What is the correct usage and dosage of sparsentan?

Initiate treatment with (sparsentan, FILSPARI), 200 mg PO once daily. After 14 days, increase to the recommended dose of 400 mg once daily as tolerated.

About sparsentan

Phase III clinical studies have shown that sparsentan is not only a dual-target antihypertensive drug, but also can reduce proteinuria in patients with primary immunoglobulin A nephropathy due to rapid disease progression, and effectively reduce proteinuria in patients with immunoglobulin A nephropathy (IgAN) and focal segmental glomerulosclerosis. Compared with irbesartan, it is the first non-immunosuppressive drug to reduce IgAN proteinuria. In 2023, sparsentan was approved by the FDA and launched in the United States.

Recommended dosage of sparsentan

Initiate treatment with FILSPARI, 200 mg once daily. After 14 days, increase to the recommended dose of 400 mg once daily as tolerated. When reinitiating FILSPARI therapy after an interruption, consideration should be given to titrating FILSPARI starting at 200 mg once daily. After 14 days, increase to the recommended dose of 400 mg once daily.

How to administer sparsentan

Instruct patients to swallow the tablets whole with water before breakfast or dinner. Maintain the same dosing pattern as with meals. If you miss a dose, take the next dose at the regularly scheduled time. Do not take a double dose or extra dose.

General precautions for sparsentan

Discontinue renin-angiotensin-aldosterone system (RAAS) inhibitors, endothelin receptor antagonists (ERA), and aliskiren before initiating treatment with FILSPARI.

Sparsentan monitoring

1. Initiate FILSPARI treatment for bilirubin only after measuring transaminase levels and total bilirubin.

2. Patients with elevated transaminases (> 3x ULN) should avoid initiating treatment.

3. Monitoring needs to be continued monthly during the first 12 months after starting treatment, or restarted after treatment is interrupted due to elevated transaminases, and then every 3 months during FILSPARI treatment.

4. Patients who are pregnant can only start FILSPARI treatment after confirming a negative pregnancy test. Monthly pregnancy tests are required during treatment with FILSPARI and for 1 month after stopping treatment.

Sparsentan drug interactions

1. Renin-angiotensin system (RAS) inhibitors and ERA

Do not use FILSPARI with ARB, ERA, or aliskiren. The combined use of these drugs is associated with an increased risk of hypotension,

Syncope, hyperkalemia, and changes in renal function (including acute renal failure).

2. Strong and moderate CYP3A inhibitors

Avoid coadministration of FILSPARI with strong CYP3A inhibitors. If strong CYP3A inhibitors cannot be avoided, FILSPARI treatment should be interrupted. Consider dose titration when resuming FILSPARI therapy.

3. Strong CYP3A inducer

Avoid coadministration with strong CYP3A inducers. Sparsentan is a CYP3A substrate. Coadministration with strong CYP3A inducers may decrease the Cmax and AUC of sparsentan, potentially reducing the efficacy of FILSPARI.

4. Antacids and acid-reducing agents

Give FILSPARI 2 hours before or 2 hours after antacid administration. Avoid coadministration of FILSPARI with acid-reducing agents (histamine H2 receptor antagonists and PPI proton pump inhibitors).

5. Nonsteroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors

Monitor for signs of worsening renal function during concomitant use of NSAIDs, including selective COX-2 inhibitors.

6. CYP2B6, 2C9 and 2C19 substrates

Monitor the efficacy of concomitantly administered CYP2B6, 2C9, and 2C19 substrates and consider dosage adjustments according to prescribing information. Sparsentan is an inducer of CYP2B6, 2C9 and 2C19. Sparsentan may reduce exposure to these substrates, which may reduce the efficacy associated with these substrates.

7. P-gp and BCRP substrates

Avoid coadministration of P-gp and BCRP sensitive substrates with FILSPARI. Sparsentan is an inhibitor of P-gp and BCRP. Sparsentan may increase the exposure of these transporter substrates, which may increase the risk of adverse reactions associated with these substrates.

8. Drugs that increase serum potassium

Serum potassium should be monitored frequently in patients receiving FILSPARI and other drugs that may increase serum potassium. Concomitant use of FILSPARI with potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, or other drugs that increase serum potassium levels may result in hyperkalemia.

Recommended hot articles: