Fatal Infusion Reaction

• Rituximab administration can result in serious, including fatal reactions.
• Deaths within 24 hrs of infusion have been occurred.
• Approximately 80% of fatal infusion reactions occurred in association with the first infusion. Carefully monitor patients during infusion.
• Discontinue rituximab infusions and provide medical treatment for Grade 3 or 4 infusions [See Warnings and Precautions, Adverse Reactions].

Tumor Lysis Syndrome (TLS)

• Acute renal failure requiring dialysis with instances of fatal outcome can occur in the setting of TLS following treatment of non-Hodgkin's lymphoma (NHL) patients with Rituxan. (See WARNINGS and PRECAUTIONS, ADVERSE REACTIONS.)

Mucocutaneous Reactions (Severe)

• Severe, including fatal, mucocutaneous reactions can occur in patients receiving Rituxan treatment. (See WARNINGS and PRECAUTIONS, and ADVERSE REACTIONS.)

Progressive Multifocal Leukoencephalopathy (PML)

• JC virus infection resulting in PML and death has been reported in patients treated with Rituxan. (See WARNINGS and ADVERSE REACTIONS.)

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.

Patient Counseling Information

• Rituxan

Package Inserts

Rituximab