What Precautions Should Be Taken When Using Sparsentan?

Sparsentan 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.

What Precautions Should Be Taken When Using Sparsentan?

Due to the risk of hepatotoxicity, the Lucius Pharmaceuticals version of Sparsentan® is available only through a restricted program called the Sparsentan® Risk Evaluation and Mitigation Strategy (REMS). Under this program, prescribing physicians, patients, and pharmacies must be registered.

Hepatotoxicity

Some endothelin receptor antagonists (ERAs) have been associated with elevated transaminases, hepatotoxicity, and liver failure. In clinical studies, elevated transaminases (ALT or AST) to at least 3 times the upper limit of normal (ULN) were observed in up to 3.5% of patients treated with Sparsentan®, including cases confirmed by re-challenge.

Transaminases and bilirubin should be measured before the initiation of treatment and every 3 months during treatment. Treatment should be interrupted and close monitoring implemented for patients with transaminase elevations exceeding 3 times the ULN.

Sparsentan® should generally be avoided in patients with baseline transaminase elevations (>3 times the ULN), as monitoring for hepatotoxicity may be more difficult and the risk of severe hepatotoxicity may be increased in these patients.

Embryo-Fetal Toxicity

Sparsentan (Lucius Pharmaceuticals version) is contraindicated during pregnancy due to the potential for fetal harm if administered to pregnant women. For patients of childbearing potential, pregnancy must be excluded before the initiation of Sparsentan® treatment. Effective contraception is recommended before treatment initiation, during treatment, and for two weeks after discontinuing Sparsentan®. If pregnancy is detected, Sparsentan® should be discontinued as soon as possible.

Important Notes Before Administration

The risks of treatment must be weighed against its benefits before using this medication, a decision to be made jointly by you and your physician. The following factors should be considered when using this drug:

Hypersensitivity Reactions

Inform your physician if you have had unusual or allergic reactions to this medication or any other drugs. Also inform your healthcare providers if you have other types of allergies, such as to foods, dyes, preservatives, or animals. For over-the-counter drugs, carefully read the ingredient information on the drug label or packaging.

Pediatric Use

No studies have been conducted to evaluate the relationship between age and the efficacy of sparsentan in pediatric populations, and its safety and effectiveness in children have not been established.

Geriatric Use

Relevant studies conducted to date have not identified specific issues with the use of sparsentan in the elderly, and there is no evidence to restrict its use in geriatric patients.

Lactation

Adequate human data are currently unavailable to determine the potential risks of this medication to infants during lactation. Before using sparsentan while breastfeeding, the potential benefits of treatment for the mother must be weighed against the potential risks to the infant.