Rituxan Indications and Important Safety Information
INDICATION
RITUXAN® (rituximab) is indicated for the treatment of patients with:
Relapsed or refractory, low-grade or follicular CD20-positive, B-cell NHL as a single agent
| o Weekly x 4 | o Weekly x 8 | o Bulky disease | o Retreatment |
- Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to RITUXAN in combination with chemotherapy, as a single-agent maintenance therapy
- Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line CVP chemotherapy
- Previously untreated diffuse large B-cell, CD20-positive NHL in combination with CHOP or other anthracycline-based chemotherapy regimens
- Previously untreated CD20-positive CLL in combination with FC chemotherapy
- Previously treated CD20-positive CLL in combination with FC chemotherapy
RITUXAN is not recommended for use in patients with severe, active infections.
Important Safety Information
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WARNING: FATAL INFUSION REACTIONS, TUMOR LYSIS SYNDROME (TLS), SEVERE MUCOCUTANEOUS REACTIONS, and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML) Infusion Reactions: RITUXAN 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. Carefully monitor patients during infusions. Discontinue RITUXAN infusion and provide medical treatment for Grade 3 or 4 infusion 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) with RITUXAN monotherapy. Severe Mucocutaneous Reactions: Severe, including fatal, mucocutaneous reactions can occur in patients receiving RITUXAN. Progressive Multifocal Leukoencephalopathy (PML): JC virus infection resulting in PML and death can occur in patients receiving RITUXAN. |
Warnings and Precautions
RITUXAN has also been associated with other serious and/or fatal adverse reactions. These include:
- Hepatitis B reactivation with fulminant hepatitis, hepatic failure resulting in death
- Serious, including fatal, bacterial, fungal and new or reactivated viral infections
- Cardiovascular events including serious or life-threatening cardiac arrhythmias
- Severe, including fatal, renal toxicity
- Abdominal pain, bowel obstruction and perforation, in some cases leading to death, can occur in patients receiving RITUXAN in combination with chemotherapy.
Additional Important Safety Information
- The most common adverse reactions of RITUXAN (incidence ≥25%) observed in clinical trials of patients with NHL were infusion reactions, fever, lymphopenia, chills, infection, and asthenia. The most frequent Grade 3 or 4 adverse reactions observed in NHL were cytopenias including lymphopenia
- The most common adverse reactions of RITUXAN (incidence ≥25%) observed in clinical trials of patients with CLL were infusion reactions and neutropenia. Most patients treated with R-FC experienced at least one Grade 3 or 4 adverse reaction. The most frequently reported Grade 3 or 4 adverse reaction was neutropenia
In clinical trials, CLL patients 70 years of age and older who received R-FC had more Grade 3 and 4 adverse reactions compared with younger CLL patients who received the same treatment.
You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.
For additional safety information, please see the full prescribing information, including BOXED WARNINGS and Medication Guide.