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Rituxan (Rituximab) - Summary

 
 



BOX 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.)

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.)

 

RITUXAN SUMMARY

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 >>

NEWS HIGHLIGHTS

Media Articles Related to Rituxan (Rituximab)

RheumShorts: MRI in RA, Fostamatinib, Statins and Rituximab (CME/CE)
Source: MedPage Today Radiology [2014.07.30]
(MedPage Today) -- Studies this week in Annals of the Rheumatic Diseases highlighted the potential role for MRI in predicting progression in early rheumatoid arthritis (RA), negative results with fostamatinib, and the use of statins among patients taking rituximab (Rituxan).

Non-Hodgkin's Lymphoma
Source: MedicineNet Biological Therapy Specialty [2014.03.14]
Title: Non-Hodgkin's Lymphoma
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 3/14/2014 12:00:00 AM

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Published Studies Related to Rituxan (Rituximab)

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...

Use of intravenous immunoglobulin to treat chronic bilateral otomastoiditis in the setting of rituximab induced hypogammaglobulinemia. [2012]
The temporal bone may be affected by a variety of systemic pathology because the disease nature, location, and extent determine the symptoms... Here, we describe the first presentation, diagnostic workup, and treatment with intravenous immunoglobulin of chronic bilateral otomastoiditis in the setting of rituximab-induced hypogammaglobulinemia.

Efficacy and safety of rituximab in patients with active proliferative lupus nephritis: the Lupus Nephritis Assessment with Rituximab study. [2012]
treated concomitantly with mycophenolate mofetil (MMF) and corticosteroids... CONCLUSION: Although rituximab therapy led to more responders and greater

A randomized, controlled, trial of rituximab for treatment of severe cryoglobulinemic vasculitis. [2011.12.06]
OBJECTIVE: A prospective, long-term randomized controlled trial was designed to support the use of rituximab (RTX) for severe mixed cryoglobulinemia or cryoglobulinemic vasculitis (CV)... CONCLUSION: RTX monotherapy represents a very good option for severe CV and may be maintained in the long term in most patients. Copyright (c) 2011 by the American College of Rheumatology.

A randomized controlled trial of rituximab following failure of antiviral therapy for hepatitis C-associated cryoglobulinemic vasculitis. [2011.12.06]
OBJECTIVES: To report on the results of a randomized controlled trial of rituximab in hepatitis C virus (HCV)-associated mixed cryoglobulinemic vasculitis... CONCLUSIONS: Therapy with rituximab was well tolerated and effective treatment for patients with HCV-associated cryoglobulinemic vasculitis in whom antiviral therapy fails to induce remission. Copyright (c) 2011 by the American College of Rheumatology.

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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: 2014-07-30

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