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Rituxan (Rituximab) - Summary



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.)

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.)

Severe Mucocutaneous Reactions:    Severe mucocutaneous reactions, some with fatal outcome, have been reported in association with RITUXAN treatment. (See WARNINGS and ADVERSE REACTIONS.)



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.

RITUXAN® (Rituximab) is indicated for the treatment of patients with relapsed or refractory, low-grade or follicular, CD20-positive, B-cell non-Hodgkin's lymphoma.

See all Rituxan indications & dosage >>


Media Articles Related to Rituxan (Rituximab)

Global long-term study: Rituxan shows consistent safety profile over 11 years
Source: Arthritis / Rheumatology News From Medical News Today [2015.08.20]
The online edition of The Journal of Rheumatology has published a study on the long-term safety of Rituxan which found that it has a consistent safety profile over time and through multiple courses...

Non-Hodgkin's Lymphoma
Source: MedicineNet Biological Therapy Specialty [2015.04.01]
Title: Non-Hodgkin's Lymphoma
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 4/1/2015 12:00:00 AM

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Published Studies Related to Rituxan (Rituximab)

Idelalisib and rituximab in relapsed chronic lymphocytic leukemia. [2014]
are needed for this patient population... CONCLUSIONS: The combination of idelalisib and rituximab, as compared with

Rituximab for childhood-onset, complicated, frequently relapsing nephrotic syndrome or steroid-dependent nephrotic syndrome: a multicentre, double-blind, randomised, placebo-controlled trial. [2014]
in patients with high disease activity... INTERPRETATION: Rituximab is an effective and safe treatment for childhood-onset,

Pharmacological treatment for memory disorder in multiple sclerosis. [2013]
CONCLUSIONS: We found no convincing evidence to support the efficacy of

Reactivation of latent viruses in individuals receiving rituximab for new onset type 1 diabetes. [2013]
in the phase-2 rituximab study... CONCLUSIONS: Four doses of rituximab administered to individuals with early onset

Treatment of antineutrophil cytoplasmic antibody-associated vasculitis with rituximab. [2012.01]
PURPOSE OF REVIEW: To review the present knowledge about the use of rituximab (RTX) in patients with granulomatosis with polyangiitis (Wegener's; GPA), microscopic polyangiitis (MPA), and eosinophilic granulomatosis with polyangiitis (Churg-Strauss; EGPA), also collectively referred to as antineutrophil cytoplasmic antibody-associated vasculitis...

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Clinical Trials Related to Rituxan (Rituximab)

Fludarabine, Mitoxantrone, and Dexamethasone (FND) Plus Rituximab for Lymphoma Patients [Active, not recruiting]
Primary Objectives:

1. To compare molecular response rates with the FND regimen followed by rituximab (chimeric anti-CD20 antibody) and interferon versus FND plus rituximab concurrently, followed by interferon, for patients with stage IV indolent lymphoma.

2. To compare the toxicity of these two regimens, including their effects on B- and T-cell subsets, immunoglobulins, and patterns of infections.

3. To compare failure-free and overall survival rates with these two regimens.

4. To identify and treat with a separate strategy those follicular lymphoma patients without bcl-2 mbr or mcr gene rearrangement ("germline" patients) because of their adverse outcome with FND alone in our prior experience.

Study of Dynavax's 1018 ISS, Following Rituxan in Patients With B-Cell Follicular Lymphoma [Active, not recruiting]
The main purpose of this study is to determine the effects (good and bad) and the safety of Dynavax's immunostimulatory phosphorothiolate oligodeoxyribonucleotide (1018 ISS) given in combination with Rituxan on patients with B-cell follicular non-Hodgkin's lymphoma. This research is being done because recurrent follicular non-Hodgkin's lymphoma is not curable with standard chemotherapy or antibody treatments. 1018 ISS is an experimental compound that consists of short pieces of DNA that stimulate the immune system. It is hoped that 1018 ISS may improve the ability of Rituxan to kill cancer cells.

Treatment of Relapsed Low-Grade or Follicular Lymphoma With Rituximab (Also Known as Rituxan, IDEC-C2B8, IDEC-102) [Completed]
Rituximab is an antibody made in a laboratory. It binds to lymphoma cells and kills them. Treatment of recurrent B-cell lymphoma with rituximab may delay or prevent relapses. A total of 166 patients with recurrent B-cell lymphoma were given intravenous rituximab once a week for 4 weeks. The patients' tumors were measured before and after treatment. Ten patients had a complete response and 70 patients had a partial response to rituximab. The median duration of response was 11. 2 months.

Rituximab (Rituxan) for the Prevention of EBV-LPD Epstein Barr Virus (EBV) Lymphoproliferative Disorder Post T Cell Depleted Unrelated and HLA Mis-Matched Related HSCT [Active, not recruiting]
The purpose of this study is to determine if we can prevent Epstein Barr Virus lymphomas by the monthly administration of an (antibody) protein against B lymphocytes called Rituximab. Although this medicine has been approved by the Food and Drug Administration to treat patients with other types of lymphomas, and has been used to treat a small number of patients with EBV lymphomas and other types of B-cell leukemias, it has not been approved to try and prevent EBV-lymphomas. Use of Rituximab to try to prevent EBV-lymphomas is therefore experimental.

Safety Study of Rituximab (RituxanŽ) in Chronic Urticaria [Suspended]
This study is being done to find out if a drug called Rituxan (Rituximab) is safe and effective in treating people with chronic urticaria (hives) with persistent symptoms in spite of taking antihistamines.

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Reports of Suspected Rituxan (Rituximab) Side Effects

Death (115)Dyspnoea (37)Pyrexia (22)Pneumonia (22)Progressive Multifocal Leukoencephalopathy (20)Fatigue (18)Vomiting (18)Nausea (17)Diarrhoea (17)Rash (16)more >>

Page last updated: 2015-08-20

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