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Rituxan (rituximab) Injection
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
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 [see Warnings and Precautions (5.3), Adverse Reactions (6.1)].
5 WARNINGS AND PRECAUTIONS
5.3 Hepatitis B Virus (HBV) Reactivation
- Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure and death, can occur in patients treated with drugs classified as CD20-directed cytolytic antibodies, including Rituxan. Cases have been reported in patients who are hepatitis B surfaceantigen (HBsAg) positive and also in patients who are HBsAg negative but are hepatitis B coreantibody (anti-HBc) positive. Reactivation also has occurred in patients who appear to have resolved hepatitis B infection (i.e., HBsAg negative, anti-HBc positive and hepatitis B surface antibody [anti-HBs] positive).
- HBV reactivation is defined ............. Insufficient data exist regarding the safety of resuming Rituxan in patients who develop HBV reactivation. Resumption of Rituxan in patients whose HBV reactivation resolves should be discussed with physicians with expertise in managing hepatitis B.
Note: The text re: Tumor Lysis Syndrome was removed from the Boxed Warning
5 WARNINGS AND PRECAUTIONS
5.3 Severe Mucocutaneous Reactions
- Mucocutaneous reactions, some with fatal outcome, can occur in patients treated with Rituxan. These reactions include paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid dermatitis, vesiculobullous dermatitis, and toxic epidermal necrolysis. The onset of these reactions has been variable and includes reports with onset on the first day of Rituxan exposure. Discontinue Rituxan in patients who experience a severe mucocutaneous reaction. The safety of readministration of Rituxan to patients with severe mucocutaneous reactions has not been determined. [See Boxed Warning, Adverse Reactions (6, 6.1)]
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.