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Find information for healthcare professionals about Rituxan® (rituximab), the only FDA-approved treatment proven to induce remission in patients with GPA and MPA. INDICATION STATEMENT - Rituxan® (rituximab), in combination with glucocorticoids, is indicated for the treatment of adult patients with Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA) - Limitations of Use: Rituxan is not recommended for use in patients with severe, active infections BOXED WARNINGS and Additional Important Safety Information BOXED WARNINGS Infusion Reactions: Rituxan administration can result in serious, including fatal, infusion reactions. Deaths within 24 hours of Rituxan infusion have occurred. Approximately 80% of fatal infusion reactions occurred in association with the first infusion. Monitor patients closely. Discontinue Rituxan infusion for severe reactions and provide medical treatment for Grade 3 or 4 infusion reactions. Severe Mucocutaneous Reactions: Severe, including fatal, mucocutaneous reactions can occur in patients receiving Rituxan. Hepatitis B Virus (HBV) Reactivation: HBV reactivation can occur in patients treated with Rituxan, in some cases resulting in fulminant hepatitis, hepatic failure, and death. Screen all patients for HBV infection before treatment initiation, and monitor patients during and after treatment with Rituxan. Discontinue Rituxan and concomitant medications in the event of HBV reactivation. Progressive Multifocal Leukoencephalopathy (PML): PML, including fatal PML, can occur in patients receiving Rituxan. Warnings and Precautions Rituxan administration can also result in additional serious, including fatal, adverse reactions including: - Tumor lysis syndrome (TLS): Administer aggressive intravenous hydration, anti‑hyperuricemic agents, monitor renal function - Infections: Withhold Rituxan and institute appropriate anti-infective therapy - Cardiac arrhythmias and angina: Discontinue infusions in case of serious or life-threatening events - Bowel obstruction and perforation: Consider and evaluate for abdominal pain, vomiting, or related symptoms - Live virus vaccines: Do not administer live virus vaccines prior to or during Rituxan - Cytopenias: Monitor blood counts at regular intervals Granulomatosis With Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA) - Use of concomitant immunosuppressants other than corticosteroids has not been studied in GPA or MPA patients exhibiting peripheral B-cell depletion following treatment with Rituxan. Observe patients with GPA and MPA closely for signs of infection if immunosuppressants other than corticosteroids are used concomitantly - The safety and efficacy of retreatment with Rituxan have not been established in patients with GPA and MPA - Common adverse reactions (≥15%) in the clinical study were infections, nausea, diarrhea, headache, muscle spasms, anemia, and peripheral edema. Other important adverse reactions include infusion reactions You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555. For additional safety information, please see the Rituxan full prescribing information, including BOXED WARNINGS.

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