Dosing & Administration
One tablet, once daily. One molecule addressing two critical pathways involved in IgAN disease progression1
SWITCH & START FILSPARI now for significant, rapid, and sustained proteinuria reduction in a non-immunosuppressive foundation of care1,2
200 or 400 mg tablets
With or without food
1x daily
Only initiate FILSPARI in verified
absence of pregnancy and
while on effective contraception
Switch from RASi and up-titrate to maintenance dose1
Contraindications:1
- Hypersensitivity to the active substance(s) or to any of the excipients
- Pregnancy
- Coadministration of angiotensin receptor blockers (ARBs), endothelin receptor antagonists (ERAs), or renin inhibitors
Suitable for chronic use1,2
References & footnotes
Footnotes
*Prior to starting treatment with FILSPARI, discontinue use of ARBs, ERAs, or renin inhibitors. 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. In women of childbearing potential, verify the absence of pregnancy prior to initiation/use of effective contraception1
†Treatment with FILSPARI 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. If patients experience tolerability issues (systolic BP ≤100 mmHg, diastolic BP ≤60 mmHg, worsening edema, or hyperkalemia), adjustment of concomitant medicinal products, followed by temporary down-titration or discontinuation of FILSPARI, is recommended1
Abbreviations
ARB, angiotensin II receptor blocker; BP, blood pressure; ERA, endothelin receptor antagonist; IgA, immunoglobulin A; IgAN, immunoglobulin A nephropathy; MoA, mechanism of action; RASi, renin-angiotensin system inhibitor
References
- FILSPARI. EU SmPC. April 2024.
- Rovin B, et al. Efficacy and safety of sparsentan versus irbesartan in patients with IgA nephropathy (PROTECT): 2-year results from a randomised, active-controlled, phase 3 trial. Lancet. 2023;402(10417):2077–90.
- Campbell KN, et al. Practical Considerations for the Use of Sparsentan in the Treatment of Patients with IgAN in Clinical Practice. Int J Nephrol Renovasc Dis. 2023;16:281–91.
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 has been granted a conditional marketing authorization by the European Commission.
▼ 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 CSL Vifor 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.
Vifor France. 100–101 Terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris La Défense Cedex, France
Date of preparation: April 2024 | API job number: HQ-SPT-2400059
HQ-SPT-2500004 | Date of preparation: February 2025