Sparsentan/sparsentan Chinese instructions

1. Common name:Sparsentan

Product name:Filspari

Other names: sparsentine, sparsentine, sparsentine (transliteration)

2. Who can take sparsentan? Indications?

Sparsentan slows the decline in kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression.

3. What are the side effects of Sparsentane?

Common side effects of sparsentan include hyperkalemia, hypotension (including orthostatic hypotension), peripheral edema, dizziness, anemia, acute kidney injury, and elevated transaminases; use of sparsentan may cause an initial small decrease in estimated glomerular filtration rate (eGFR) within the first 4 weeks of treatment, followed by stabilization.

4. How should you take sparsentan?

1. Before use: Before starting sparsentan treatment, the use of renin-angiotensin-aldosterone system (RAAS) and endothelin receptor antagonists (ERA) should be stopped.

2. Medication monitoring: Before starting sparsentan treatment, transaminase levels and total bilirubin must be measured. Initiation of treatment should be avoided in patients with transaminase elevations greater than 3 times the upper limit of normal (ULN). After discontinuation of treatment due to elevated transaminases, monitoring is required monthly for the next 12 months and every 3 months while on sparsentane.

3. Recommended dosage: During initial treatment, take 200 mg sparsentane orally daily. After 14 days, the dose may be increased to the recommended daily dose of 400 mg based on tolerance. If sparsentane is restarted after an interruption in treatment, consideration should be given to titration starting with 200 mg once daily and increasing to the recommended dose of 400 mg once daily after 14 days.

4. Medication management: It is recommended that patients swallow sparsentan tablets with water in the morning or evening before meals, and maintain the same dosage pattern as meals. If you miss a dose, take the next dose at the next regularly scheduled time, but no double or extra doses.

5. How to store Sparsentine?

SparsentintoSupplied in bottles of 30 film-coated tablets, 200 mg, 400 mg, store at 20°C to 25°C (68°F to 77°F), excursions allowed within the temperature range of 15°C to 30°C (59°F to 86°F). Store sparsentin in its original container.

6. How does Spasentin work?

Sparsentane is a single-molecule compound that antagonizes endothelin type A receptor (ETAR) and angiotensin II type 1 receptor (AT1R). The compound shows high affinity for both ETAR (Ki=12.8 nM) and AT1R (Ki=0.36 nM), and its selectivity is more than 500 times higher than endothelin type B receptor and angiotensin II subtype 2 receptor. Endothelin 1 and angiotensin II are believed to play important roles in the pathogenesis of IgAN through ETAR and AT1R respectively.

7. What will happen if you overdose on sparsentan?

There is currently no experience with overdosage with Sparsentan. Healthy volunteers take sparsentane at doses up to 1600 mg/day, and patients with IgAN take sparsentane at doses up to 400 mg/day. Overdose of sparsentane may cause a drop in blood pressure. In case of overdose, standard supportive measures should be instituted as needed. Dialysis is unlikely to be effective because sparsentine is highly bound to proteins.

8. Who cannot use Sparsentine?

Sparsentin is contraindicated in pregnant women. Do not take sparsentane with an ARB, ERA, or aliskiren.

Reference materials:https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d7354af1-f304-f4d9-e053-2995a90ab219