Safety
Safety profile of FILSPARI1
The most common adverse drug reactions observed during clinical trials1*
Hypotension 9%
Hyperkalemia 7%
Dizziness 7%
Peripheral edema 5%
The most common serious adverse reaction reported was acute kidney injury (1%)1
TEAEs were well-balanced between FILSPARI and irbesartan, except for dizziness and hypotension2†
References & footnotes
Footnotes
*Supportive safety data were obtained from 27 clinical trials that involved more than 500 patients exposed to FILSPARI in chronic kidney disease population, including IgAN and FSGS1
†The efficacy and safety of FILSPARI has been evaluated in PROTECT in patients with IgAN. In PROTECT, adverse events were well-balanced between treatment groups, except for dizziness (15% with FILSPARI vs 6% with irbesartan) and hypotension (13% with FILSPARI vs 4% with irbesartan)2
Abbreviations
FSGS, focal segmental glomerulosclerosis; IgA, immunoglobulin A; IgAN, immunoglobulin A nephropathy; K+, potassium; MoA, mechanism of action; TEAE, treatment-emergent adverse event
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.
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-2500003 | Date of preparation: February 2025