Budesonide Gains FDA Approval for IgA Nephropathy

The FDA has granted accelerated approval for Tarpeyo (budesonide) delayed release capsules to reduce proteinuria (increased protein levels in the urine) in adults with primary immunoglobulin A (IgA) nephropathy at risk of rapid disease progression. It has not been established whether Tarpeyo slows kidney function decline in patients with IgA nephropathy.

People who have allergic reactions to budesonide or any ingredients in Tarpeyo must not take the medication. Serious hypersensitivity reactions, including anaphylaxis (a severe, life-threatening allergic reaction) have occurred.

Tarpeyo is a corticosteroid and can cause side effects similar to other corticosteroids, which include hypercortisolism (high levels of the cortisol hormone) and adrenal suppression (not able to produce enough cortisol). Patients with moderate to severe liver impairment may be at increased risk of these side effects.

Tarpeyo is an immunosuppressant. As such, patients should not take Tarpeyo if they have tuberculosis; untreated fungal, bacterial, systemic viral or parasitic infections; or ocular herpes simplex (an eye infection). Patients taking Tarpeyo should avoid being exposed to active, easily transmitted infections. Corticosteroids, such as Tarpeyo, may decrease the immune response to some vaccines.

The most common side effects of Tarpeyo are high blood pressure; swelling in the lower legs and hands; muscle spasms; acne; skin irritation; weight increase; difficulty breathing; face swelling; indigestion; fatigue; and excess hair, often around the nose and mouth.