Rituxan (Rituximab); Tirgan.com:"Rituxan is the first of monoclonal antibodies to become commercially available for treatment of Low Grade Lymphomas. This is a rather well tolerated drug that has shown reasonable efficacy against certain lymphomas. Rituxan is an antibody that selectively binds to CD-20 antigen on the surface of lymphoma cells. CD-20 is present in over 90% of low grade lymphomas. This drug also depletes normal CD-20 lymphocytes as well. Clinical trials with this drug have shown almost 50% response in patients who had have failed a prior chemotherapy and had progressive and refractory lymphoma. This drug is given intravenously, on a weekly basis for four weeks. The infusion should be slow and may be given in an out patient setting. Pre-medications with Tylenol and Benadryl should be used to prevent potential allergic reaction to this drug. The first infusion is usually takes about 4-6 hours and may be associated with side effects as mentioned bellow. These side effects may be due to the destruction of both normal and malignant Lymphoma cells and release of substances from inside these cells. The subsequent infusions are better tolerated and may be associated with less side effects and can be given over 2-4 hours. Fever, Chills may happen in majority of patients and can be helped with using Tylenol prior to the administration of the drug. Nausea, vomiting, Fatigue, Skin Rash, Low blood pressure, Asthma and shortness on breath\Low White blood counts, Low platelet counts, Fluid retention, Destruction of normal lymphocytes does not seem to be associated with increased risk of infections."
http://www.tirgan.com/rituxan.htm

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Rituxan (Rituximab); Rituxan.com:"WARNINGS Fatal Infusion Reactions: Deaths within 24 hours of RITUXAN infusion have been reported. These fatal reactions followed an infusion reaction complex which included hypoxia, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation or cardiogenic shock. Approximately 80% of fatal infusion reactions occurred in association with the first infusion. (See WARNINGS and ADVERSE REACTIONS in full Prescribing Information.) Patients who develop severe infusion reactions should have RITUXAN infusion discontinued and receive medical treatment. Tumor Lysis Syndrome (TLS): Acute renal failure requiring dialysis with instances of fatal outcome has been reported in the setting of TLS following treatment with RITUXAN. (See WARNINGS in full Prescribing Information.) Severe Mucocutaneous Reactions: Severe mucocutaneous reactions, some with fatal outcome, have been reported in association with RITUXAN treatment."
http://www.rituxan.com/rituxan/professional/pro_index.htm

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Rituxan (Rituximab); lymphomainfo.net:"Rituxan (generic name Rituximab, British trade name MabThera) is a newer monoclonal antibody for follicular or refractory low grade NHL. It has received FDA approval in the United States, approval in the UK, and is being approved by other countries. How it works:Ninety percent of B-cell lymphomas (lymphomas where the cancerous cell is the B lymphocyte) have a site on them called the CD20 antigen. This is like a puzzle piece, waiting for a molecular linkup with another substance. IDEC Pharmaceuticals developed the anti CD20 antibody IDEC-C2B8 which links up to the antigen site on the B-cell. This allows the developed drug Rituxan to target B lymphocytes and not other cells in the body which do not have the CD20 antigen site. Effectiveness:In trials, researchers found that almost 50% of patients responded to the treatment with full or partial remission. Side Effects:Most effects are felt during the first treatment - attention should be made to the rate of antibody infusion. Fevers, chills, respiratory symptoms, and occasionally hypertension are the most common effects. The effects overall are much more mild than comparable traditional chemotherapy agents. Further Study:Researchers are studying the combination of Rituxan with other treatments (such as CHOP chemotherapy) for better effectiveness (see video section below). IDEC is currently testing Zevalin, a combination of Rituxan and the radioisotope yttrium-90. Manufacturers:Genentech http://www.gene.com/ E-mail medinfo@gene.com Hotline: +1 (800) 821-8590 Address: 1 DNA Way, South San Francisco, CA 94080-4990. IDEC Pharmaceuticals Corporation 11011 Torreyana Road, San Diego, CA 92121 +1 (619) 550-8656"
http://www.lymphomainfo.net/therapy/immunotherapy/rituxan.html

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Rituxan (Rituximab); rituxan-oncology.com:"The RITUXAN (Rituximab) antibody is a genetically engineered chimeric murine/human monoclonal antibody directed against the CD20 antigen found on the surface of normal and malignant B lymphocytes. The antibody is an IgG1 kappa immunoglobulin containing murine light- and heavy- chain variable region sequences and human constant region sequences. Rituximab is composed of two heavy chains of 451 amino acids and two light chains of 213 amino acids (based on cDNA analysis) and has an approximate molecular weight of 145 kD. Rituximab has a binding affinity for the CD20 antigen of approximately 8.0 nM. The chimeric anti-CD20 antibody 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. The anti-CD20 antibody is purified by affinity and ion exchange chromatography. The purification process includes specific viral inactivation and removal procedures. Rituximab drug product is manufactured from either bulk drug substance manufactured by Genentech, Inc. (US License No. 1048), or utilizing formulated bulk Rituximab supplied by IDEC Pharmaceuticals Corporation (US License No. 1235) under a shared manufacturing arrangement. RITUXAN is a sterile, clear, colorless, preservative-free liquid concentrate for intravenous (IV) 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 for IV administration in 9.0 mg/mL sodium chloride, 7.35 mg/mL sodium citrate dihydrate, 0.7 mg/mL polysorbate 80, and Sterile Water for Injection. The pH is adjusted to 6.5."
http://www.rituxan-oncology.com/page2.shtml

