Medication Monitor

Generic Name (Trade Name—Company)
October 2, 2019


Rituximab approved as first treatment for children with rare vasculitis diseases

FDA approved rituximab injection in combination with glucocorticoids to treat granulomatosis with polyangiitis and microscopic polyangiitis in children ages 2 years and older.

It is the first approved treatment for children with these rare vasculitis diseases, in which a patient’s small blood vessels become inflamed, reducing the amount of blood that can flow through them. This can cause serious problems and damage to organs, most notably the lungs and kidneys. It also can impact the sinuses and skin.

Rituximab's most common adverse effects are infections, infusion-related reactions, lymphopenia, and anemia. Health professionals are advised to monitor patients for tumor lysis syndrome, cardiac adverse reactions, renal toxicity, and bowel obstruction and perforation.

The prescribing information includes a boxed warning of fatal infusion reactions; potentially fatal severe skin and mouth reactions; hepatitis B virus reactivation, which may cause serious liver problems, including liver failure and death; and progressive multifocal leukoencephalopathy, a rare, serious brain infection that can result in severe disability or death.

Rituximab must be dispensed with a patient Medication Guide that provides important information about the drug’s uses and risks.

The agent was approved to treat adult patients with GPA and MPA in 2011. It is also approved to treat four additional diseases, first gaining approval to treat non-Hodgkin's lymphoma in 1997.