Source: FDA, National Drug Code (US) Revision Year: 2023
FILSPARI is indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/g.
This indication is approved under accelerated approval based on a reduction of proteinuria [see Clinical Studies (14)]. It has not been established whether FILSPARI slows kidney function decline in patients with IgAN. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial.
Prior to initiating treatment with FILSPARI, discontinue use of renin-angiotensin-aldosterone system (RAAS) inhibitors, endothelin receptor antagonists (ERAs), and aliskiren [see Contraindications (4), Drug Interactions (7.1)].
Initiate treatment with FILSPARI only after measuring aminotransferase levels and total bilirubin. Avoid initiation in patients with elevated aminotransferases (>3x ULN). Continue required monitoring monthly for the first 12 months after initiation or restarting following an interruption due to elevated transaminases, then every 3 months during treatment with FILSPARI [see Dosage and Administration (2.2, 2.3, 2.5), Warnings and Precautions (5.1)].
Initiate treatment with FILSPARI in patients who can become pregnant only after confirmation of a negative pregnancy test. Pregnancy tests are required monthly during treatment and one month after discontinuation of treatment with FILSPARI [see Warnings and Precautions (5.2), Use in Specific Populations (8.1, 8.3)].
Initiate treatment with FILSPARI at 200 mg orally once daily. After 14 days, increase to the recommended dose of 400 mg once daily, as tolerated. When resuming treatment with FILSPARI after an interruption, consider titration of FILSPARI, starting at 200 mg once daily. After 14 days, increase to the recommended dose of 400 mg once daily [see Drug Interactions (7.2)].
Instruct patient to swallow tablets whole with water prior to the morning or evening meal. Maintain the same dosing pattern in relationship to meals. If a dose is missed, take the next dose at the regularly scheduled time. Do not take double or extra doses.
If aminotransferase levels increase, adjust monitoring and treatment plan according to Table 1.
Do not resume treatment in patients who have experienced clinical symptoms of hepatotoxicity or in patients whose hepatic enzyme levels and bilirubin have not returned to pretreatment levels.
Table 1. Dosage Adjustment and Monitoring in Patients Developing Aminotransferase Elevations >3x ULN:
| ALT/AST levels | Treatment and monitoring recommendations |
|---|---|
| >3x and ≤8x ULN | Confirm elevation with a repeat measure. If confirmed, interrupt treatment, and monitor aminotransferase levels and bilirubin at least weekly, and INR as needed, until the levels return to pretreatment values and the patient is asymptomatic. Do not resume treatment if any of the following occurs without other cause found: • ALT or AST >3x ULN and total bilirubin >2x ULN or INR >1.5 • ALT or AST >3x ULN, with symptoms of fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, and/or eosinophilia (>5% eosinophils) • ALT or AST >5x ULN for more than 2 weeks If treatment is resumed, initiate FILSPARI at 200 mg once daily, with reassessment of hepatic enzyme levels and bilirubin within 3 days. Close monitoring is required in these patients [see Dosage and Administration (2.2, 2.3)]. |
| >8x ULN | Stop treatment permanently if no other cause found. |
ALT = alanine aminotransferase; AST = aspartate aminotransferase; INR = international normalized ratio; ULN = upper limit of normal.
Avoid concomitant use of strong CYP3A inhibitors with FILSPARI.
If a strong CYP3A inhibitor cannot be avoided, interrupt treatment with FILSPARI [see Drug Interactions (7.2)].
There is no experience with overdose with FILSPARI. Sparsentan has been given in doses up to 1600 mg/day in healthy volunteers, or up to 400 mg/day in patients. Overdose of FILSPARI may result in decreased blood pressure. In the event of an overdose, standard supportive measures should be taken, as required. Dialysis is unlikely to be effective because sparsentan is highly protein-bound.
Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Store FILSPARI in its original container.
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