Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Vifor France, 100–101 Terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris La Défense Cedex, France
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, see section 5.1).
Sparsentan 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.
For titration from the initial dose of 200 mg once daily to the maintenance dose of 400 mg once daily, 200 mg and 400 mg film-coated tablets are available to achieve the maintenance dose.
If patients experience tolerability issues (systolic blood pressure [SBP] ≤100 mmHg, diastolic blood pressure ≤60 mmHg, worsening edema, or hyperkalaemia), adjustment of concomitant medicinal products, followed by temporary down–titration or discontinuation of sparsentan is recommended (see sections 4.4 and 5.1).
When resuming treatment with sparsentan after interruption, repeating the initial dosing schedule may be considered. Interruption of treatment preceded, or not by dose reduction of sparsentan, may be considered based on persisting hypotension or changes in liver function (see section 4.4).
If a dose is missed, the dose should be skipped and the next dose is to be taken at the regularly scheduled time. Double or extra doses should not be taken.
No dose adjustment is recommended in elderly patients (see section 5.2). In elderly patients sparsentan treatment should be initiated at a dose of 200 mg once daily for 14 days. The increase to a maintenance dose of 400 mg once daily should be performed with caution, based on tolerability (see section 4.4).
Based on pharmacokinetics data, no dose adjustment of sparsentan is required in patients with mild or moderate hepatic impairment (Child-Pugh A or Child-Pugh B classification; see section 5.2).
There is limited clinical experience with moderate hepatic impairment. Therefore, sparsentan should be used with caution in these patients (see section 4.4).
Sparsentan has not been studied in patients with severe hepatic impairment (Child-Pugh C classification) and is therefore not recommended for use in these patients.
There is limited clinical experience with aspartate aminotransferase (AST)/alanine aminotransferase (ALT) values more than two times the upper limit of the normal range (ULN). Therefore, sparsentan should not be initiated in patients with AST/ALT > 2 × ULN (see section 4.4).
No dose adjustment is required in patients with mild (chronic kidney disease [CKD] stage 2; estimated glomerular filtration rate [eGFR] 60 to 89 mL/min/1.73 m²) or moderate (CKD stages 3a and 3b; eGFR 30 to 59 mL/min/1.73 m²) kidney disease. Based on pharmacokinetic data, no dose adjustment can be recommended for patients with severe kidney disease (CKD stage 4; eGFR <30 mL/min/1.73 m²) (see section 5.2). As there is limited clinical experience in patients with severe kidney disease, sparsentan is not recommended in these patients (see section 4.4).
Sparsentan has not been studied in patients who have received a kidney transplant, therefore sparsentan should be used with caution is these patients.
Sparsentan has not been studied in patients undergoing dialysis. Initiation of sparsentan is not recommended in these patients.
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.
Oral use.
It is recommended to swallow the tablets whole with water to avoid bitter taste. Sparsentan can be taken with or without food.
Sparsentan has been administered in doses of up to 1600 mg/day in healthy subjects without evidence of dose limiting toxicities. Patients who experience overdose (possibly experiencing signs and symptoms of hypotension) should be monitored closely and appropriate symptomatic treatment given.
4 years.
This medicinal product does not require any special storage conditions.
High-density polyethylene (HDPE) bottle with child-resistant polypropylene cap.
Pack size of 30 film-coated tablets.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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