Resources for You
Rituxan (rituximab) Injection
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – October 2012
Clinical Trials Experience in Granulomatosis with Polyangiitis (GPA) (Wegener’sGranulomatosis) and Microscopic Polyangiitis (MPA).
- Hypogammaglobulinemia (IgA, IgG or IgM below the lower limit of normal) has been observed in patients with GPA and MPA treated with Rituxan. At 6 months, in the Rituxan group, 27%, 58% and 51% of patients with normal immunoglobulin levels at baseline, had low IgA, IgG and IgM levels, respectively compared to 25%, 50% and 46% in the cyclophosphamide group.
USE IN SPECIFIC POPULATIONS
- Hypogammaglobulinemia has been observed in pediatric patients treated with Rituxan.