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Sparsentan, as the first non-immunosuppressive therapy, provides a new treatment option for IgAN patients.
1. Generic name : Sparsentan (Sparsentan)
2. Trade name : FILSPARI™
3. Dosage form : Oral film-coated tablets
4 , Main ingredient :Each tablet contains sparsentan 200mg or 400mg (dihydrochloride form)
1 , IgA nephropathy (IgAN) : Used to reduce proteinuria in adults with primary IgA nephropathy (urinary protein to creatinine ratio UPCR ≥ 1.5g/g) and risk of rapid disease progression.
2. Restriction of : This indication is based on accelerated approval based on the reduction of proteinuria, and the delaying effect on renal function decline has not yet been proven.
1. Specifications :
200mg tablets: white to off-white oval film-coated tablets, with "105" engraved on one side.
400 mg tablet: White to off-white oval film-coated tablet, engraved with "021" on one side.
2. Packaging : 30 pieces per bottle, child-safe cap.
1. Initial dose of : 200mg once a day, take on an empty stomach or with food, swallow the whole tablet. After 14 days, increase to 400 mg once a day.
2. Treatment of missed doses : If the dose is missed for more than 6 hours, skip the dose; there is no need to take another dose after vomiting.
3. Dose adjustment :
(1). Liver injury : Reduced to 200mg/day for moderate (Child-PughB), and disabled for severe (Child-PughC).
(2) Abnormal liver function : Interrupt treatment when ALT/AST>3 times the upper limit of normal (ULN), and re-titrate from 200 mg after recovery.
1. Monitoring requirements :
Monitor ALT/AST and bilirubin every month before and during treatment (in the first 12 months), and every 3 months thereafter.
Women of childbearing age need monthly pregnancy tests.
2. Diet : Avoid high-fat meals (may increase absorption) and avoid grapefruit juice.
3. Drug interactions :
(1). Concomitant use of is prohibited: Angiotensin receptor blocker (ARB), endothelin receptor antagonist (ERA), aliskiren.
(2) Use with caution in combination with : Strong CYP3A inhibitors (such as itraconazole) need to interrupt spaxentan; NSAIDs may aggravate renal damage.
1. U200c for pregnant women: Absolute contraindications (animals show teratogenicity).
2. Lactation : Breastfeeding is prohibited during treatment and within 1 week after stopping the drug.
3. Children : Safety has not been established.
4. U200c for the elderly: No dose adjustment is required, but liver and kidney function need to be monitored.
1. Common (≥5%) : Peripheral edema (14%), hypotension (14%), dizziness (13%), hyperkalemia (13%), and anemia (5%).
2. Severe but rare : Hepatotoxicity (ALT/AST elevation), acute kidney injury, fluid retention.
1. Women who are pregnant or planning pregnancy.
2. Combined use of ARB, ERA or aliskiren.
3. Severe liver damage (Child-PughC).
1. CYP3A affects : Strong inhibitors increase spaxentan exposure by 174%, and strong inducers reduce it by 47%.
2. P-gp/BCRP substrate : It may increase the concentration of digoxin and other drugs, so combined use should be avoided.
3. Antacid : It needs to be taken 2 hours apart to avoid reducing the efficacy of the medicine.
Save at room temperature (20-25°C). The original bottle should be protected from light and moisture.