For full prescribing information refer to the Summary of Product Characteristics (SmPC). Name of the medicinal product: Filspari 200 mg film-coated tablets; Filspari 400 mg film-coated tablets. Filspari (sparsentan) 200 mg/400 mg film-coated, essentially sodium-free tablets with known-effect lactose excipient. Indication: Filspari is indicated for the treatment of adults with primary immunoglobulin A nephropathy (IgAN) with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.75 g/g). Dosage and administration: Filspari treatment should be initiated at a dose of 200 mg once daily for 14 days and then increased to a maintenance dose of 400 mg once daily, dependent upon tolerability. It is recommended to swallow the tablets whole with water to avoid bitter taste. Filspari can be taken with or without food. If patients experience tolerability issues (systolic blood pressure ≤100 mmHg, diastolic blood pressure ≤60 mmHg, worsening oedema, or hyperkalaemia), adjustment of concomitant medicinal products, followed by temporary down-titration or discontinuation of Filspari is recommended. When resuming treatment with Filspari after interruption, repeating the initial dosing schedule may be considered. Interruption of treatment preceded, or not, by dose reduction of Filspari may be considered based on persisting hypotension or changes in liver function. No dose adjustment is recommended in elderly patients, patients with mild or moderate hepatic impairment, and patients with mild or moderate kidney disease. Due to lack of clinical experience, Filspari should not be initiated in patients with aspartate aminotransferase (AST) or alanine amino transferase (ALT) more than two times the upper limit of normal (ULN). The safety and efficacy of Filspari in children below the age of 18 years with IgAN have not yet been established. No data are available. Contraindications: Filspari is contraindicated in patients with hypersensitivity to sparsentan or to any of its excipients. Filspari is contraindicated during pregnancy. Do not co-administer Filspari with angiotensin receptor blockers, endothelin receptor antagonists, or renin inhibitors. Special warnings and precaution: Pregnancy: Filspari treatment must only be initiated in women of childbearing potential when the absence of pregnancy has been verified. Women of childbearing potential have to use effective contraception during and up to 1 month after treatment has stopped. Breastfeeding: Filspari should not be used during breastfeeding as it may be excreted in human milk and a risk to newborns/infants cannot be excluded. Hypotension: Hypotension has been associated with the use of renin-angiotensin-aldosterone system (RAAS) inhibitors, including Filspari. In patients at risk for hypotension, eliminating or adjusting other antihypertensive medicinal products and maintaining appropriate volume status should be considered. If hypotension develops despite elimination or reduction of other antihypertensive medicinal products, dose reduction or dose interruption of Filspari should be considered. A transient hypotensive response is not a contraindication to further dosing of Filspari; treatment can be resumed once blood pressure has stabilised. Impaired kidney function: RAAS inhibitors have been associated with a transient increase in serum creatinine, which may occur especially when initiating treatment with Filspari. Periodic monitoring of serum creatinine and serum potassium levels should be performed in patients at risk. Filspari should be used with caution in patients with bilateral renal artery stenosis. Filspari is not recommended in patients with an estimated glomerular filtration rate <30 mL/min/1.73m2. Fluid retention: Fluid retention has been associated with medicinal products that antagonise the endothelin type A receptor, including Filspari. If fluid retention develops during treatment with Filspari, treatment with diuretics is recommended, or the dose of existing diuretics should be increased before modifying the dose of Filspari. Filspari has not been studied in patients with heart failure. Liver function: Elevations in ALT or AST of at least 3 times ULN have been observed with Filspari. No concurrent elevations in bilirubin >2 x ULN or cases of liver failure have been observed in Filspari-treated patients. To reduce the risk of potential serious hepatotoxicity, serum aminotransferase levels and total bilirubin should be monitored prior to initiation of treatment and then continue monitoring every 3 months. If patients develop sustained, unexplained, clinically significant ALT and/or AST elevation, or if elevations are accompanied by an increase in bilirubin >2 × ULN, or if ALT and/or AST elevation is accompanied by signs or symptoms of hepatic injury (e.g. jaundice), Filspari therapy should be discontinued. Consider re-initiation of Filspari only when hepatic enzyme levels and bilirubin return to pretreatment values and only in patients without clinical symptoms of hepatotoxicity. Hyperkalaemia: Treatment should not be initiated in patients with serum potassium level >5.5 mmol/L. As with other medicinal products that affect the renin-angiotensin-aldosterone system, hyperkalaemia may occur during the treatment with Filspari, especially in the presence of renal impairment and/or heart failure. Close monitoring of serum potassium in patients at risk is recommended. If patients experience clinically significant hyperkalaemia (>5.5 mmol/l), adjustment of concomitant medicinal products, or temporary down-titration or discontinuation is recommended. Hepatic impairment: In a dedicated study, Filspari exposure was similar in patients with mild or moderate hepatic impairment compared to patients with normal hepatic function. No dose adjustment is required in patients with mild or moderate hepatic impairment, but should be used with caution in patients with moderate hepatic impairment. No data is available in patients with severe hepatic impairment and is therefore not recommended. Dialysis: Filspari is not recommended in patients undergoing dialysis as it has not been studied in this population. Undesirable effects: The most commonly reported adverse drug reactions were hypotension (10.8%), hyperkalaemia (9.6%), dizziness (7.8%), and peripheral oedema (5.4%). The most common serious adverse reaction reported was acute kidney injury (0.9%). Pharmacodynamic properties: Pharmacotherapeutic group: agents acting on the renin-angiotensin system, ATC code: C09XX01. List of excipients: Tablet core: Microcrystalline cellulose, lactose, sodium starch glycolate (type A), colloidal anhydrous silica, magnesium stearate; Film coating: Poly(vinyl alcohol), macrogol, talc, titanium dioxide (E171).

Filspari is contraindicated during pregnancy. Filspari treatment must only be initiated in women of childbearing potential when the absence of pregnancy has been verified. Women of childbearing potential have to use effective contraception during and up to 1 month after treatment has stopped.

▼ This medicinal product is subject to additional monitoring. This will allow identification of new safety information. This SmPC may be updated from time to time as necessary. Healthcare professionals are asked to report any suspected adverse reactions. Adverse events should also be reported to Vifor Pharma at safety@viforpharma.com Medicinal product subject to restricted medical prescription. Full prescribing information is available on request. Please read the full SmPC prior to administration. Filspari® is a registered trademark.

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Date of preparation: April 2025 | API job number: MED-HQ-SPT-2500032

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