The FDA approved the first treatment for children with rare vasculitis diseases that cause inflammation of blood vessels and reduce blood flow to organs.
Genentech's Rituxan injections received orphan status to treat the diseases, granulomatosis with polyangiitis and microscopic polyangiitis, which can cause damage to the lungs, kidneys, sinuses and skin.
The treatment comes with a warning of increased risks for fatal infusion reactions, severe skin and mouth reactions and hepatitis B reactivation, among others.
The most common side effects of Rituxan are infections, infusion-related reactions, lymphopenia and anemia.
The FDA also advised physicians to monitor patients for tumor lysis syndrome, cardiac adverse reactions, damage to kidneys and bowel obstruction and perforation.
Read the FDA's full news release here.
More articles on pharmacy:
World Pharmacist Day promotes use of safe and effective medicines
USP delays release of updated compounding standards
Americans pay up to 67 times more for drugs than other countries.