司帕生坦说明书,医保,价格,疗效,副作用

Sparsentan is a new dual endothelin-angiotensin receptor antagonist, mainly used to treat proteinuria in patients with IgA nephropathy. The drug exerts a unique therapeutic effect by simultaneously blocking endothelin A receptors and angiotensin II type 1 receptors. It received accelerated approval from the US FDA in 2021.

Sparsentan Instructions

Correctly understanding the drug instructions is crucial for rational use. The following is the key information of the Sparsentan instructions.

Indications, Usage and Dosage

Sparsentan is approved to reduce proteinuria in adult patients with IgA nephropathy. The recommended starting dose is 200 mg orally once daily, which can be increased to a maintenance dose of 400 mg once daily after 4 weeks. The tablet should be swallowed whole and avoid breaking or chewing.

Important contraindications

Absolutely contraindicated during pregnancy as it may cause fetal malformations. It is contraindicated in patients with severe hepatic impairment. Concomitant use with strong CYP3A inhibitors is not recommended. Liver function, serum potassium and renal function need to be monitored regularly during medication.

After understanding the basic information about the drug, patients are most concerned about how to obtain the drug. Currently, sparsentan has not been approved for marketing in China.

Medical insurance and price of Sparsentan

The accessibility and economic burden of drugs directly affect treatment options. The following is the current medical insurance and price situation of Sparsentan.

International market price

The monthly treatment cost of Sparsentan (trade name Filspari) is about US$6,500-7,000. The price difference is due to different medical insurance policies in different countries.

Domestic acquisition methods

Since it has not yet been launched in China, it cannot be purchased through formal channels. Some patients obtain it through participation in international multi-center clinical trials or special import procedures, and must strictly follow relevant regulations.

While considering the cost of treatment, it is equally important to understand the actual efficacy of the drug.

Efficacy and Side Effects of Sparsentan

Evaluating the effect of treatment requires a balance between efficacy and risk of adverse reactions, and clinical research data provides an objective reference.

Clinical efficacy data

The key phase III study showed that the proteinuria of the sparsentan group was reduced after 9 months of treatment, which was significantly better than that of the control group. Long-term follow-up confirmed that it can continuously reduce proteinuria and delay the deterioration of renal function.

Common adverse reactions

Dizziness (18%), hypotension (12%), hyperkalemia (11%) and edema (10%) are common. About 5% of patients experience elevated ALT and require regular monitoring of liver function. Serious adverse reactions include acute kidney injury and hepatotoxicity.

Women of childbearing age must confirm that they are not pregnant before taking the medication, and take reliable contraceptive measures during treatment. Elderly patients and those with renal insufficiency need to adjust the dosage. During the medication, they should avoid driving or operating machinery until the individual response is clear.