Lucius LuciSeta Sparsentan 200mg

Product Information

• Product name: LuciSeta Sparsentan 200mg
• Manufacturer / brand: Laos Lucius Pharma
• Active ingredient: Sparsentan
• Current strength: 200mg
• SKU: LU-ITEM-106
• Site category: proteinuria, other cancer

Product Summary

LuciSeta Sparsentan 200mg is an AISTIKA-listed product supplied by Laos Lucius Pharma. This page summarizes the product identity, strength, SKU, site category, and public medical reference information. Product name, manufacturer, packaging, and strength follow this AISTIKA product page.

Active Ingredient and Reference Data

Sparsentan is the active ingredient used for this product page. Public prescribing information for Sparsentan was used for the medical reference sections. Medical details are provided for reference and must be interpreted by a qualified healthcare professional.

Mechanism of Action

Sparsentan is a single molecule with antagonism of the endothelin type A receptor (ET A R) and the angiotensin II type 1 receptor (AT 1 R). Sparsentan has high affinity for both the ET A R (Ki= 12.8 nM) and the AT 1 R (Ki=0.36 nM), and greater than 500-fold selectivity for these receptors over the endothelin type B and angiotensin II subtype 2 receptors. Endothelin 1 and angiotensin II are thought to be involved in the pathogenesis of IgAN and FSGS via the ET A R and AT 1 R, respectively.

Reference Indications

Sparsentan is an endothelin and angiotensin II receptor antagonist indicated: To slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression ( 1.1 , 12.1 , 14.1 ).

Reference Dosage and Administration

Recommended dose and titrating to the recommended dose after 14 days . swallow tablets whole with water prior to the morning or evening meal .

Dose conversion must be confirmed by a physician because the reference dose may vary by indication, organ function, toxicity, or interacting medicines.

This reference dosage is not an individualized prescription. Dose changes, treatment interruptions, or discontinuation must be directed by a physician.

Important Safety Information

WARNING: HEPATOTOXICITY and EMBRYO-FETAL TOXICITY Because of the risk of hepatotoxicity, Sparsentan is available only through a restricted program called the Sparsentan REMS. Under the Sparsentan REMS, prescribers, patients, and pharmacies must enroll in the program . Hepatotoxicity Some Endothelin Receptor Antagonists (ERAs) have caused elevations of aminotransferases, hepatotoxicity, and liver failure. Measure transaminases and bilirubin before initiating treatment and then every 3 months during treatment. Interrupt treatment and closely monitor patients who develop aminotransferase elevations more than 3-times ULN .

Common Adverse Reactions and Monitoring

IgAN The safety of Sparsentan was evaluated in PROTECT ( NCT03762850 ), a randomized, double-blind, active-controlled clinical study in adults with IgAN. The data below reflect Sparsentan exposure in 202 patients with a median duration of 110 weeks. Sparsentan (N = 202) n (%) Irbesartan (N = 202) n (%) Hyperkalemia 1 34 27 Hypotension (including orthostatic hypotension) 33 13 Peripheral edema 1 33 29 Dizziness 1 32 14 Anemia 16 9 Acute kidney injury 12 5 Transaminase elevations 2 7 8 FSGS The safety of Sparsentan was evaluated in DUPLEX ( NCT03493685 ), a randomized, double-blind, active-controlled clinical study in adult and pediatric patients with FSGS .

Drug Interactions and Special Populations

Strong CYP3A inhibitors: Avoid concomitant use. Increased sparsentan exposure ( 2.7 , 7.2 , 12.3 ). Increased sparsentan exposure ( 7.2 , 12.3 ). Strong CYP3A inducers: Avoid concomitant use. Decreased sparsentan exposure ( 7.3 , 12.3 ). Non-steroidal anti-inflammatory drugs (NSAIDs) including selective cyclooxygenase (COX-2) inhibitors: Monitor for signs of worsening renal function. Increased risk of kidney injury . CYP2B6, 2C9, and 2C19 substrates: Monitor for substrate efficacy. Decreased exposure of these substrates ( 7.5 , 12.3 ). Increased exposure to substrates ( 7.6 , 12.3 ). Agents Increasing Serum Potassium: Increased risk of hyperkalemia, monitor serum potassium frequently ( 5.6 , 7.7 ).

Storage and Purchase Notes

Store according to the package or pharmacist instructions and keep out of reach of children. Before ordering, confirm product name, strength, quantity, price, shipping details, and payment method. After receipt, check packaging, batch number, expiration date, and storage conditions.

Sources

Sources: FILSPARI public prescribing information; openFDA/DailyMed public label data. These sources are used for public medical reference. Product information follows this AISTIKA product page.

DisclaimerThis page is for product information and public-label reference only. It does not provide diagnosis, prescription, or individualized medical advice. Consult a physician for treatment decisions.