Drug Detail:Filspari (Sparsentan)
Generic Name: SPARSENTAN 200mg
Dosage Form: tablet, film coated
Drug Class: Miscellaneous cardiovascular agents
2.1 General Consideration
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)].
2.2 Monitoring
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)].
2.3 Recommended Dosage
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)].
2.4 Administration
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.
2.5 Dosage Adjustment for Aminotransferase Elevations
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.
| ALT = alanine aminotransferase; AST = aspartate aminotransferase; INR = international normalized ratio; ULN = upper limit of normal. | ||
| 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:
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. | |
