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Another NamePS-433540, RE-021, DARA-a, 斯帕森坦,司帕生坦
IndicationsIt is indicated for slowing the decline in renal function in adult patients with primary immunoglobulin A nephropathy (IgAN) who are at risk of disease progression.
Reg No.10 L 1036/23
Inspection NO.2582-23
This drug was granted accelerated approval for marketing by the U.S. FDA in February 2023. Targeting the endothelin A receptor (ETAR) and angiotensin II type 1 receptor (AT1R), it is a prescription drug and must be used strictly in accordance with medical advice.
Endothelin A Receptor (ETAR), Angiotensin II Type 1 Receptor (AT1R).
Route and frequency of administration for Sparsentan: The initial dose is 200 mg, taken orally once daily.
The dosage of Sparsentan shall be adjusted according to the patient's actual condition; for specific circumstances, patients should consult a doctor and follow the medical advice strictly.
Recommended Reading: Dosage and Administration of Sparsentan
Key Risks and Warnings: Hepatotoxicity, Embryo-fetal toxicity.
Serious Adverse Reactions: Hepatic disorders, severe birth defects, hypotension, etc.
Common Adverse Reactions: Swelling of the hands, legs, ankles and feet (peripheral edema), dizziness, decreased red blood cells (anemia), etc.
Reference Article: Adverse Reactions of Sparsentan
Pregnancy: Sparsentan is contraindicated during pregnancy, as its use by pregnant women may cause fetal harm. For patients of childbearing potential, pregnancy must be excluded before initiating Sparsentan treatment.
1. Patients are advised to read the patient medication information (medication guide) approved by the U.S. Food and Drug Administration (FDA).
2. Patients are advised to take Sparsentan with water once daily, either before breakfast or before dinner, and maintain a consistent dosing schedule relative to meals. If a dose is missed, patients should take the next scheduled dose at the regular time; do not take a double dose or an additional supplementary dose.
3. If patients develop symptoms associated with hepatotoxicity (e.g., nausea, vomiting, right upper abdominal pain, fatigue, anorexia, jaundice, dark-colored urine, fever, pruritus), they should immediately discontinue Sparsentan and seek medical attention.
from FDA，2023.02
