Potassium-sparing diuretics, potassium supplements, and salt substitutes containing potassium: increase the risk of hyperkalemia when combined with Finotab 10 mg; avoid combining unless specifically directed and monitored by your doctor.
• Trimethoprim: increases the risk of hyperkalemia; temporary discontinuation of Finotab 10 mg or closer potassium monitoring may be needed if trimethoprim is required.
• NSAIDs: may increase the risk of kidney impairment and hyperkalemia when combined with Finotab 10 mg.

Common side effects

• Hyperkalemia (raised blood potassium) - the most common side effect, occurring in a meaningful proportion of patients
• Hypotension (low blood pressure)
• Hyponatremia (low blood sodium)

Serious side effects (seek urgent medical attention)

• Hyperkalemia: muscle weakness, tingling sensations, irregular heartbeat, or, in severe cases, cardiac arrest - hyperkalemia can be serious and, in some cases, has led to hospitalization; regular potassium monitoring is essential throughout treatment.
• Signs of significantly low blood pressure: severe dizziness, fainting, particularly when starting treatment or increasing the dose.
• Signs of a severe allergic reaction: rash, swelling, difficulty breathing.

Pregnancy

There are no available data on Finotab 10 mg use in human pregnancy; animal studies have shown embryonic toxicity at doses relevant to human exposure. Finotab 10 mg should generally be avoided during pregnancy unless the treating physician determines it is necessary, given limited safety data.

Breastfeeding

It is not known whether Finotab 10 mg passes into human milk; use during breastfeeding should be discussed with a healthcare professional, weighing the mother's treatment needs against any potential infant exposure.

• Hyperkalemia monitoring is essential: check serum potassium and eGFR before starting, approximately 4 weeks after starting or increasing the dose, and periodically thereafter based on individual patient characteristics and risk.
• Do not initiate in patients with a serum potassium above 5.0 mmol/L or an eGFR below 25 mL/min/1.73m².
• Withhold treatment if serum potassium exceeds 5.5 mmol/L, restarting only once it has fallen to 5.5 mmol/L or below, at the 10 mg dose.
• Avoid combining with potassium-sparing diuretics and other agents that raise potassium levels, given the additive hyperkalemia risk.
• Avoid grapefruit and grapefruit juice, and strong or moderate CYP3A4 inhibitors, given the risk of increased Finotab 10 mg exposure.
• Finotab 10 mg is not a substitute for standard-of-care therapy with an ACE inhibitor, ARB, or SGLT2 inhibitor; it is used in addition to, not instead of, these treatments.

Overdose would be expected to increase the risk of hyperkalemia and hypotension, the two principal known effects of Finotab 10 mg. Suspected overdose requires prompt medical evaluation, including measurement of serum potassium and blood pressure; treatment is generally supportive, and management of significant hyperkalemia follows standard emergency protocols, provided by the treating medical team.

Store at controlled room temperature (generally 20-25°C, with excursions permitted between 15-30°C), protected from moisture, in the original container.

• Severe renal impairment (eGFR below 25 mL/min/1.73m²): Not recommended to initiate treatment, given limited data and increased hyperkalemia risk.
• Hepatic impairment: No dose adjustment recommended for mild or moderate impairment (Child-Pugh A or B); not studied in severe impairment (Child-Pugh C), and use is generally avoided in this population.
• Elderly: No specific dose adjustment based on age alone, though monitoring for hyperkalemia and hypotension applies as in any patient, and elderly patients may have reduced renal reserve.

Finotab 10 mg is used as ongoing, long-term therapy alongside standard-of-care treatment for chronic kidney disease associated with type 2 diabetes (and, where approved, certain heart failure indications), for as long as it is tolerated and clinically beneficial, with regular monitoring of kidney function and serum potassium throughout treatment.

Drug Class: Selective, nonsteroidal mineralocorticoid receptor antagonist

Finotab 10 mg blocks the mineralocorticoid receptor, which, when overactivated (as can occur in chronic kidney disease and heart failure), contributes to inflammation, fibrosis (scarring), and damage in the kidney and cardiovascular system. By blocking this receptor, Finotab 10 mg helps slow the progression of kidney damage and reduces the risk of certain cardiovascular complications in patients with type 2 diabetes and chronic kidney disease, working through a different, complementary pathway to ACE inhibitors, ARBs, and SGLT2 inhibitors.

Safety and effectiveness of Finotab 10 mg have not been established in patients younger than 18 years, and it is not recommended for use in children.