What are the side effects of sparsentan?

Adverse reactions in sparsentan trials

Because clinical trials are conducted under a variety of different conditions, the incidence of adverse reactions observed in the clinical trials of one drug cannot be directly compared with the incidence in the clinical trials of another drug, nor may it reflect the incidence observed in practice.

The safety of Sparsentan (FILSPARI) 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 73 weeks (up to 110 weeks). The most common adverse reactions are listed in Table 2.

Table 1: Adverse reactions occurring in ≥2% of treated subjects1

1Data presented include all reported treatment-emergent adverse events

2ALT or AST elevation >3×ULN reported as an adverse event of concern

sparsentan (sparsentan) laboratory testing

Initiating sparsentan treatment may result in an initial small decrease in estimated glomerular filtration rate (eGFR) that occurs within the first 4 weeks of starting treatment and then stabilizes.

The incidence of hemoglobin decreases >2 g/dL from baseline and below the lower limit of normal was higher in the sparsentan group (11%) than in the irbesartan group (5%). This decrease is thought to be due in part to blood thinning. There were no treatment discontinuations due to anemia or decreased hemoglobin in the PROTECT study.

Have blood tests to check your liver before treatment with sparsentan, once a month for the first 12 months, and then every 3 months during treatment. If your liver function test results change, your healthcare provider may temporarily stop or permanently stop sparsentan treatment.

Call your doctor right away if any of the following signs of liver problems occur during treatment with sparsentan: nausea or vomiting, yellowing of the skin or white parts of the eyes (jaundice), pain in the upper right side of the stomach, tiredness, dark "tea-colored" urine, loss of appetite, fever, itching.

The most common side effects of sparsentan include: swelling of the hands, legs, ankles, and feet (peripheral edema), low red blood cells (anemia), and dizziness.

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