Fatal Infusion Reaction; Mucocutaneous Reactions; Progressive Multifocal Leukoencephalopathy; Hep b Reactivation
- Rituximab 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 [see Warnings and Precautions (5.1), Adverse Reactions (6.1)].
Severe Mucocutaneous Reactions
- Severe, including fatal, mucocutaneous reactions can occur in patients receiving Rituxan [see Warnings and Precautions (5.2), Adverse Reactions (6)].
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)].
Progressive Multifocal Leukoencephalopathy (PML),
- Progressive Multifocal Leukoencephalopathy (PML) including fatal PML, can occur in patients receiving Rituxan [see Warnings and Precautions (5.4),Adverse Reactions (6)].
MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA
- If severe infusion reaction occurs, stop treatment and initiate management (see package insert for details)
- Tumor lysis syndrome have been reported within 12 to 24 hours after the first infusion.
- Onset of mucocutaneous reactions has ranged from one to 13 weeks.
FDA and Industry Communications
Patient Counseling Information
Patient Medication Guide - RIABNI
Patient Medication Guide - RITUXAN
Patient Medication Guide - RITUXAN HYCELA
Patient Medication Guide - TRUXIMA
Patient Medication Guide - RUXIENCE
Updated September 2022