Previously untreated diffuse large B-cell, CD20-positive NHL in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens.Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy.
INDICATIONS Non–Hodgkin’s Lymphoma (NHL) Each mL of solution contains 10 mg rituximab, polysorbate 80 (0.7 mg), sodium chloride (9 mg), sodium citrate dihydrate (7.35 mg), and Water for Injection, USP. RITUXAN is supplied at a concentration of 10 mg/mL in either 100 mg/10 mL or 500 mg/50 mL single-dose vials. RITUXAN (rituximab) injection is a sterile, preservative-free, clear, colorless solution for intravenous infusion. Gentamicin is not detectable in the final product. Rituximab is produced by mammalian cell (Chinese Hamster Ovary) suspension culture in a nutrient medium that may contain the antibiotic gentamicin. Rituximab has an approximate molecular weight of 145 kD. Rituximab is a genetically engineered chimeric murine/human monoclonal IgG 1 kappa antibody directed against the CD20 antigen. Progressive Multifocal Leukoencephalopathy (PML), including fatal PML, can occur in patients receiving RITUXAN. Discontinue RITUXAN and concomitant medications in the event of HBV reactivation. Screen all patients for HBV infection before treatment initiation, and monitor patients during and after treatment with RITUXAN. HBV reactivation can occur in patients treated with RITUXAN, in some cases resulting in fulminant hepatitis, hepatic failure, and death. Severe, including fatal, mucocutaneous reactions can occur in patients receiving RITUXAN.
Discontinue RITUXAN infusion for severe reactions and provide medical treatment for Grade 3 or 4 infusion-related reactions. Approximately 80% of fatal infusion reactions occurred in association with the first infusion. Deaths within 24 hours of RITUXAN infusion have occurred. RITUXAN administration can result in serious, including fatal, infusion-related reactions. You may report side effects to FDA at 1-80.įATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY Infusion-Related Reactions For more information, ask your doctor or pharmacist.Ĭall your doctor for medical advice about side effects. These are not all the possible side effects of Rituxan. Tell the doctor if you have any side effect that bothers you or that does not go away.
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