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sparsentan

Filspari · ATC code C09XX01

Key facts
Active substance
sparsentan
ATC code
C09XX01
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Filspari 200 mg film-coated tablets / Filspari 400 mg film-coated tablets
Marketing authorisation holder
Vifor France
Information as of
2026-10-28

Key facts

Sparsentan (Filspari, film-coated tablets) is a dual endothelin and angiotensin II receptor antagonist. It is used for primary IgA nephropathy with proteinuria.

What it is used for

  • Adults with primary immunoglobulin A nephropathy with urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥ 0.75 g/g).

Dosing

  • Start at 200 mg once daily for 14 days, then a maintenance dose of 400 mg once daily depending on tolerability.
  • For tolerability issues (SBP ≤ 100 mmHg, diastolic ≤ 60 mmHg, worsening oedema, hyperkalaemia), adjust concomitant medicines, then temporarily down-titrate or discontinue.
  • Skip a missed dose; do not take double doses.
  • Not recommended in severe hepatic impairment; do not start if AST/ALT > 2 × ULN.

Contraindications

  • Hypersensitivity to the active substance or any of the excipients.
  • Pregnancy.
  • Coadministration of angiotensin receptor blockers, endothelin receptor antagonists or renin inhibitors.

Important warnings

  • In women of childbearing potential, start only once pregnancy is excluded and effective contraception is used.
  • Hypotension, reported more frequently in elderly patients.
  • Hyperkalaemia; do not start if serum potassium > 5.5 mmol/l.
  • Transaminase elevations; monitor liver tests before starting and every three months.

Side effects

  • Most common: hypotension (10.8 %), hyperkalaemia (9.6 %), dizziness (7.8 %) and peripheral oedema (5.4 %).
  • Others: anaemia, headache, orthostatic hypotension, renal impairment, fatigue, increased blood creatinine, elevated transaminases.
  • Most common serious reaction: acute kidney injury (0.9 %).

Interactions

  • Contraindicated with ARBs (e.g. losartan, valsartan), endothelin receptor antagonists (e.g. bosentan) and renin inhibitors (aliskiren).
  • Mineralocorticoid receptor inhibitors (e.g. spironolactone, finerenone) increase the risk of hyperkalaemia.
  • Strong CYP3A inhibitors (e.g. itraconazole, clarithromycin, grapefruit) are not recommended; consider interrupting sparsentan.

Pregnancy and breastfeeding

  • Contraindicated in pregnancy; effective contraception during and up to 1 month after treatment.
  • Should not be used during breastfeeding.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

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For patients

Package leaflet, verbatim

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

Source: European Medicines Agency (EMA), product information

Brand names in 3 more European countries
Iceland
Filspari
Liechtenstein
Filspari
Norway
Filspari

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

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Sources

  1. European Medicines Agency. Filspari – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/filspari-epar-product-information_en.pdf

Editorial: Medelix editorial team · last updated 2026-10-28 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.