- Details
- Description
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Packaging Size30t/bottle
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Strength400mg
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CompositonSparsentan
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TreatmentIgA Nephropathy
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FormTablet
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BrandLuciSeta
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Quantity Unit400mg*30t/Box
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ManufacturerLucius Pharmaceuticals (Lao) Co.,Ltd
Contents
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About Sparsentan
Sparsentan is a medication used for the treatment of primary immunoglobulin A nephropathy.Sparsentan is an endothelin and angiotensin II receptor antagonist.
IgA Nephropathy
Indicated to slow kidney function decline in adults with primaryimmunoglobulin A nephropathy (IgAN) who are at risk for disease progression
200 mg PO qDay initially; after 14 days, increase to recommended dose of 400 mg qDay, as tolerated
When resuming treatment after an interruption, consider starting at 200 mg/day, then after 14 days, increase to 400 mg/day
Dosage Modifications
ALT/AST >3x to ≤8x ULN
- Confirm elevation with repeat measure
- If confirmed, interrupt treatment, and monitor ALT/AST levels and bilirubin at least weekly, and INR as needed, until levels return to pretreatment values and the patient is asymptomatic
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Do not resume treatment if any of the following occurs without other cause found
- ALT/AST >3x ULN and total bilirubin >2x ULN or INR >1.5
- ALT/AST >3x ULN, with symptoms of fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, and/or eosinophilia (>5% eosinophils)
- ALT/AST >5x ULN for >2 weeks
- If treatment resumed, initiate at 200 mg qDay, with reassessment of hepatic enzyme levels and bilirubin within 3 days; close monitoring required in these patients
ALT/AST >8 x ULN
- Permanently discontinue if no other cause found
Coadministration of strong CYP3A4 inhibitors
- Avoid coadministration
- If use is unavoidable, interrupt sparsentan
Renal impairment
- Mild-to-moderate (eGFR 30-89 mL/min/1.73 m2): No clinically significant differences in pharmacokinetics observed
- Severe (eGFR <30 mL/min/1.73 m2): Not studied
Hepatic impairment
- Mild, moderate, or severe (Child-Pugh A-C): Avoid use with any hepatic impairment because of risk of serious liver injury
