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Rituxan

"The U.S. Food and Drug Administration today approved Rituxan (rituximab) to treat certain patients with chronic lymphocytic leukemia (CLL), a slowly progressing blood and bone marrow cancer.

Rituxan, an anti-cancer drug, is intended fo"...

Rituxan

Rituxan®
(rituximab) Injection for IV Use‎

Rituxan

WARNING

FATAL INFUSION REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY

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. Monitor patients closely. Discontinue Rituxan infusion for severe reactions and provide medical treatment for Grade 3 or 4 infusion reactions [see WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS].

Severe Mucocutaneous Reactions

Severe, including fatal, mucocutaneous reactions can occur in patients receiving Rituxan [see WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS].

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, ADVERSE REACTIONS].

Progressive Multifocal Leukoencephalopathy (PML), including fatal PML, can occur in patients receiving Rituxan [see WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS].

DRUG DESCRIPTION

Rituxan® (rituximab) is a genetically engineered chimeric murine/human monoclonal IgG1 kappa antibody directed against the CD20 antigen. Rituximab has an approximate molecular weight of 145 kD. Rituximab has a binding affinity for the CD20 antigen of approximately 8.0 nM.

Rituximab is produced by mammalian cell (Chinese Hamster Ovary) suspension culture in a nutrient medium containing the antibiotic gentamicin. Gentamicin is not detectable in the final product. Rituxan is a sterile, clear, colorless, preservative-free liquid concentrate for intravenous administration. Rituxan is supplied at a concentration of 10 mg/mL in either 100 mg/10 mL or 500 mg/50 mL single-use vials. The product is formulated in polysorbate 80 (0.7 mg/mL), sodium citrate dihydrate (7.35 mg/mL), sodium chloride (9 mg/mL) and Water for Injection. The pH is 6.5.

What are the possible side effects of rituximab (Rituxan)?

Some people receiving a rituximab injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, weak, nauseated, light-headed, itchy, or if you have a fever, chills, muscle pain, sneezing, sore throat, trouble breathing, or pain in your chest or shoulders. Infusion reactions often occur within the first 24 hours after the start of your rituximab infusion.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips,...

Read All Potential Side Effects and See Pictures of Rituxan »

What are the precautions when taking rituximab (Rituxan)?

Before using rituximab, tell your doctor or pharmacist if you are allergic to it; or to other mouse protein medications; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood disorders (e.g., thrombocytopenia), heart problems (e.g., irregular heartbeat, angina), current or returning infections, lung problems (e.g., pulmonary infiltrates), previous severe reaction to monoclonal antibody treatment, virus infection (e.g., chickenpox, hepatitis B or C, herpes, JC virus).

This drug may make you dizzy. Do not drive, use machinery, or do any activity that...

Read All Potential Precautions of Rituxan »

Last reviewed on RxList: 10/21/2013
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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