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Rituxan (Rituximab); cancer-info.com:"Low grade non-Hodgkins lymphoma (NHL) cells are not easy to spot by your cancer-fighting immune system. Rituxan works by attaching a biological "flag", called a monoclonal antibody, to proteins which are on the surface of the lymphoma cells. This makes it easier for your immune system to find the lymphoma cells and destroy them.This process is called biological response therapy or immunotherapy. The treatment acts by stimulating your body's own abililty to destroy cancer cells instead of relying on more toxic and less specific drugs. Thus there are different and generally less toxic side effects than with standard chemotherapy. Rituxan is administered as an intravenous infusion (IV) once weekly for four weeks. You may have received chemotherapy or blood transfusions this same way in the past. Many patients receive a second four week course of Rituxan after a brief "rest" period. Rituxan had a complete or partial remission rate of 48% when tested in the early trials."
http://www.cancer-info.com/rituxan.htm

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Rituxan (Rituximab); Gene.com:"RITUXAN is indicated for the treatment of patients with relapsed or refractory, low-grade or follicular, CD20-positive, B-cell non-Hodgkin’s lymphoma. The RITUXAN® (Rituximab) antibody is a genetically engineered chimeric murine/human monoclonal antibody directed against the CD20 antigen found on the surface of normal and malignant B lymphocytes. The antibody is an IgG1 kappa immunoglobulin containing murine light- and heavy-chain variable region sequences and human constant region sequences. Rituximab is composed of two heavy chains of 451 amino acids and two light chains of 213 amino acids (based on cDNA analysis) and has an approximate molecular weight of 145 kD. Rituximab has a binding affinity for the CD20 antigen of approximately 8.0 nM."
http://www.gene.com/gene/products/information/oncology/rituxan/insert.jsp#indications

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Rituxan (Rituximab); idecpharm.com:"Rituxan® (Rituximab) is the first monoclonal antibody found to be effective and safe for the treatment of cancer in the United States. Rituxan is indicated for the treatment of patients with relapsed or refractory, low grade or follicular, CD20-positive, B-cell non-Hodgkin's lymphoma (NHL), which is cancer of the lymphatic system. It's a disease that's fatal in the large majority of patients. Rituxan is genetically engineered from portions of mouse and human antibodies and is produced through recombinant DNA technology."
http://www.idecpharm.com/site/science/rituxan.htm

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Rituxan (Rituximab); fda.gov/medwatch:"In seven of the eight fatalities, severe symptoms occurred during the first RITUXAN (rituximab) infusion. The cause of death was not reported or remains unknown for two of the eight cases. In most cases, death was preceded by severe bronchospasm, dyspnea, hypotension, and/or angioedema. Severe respiratory events, including hypoxia, pulmonary infiltrates, and adult respiratory distress syndrome, contributed to six of the eight reported deaths. In some cases symptoms worsened over time, while in others initial improvement was followed by clinical deterioration. Therefore, patients experiencing any of the severe infusion-related symptoms mentioned above or in the labeling (see ADVERSE REACTIONS section of the enclosed package insert) should be monitored closely until complete resolution of their symptoms occurs."
http://www.fda.gov/medwatch/safety/1998/rituxa.htm

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Rituxan (Rituximab); accessexcellence.org:"The approval by the FDA of the first antibody-based therapy for cancer represents good news for some patients with non-Hodgkin's lymphoma (NHL), as well as a milestone in biotech drug development. NHL occurs when B-cells, the cells that produce antibodies, begin to grow abnormally. The B-cells (or, more rarely, T-cells) divide too rapidly and grow out of control. Tumors result when too much tissue is formed. Because the lymphatic system is distributed throughout the body, the cancer cells may spread to other organs including the liver, spleen or the bone marrow. The new compound, called Rituxan or rituximab, is a genetically-engineered monoclonal antibody that targets a receptor called CD20 found on some B-cells. The Rituxan antibody marks the B-cells for destruction by the immune system, after which new B-cells are generated by stem cells. Stem-cells and B-cells bearing antibodies are spared by Rituxan, since they lack the CD20 antigen. Rituxan is a specific type of drug known as a chimeric monoclonal antibody. Chimeric antibodies take their name from the chimera, a mythical beast with the head of a lion, the body of a goat and the tail of a dragon. The Rituxan chimera is a hybrid of antibodies from both human and murine (mouse) sources. The CD20 antigen is injected into a mouse, encouraging the production of antibodies. Antibody producing cells are then isolated from the spleen of the animal. These are then combined with immortal cells called myeloma cells. This results in a cell line that will go on producing the antibody indefinitely. Further genetic engineering removes the elements of the mouse cell that would normally produce an immune (allergic) reaction if injected into a human."
http://www.accessexcellence.org/WN/SUA11/rituxan1197.html

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