Indications

RITUXAN® (Rituximab) is indicated in combination with fludarabine and cyclophosphamide (FC chemotherapy) for the treatment of patients with:

• Previously untreated CD20-positive CLL
• Previously treated CD20-positive CLL

People with serious infections should not receive RITUXAN.

Important Safety Information

• RITUXAN can cause serious side effects that can lead to death, including: infusion reactions, tumor lysis syndrome (TLS; kidney failure due to fast breakdown of cancer cells), severe skin and mouth reactions, and progressive multifocal leukoencephalopathy (PML; a rare, serious brain infection).
• RITUXAN has also been associated with serious and life-threatening side effects, including: the return of active hepatitis B virus infection with sudden and serious liver problems including liver failure, and death, other serious infections that can lead to death, heart problems, kidney problems, and stomach and serious bowel problems including blockage and tears in the bowel that can sometimes lead to death.
• The most common side effects of RITUXAN seen in clinical trials of patients with CLL were infusion reactions and low white blood cells, which can increase the risk of infections. Before starting treatment with RITUXAN it is important for you to talk to your doctor about your medical history.
• Tell your doctor about any side effect that bothers you or that does not go away. These are not all of the possible side effects with RITUXAN. For more information, ask your doctor.

Please see full Prescribing Information, including Medication Guide, in PDF format.