Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Safety

  • Print
  • Share
  • E-mail
-

Rituxan (rituximab) Injection

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – October 2012

Summary View

 

ADVERSE REACTIONS

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

Pediatric Use
  • Hypogammaglobulinemia has been observed in pediatric patients treated with Rituxan.

 

-
-