Sparsentan: clinical use

Prescribing considerations

• Specialist initiation is appropriate for adults meeting the licensed proteinuria criterion.
• Reconcile existing renin–angiotensin and endothelin-system treatments before initiation.
• Assess hypotension, volume status, fluid retention, heart failure, hepatic impairment and kidney-transplant history.
• Clinical experience is limited in severe kidney disease; initiation is not recommended during dialysis.
• The product is under additional monitoring.

Contraindications and cautions

• Hypersensitivity to sparsentan or an excipient
• Pregnancy
• Concomitant angiotensin receptor blocker
• Concomitant endothelin receptor antagonist
• Concomitant renin inhibitor
• Rare hereditary galactose intolerance, total lactase deficiency or glucose–galactose malabsorption

Monitoring

• Verify absence of pregnancy and review contraception where relevant.
• Measure blood pressure and assess fluid status.
• Check kidney function and serum potassium before and during treatment, with closer review in higher-risk patients.
• Check aminotransferases and total bilirubin before treatment and every three months; investigate symptoms of hepatic injury.
• Review proteinuria and overall kidney trajectory to assess response.

Clinical pharmacology

Sparsentan is a non-immunosuppressive, dual high-affinity antagonist of endothelin type A and angiotensin II type 1 receptors. It is primarily metabolised through CYP3A and can also affect several CYP pathways.

Formulation and product differences

• Filspari is authorised as 200 mg and 400 mg film-coated tablets.
• The strengths have different tablet sizes and identifying debossing.
• Both strengths contain lactose and are swallowed whole with water.

Tablet

Route: Oral

Strengths: 200 mg