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.)
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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.
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NEWS HIGHLIGHTSMedia Articles Related to Rituxan (Rituximab)
Non-Hodgkin's Lymphoma
Source: MedicineNet Biological Therapy Specialty [2017.03.03]
Title: Non-Hodgkin's Lymphoma
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 3/3/2017 12:00:00 AM
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...
Clinical Trials Related to Rituxan (Rituximab)
A Pilot Trial of Rituxan in Refractory Myasthenia Gravis [Completed]
Myasthenia gravis is a disease that happens because the immune system attacks the nervous
system. The damage is caused by antibodies produced by B lymphocytes. These antibodies
damage a special part of the muscle that helps transmit impulses from nerves to muscles to
allow muscles to work properly. This damage results in symptoms of myasthenia gravis.
Participants are being asked to participate in this research study because their myasthenia
gravis has either failed to respond to treatments commonly used in the disease, or they have
had bad side-effects from such treatments.
This is a research study of a drug called Rituximab. Rituximab, also called Rituxan, is a
mouse antibody that has been changed to make it similar to a human antibody. Antibodies are
proteins that can protect the body from foreign invaders, such as bacteria and viruses, by
binding to substances called antigens. Rituxan works by binding to a protein, called the
CD20 protein. Rituxan helps to destroy white blood cells that produce antibodies in the
body, called B-lymphocytes. It is a treatment given through a vein in the participant's arm
over a period of approximately 4-6 hours. It has been approved by the Food and Drug
Administration (FDA) for use in patients with a form of cancer of the lymph glands called
Non-Hodgkin's Lymphoma (NHL). Rituximab is not approved for their myasthenia gravis.
Treatment with Rituximab is being tried in this research study because Rituximab decreases B
lymphocytes. There is preliminary evidence that Rituximab helps some patients with chronic
and otherwise difficult to treat myasthenia gravis.
Rituximab to Treat Moderate Aplastic Anemia, Pure Red Cell Aplasia, or Diamond Blackfan Anemia [Completed]
This study will test whether the immune-suppressing drug rituximab can increase blood counts
and reduce the need for transfusions in patients with moderate aplastic anemia, pure red
cell aplasia, or Diamond Blackfan anemia. These are rare and serious blood disorders in
which the immune system turns against bone marrow cells, causing the bone marrow to stop
producing red blood cells in patients with pure red cell aplasia and Diamond Blackfan
anemia, and red blood cells, white blood cells and platelets in patients with aplastic
anemia. Rituximab is a laboratory-made monoclonal antibody that recognizes and destroys
white blood cells called lymphocytes that are responsible for destroying bone marrow cells
in these diseases. The drug is currently approved by the Food and Drug Administration for
treating patients with B-cell non-Hodgkin lymphoma, a disease of white blood cells.
Combination Therapy Using Lenalidomide (Revlimid)- Low Dose Dexamethasone and Rituximab for Treatment of Rituximab-Resistant, Non-Aggressive B-Cell Lymphomas [Active, not recruiting]
Pre-clinical data and recently published clinical data suggest a synergistic effect between
lenalidomide and dexamethasone. We hypothesize that a combination of
lenalidomide-dexamethasone can overcome rituximab resistance. To determine the response rate
to lenalidomide and dexamethasone plus rituximab therapy in subjects with recurrent small
B-cell non-Hodgkin lymphoma who have had lymphoma progression within 6 months of being
treated with rituximab alone or with a rituximab-containing regimen, we propose initial
treatment with both drugs for two 28-day treatment cycles (Part I). After response
assessment following two cycles of lenalidomide-dexamethasone, patients will enter Part II
of the study. In Part II, patients will receive lenalidomide-dexamethasone and rituximab to
evaluate the potential reversal of rituximab resistance as measured by response to rituximab
and progression-free survival following rituximab.
Rituximab to Treat Stiff Person Syndrome [Completed]
This study will test whether rituximab (RITUXAN (Trademark)) can relieve symptoms of stiff
person syndrome (SPS), a progressive disease that causes stiffness of the muscles and muscle
spasms induced by unexpected noises, touches, or stressful events. People with SPS may have
certain proteins in their blood called anti-GAD antibodies that may cause some of the
symptoms of the disease. Rituximab, a drug approved to treat lymphomas, targets certain
white blood cells that produce antibodies. This study will see if rituximab can also be
effective in patients with SPS who have high anti-GAD antibodies.
Patients between 25 and 80 years of age with SPS may be eligible for this study. Candidates
are screened with a medical history, physical examination, and blood tests. Participants
undergo the following tests and procedures:
- Rituximab or placebo treatment: Patients are randomly assigned to receive two infusions
by vein of either rituximab or placebo (a look-alike solution with no active
ingredient) 2 weeks apart. The infusions last from 3 to 4 hours, but may take as long
as 16 hours if the rate must be slowed for any reason. Patients are followed monthly
for up to 6 months and then every 2 months for up to 1 year after treatment.
- Medical history and interview, physical and neurological examinations: Patients are
questioned about their vaccination history, medical, surgical, and psychiatric history,
exposure to environmental toxins or viruses, and family and social history, including
habits and employment.
- Blood drawing: Blood samples are collected before the two infusions and at all
follow-up visits.
- Apheresis: For this procedure, which is used to collect white blood cells, blood is
collected through a needle in an arm vein, similar to donating blood. The blood flows
from the vein through a catheter (plastic tube) into a machine that separates it into
its components by centrifugation (spinning). The white cells are removed and the rest
of the blood (red cells, plasma and platelets) is returned to the body through a second
needle in the other arm. The procedure takes about 60 to 90 minutes.
- Lumbar puncture (spinal tap): Lumbar puncture is done to sample a small amount of
cerebrospinal fluid (CSF, the fluid that bathes the brain and spinal cord), for
analysis. For this procedure, the patient is given a local anesthetic and a needle is
inserted into the space between the bones in the lower back where the CSF circulates
below the spinal cord. A small amount of fluid is withdrawn through the needle.
Rituximab for GVHD [Withdrawn]
This is a prospective, open-label pilot study in which 4 doses of Rituximab are administered
to patients who have developed SR-aGVHD following allogeneic hematopoietic transplant (AHT).
The study is designed to determine the overall survival at 180 days after treatment with
rituximab, and evaluates the safety and clinical response to rituximab in this study
population. Study entry: Patients must enter study on or before day +100 posttransplant.
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 >>
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Page last updated: 2017-03-03
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