Links
Sources of Additional Non-Hodgkin's Lymphoma (NHL) and RITUXAN® (Rituximab) Information
This section provides links to relevant Web sites that will help you expand your knowledge about NHL and gain access to additional information that you may find useful in your practice.
Genentech, Inc. and Biogen Idec are neither affiliated with nor endorse any of the following organizations.
Associations and Societies
Below is a list of professional organizations committed to research, development, and education in the diagnosis and treatment of solid-tumor cancers and/or hematological neoplasms.
American Association for Cancer Research (AACR)
The American Association for Cancer Research is a professional organization of more than 27,000 cancer researchers. The AACR is the oldest and largest scientific organization in the world focused on every aspect of high-quality, innovative cancer research.
American Medical Association (AMA)
The nation's leader in promoting professionalism in medicine, setting standards for medical education and ethics, and advancing the betterment of public health.
American Society for Therapeutic Radiology and Oncology (ASTRO)
An organization of physicians and scientists committed to the advancement of radiation oncology, promoting excellence in patient care, and providing opportunities for educational and professional development.
American Society of Clinical Oncology (ASCO)
A non-profit organization that supports various types of cancer research, in particular, patient-oriented clinical research.
American Society of Hematology (ASH)
A society of clinicians and scientists committed to charitable, scientific, and educational activities that promote the exchange of information and ideas relating to blood, blood-forming tissues, and blood diseases.
The Leukemia & Lymphoma Society (LLS)
The nation's largest voluntary health organization committed to improving the quality of life of patients and their families, and funding research grants to find cures for leukemia, lymphoma, Hodgkin's disease, and myeloma.
Lymphoma Research Foundation of America (LRF)
A nationally recognized organization committed to funding lymphoma research grants and providing education and support to patients and their families.
National Cancer Institute (NCI)
Sponsored by the US government, this organization leads the nation's fight against cancer by supporting cancer research and promoting treatment, prevention, and quality of care for patients and their families.
National Comprehensive Cancer Network (NCCN®)
A non-profit tax-exempt corporation that is an alliance of the world's leading cancer centers. The NCCN is committed to the enhancement and delivery of quality cancer care to patients, and advancing cancer prevention, screening, diagnosis, and treatment.
Medical Databases
Below is a list of databases that allow you to search medical journals, clinical trial protocols, national meeting abstracts, and other resources that include relevant information.
DIRLINE (Directory of Information Resources Online): Directory of Health Organizations
The National Library of Medicine's online database, which contains detailed information about a variety of health-related resources, including organizations, research materials, projects, and databases pertaining to health and biomedicine.
Medline/PubMed
A service of the National Library of Medicine that provides access to over 11 million citations from MEDLINE and additional life science journals, and includes links to additional sites that provide full-text articles and other related resources.
MedlinePlus® Health Information
A service of the National Library of Medicine that provides access to extensive information about specific diseases and conditions, and includes links to dictionaries, clinical trials, lists of hospitals and physicians, and consumer health information from the National Institutes of Health.
National Library of Medicine Locator Plus
The National Library of Medicine's catalog of books, journals, audiovisuals, medical research tools, and various health-related resources.
INDICATIONS AND USAGE
Rituxan® (rituximab) is indicated for the treatment of patients with:
- Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent
- Previously untreated follicular, CD20-positive, B-cell NHL in combination with CVP chemotherapy
- Non-progressing (including stable disease), low-grade, CD20-positive B-cell NHL, as a single agent, after first-line CVP chemotherapy
- Previously untreated diffuse large B-cell, CD20-positive NHL in combination with CHOP or other anthracycline-based chemotherapy regimens
BOXED WARNINGS and Additional Important Safety Information
WARNING: FATAL INFUSION REACTIONS, TUMOR LYSIS SYNDROME (TLS), SEVERE MUCOCUTANEOUS REACTIONS, and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML)
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. Carefully monitor patients during infusions. Discontinue Rituxan infusion and provide medical treatment for Grade 3 or 4 infusion reactions.
Tumor Lysis Syndrome (TLS)
Acute renal failure requiring dialysis with instances of fatal outcome can occur in the setting of TLS following treatment of non-Hodgkin's lymphoma (NHL) patients with Rituxan.
Severe Mucocutaneous Reactions
Severe, including fatal, mucocutaneous reactions can occur in patients receiving Rituxan.
Progressive Multifocal Leukoencephalopathy (PML)
JC virus infection resulting in PML and death can occur in patients receiving Rituxan.
Rituxan has also been associated with fatal hepatitis B reactivation with fulminant hepatitis, other serious viral infections, cardiovascular events, renal toxicity, and bowel obstruction and perforation.
The most common adverse reactions of Rituxan (incidence ≥25%) observed in patients with NHL are infusion reactions, fever, chills, infection, asthenia, and lymphopenia. The incidence of infusion reactions was highest during the first infusion (77%) and decreased with each subsequent infusion. These infusion reactions generally have resolved with slowing or interruption of the infusion and with supportive care.
Indication-Specific Safety
Single Agent Rituxan for Relapsed or Refractory, Low-Grade or Follicular NHL
The most common adverse reactions of Rituxan (incidence ≥ 25%) observed in patients with relapsed or refractory, low-grade or follicular NHL are infusion reactions, fever, chills, infection, asthenia, and lymphopenia. Respiratory system events were reported in 38% of patients, and 31% reported infectious events. Grade 3 and 4 cytopenias were reported in 48% of patients and included lymphopenia (40%), neutropenia (6%), leukopenia (4%), anemia (3%), and thrombocytopenia (2%).
Rituxan in Combination with CVP for Previously Untreated, Follicular NHL
Patients in the R-CVP arm had higher incidences of infusional toxicity and of neutropenia as compared to those in the CVP arm. The following adverse reactions occurred more frequently (≥5%) in patients receiving R-CVP compared to CVP alone: rash (17% vs 5%), cough (15% vs 6%), flushing (14% vs 3%), rigors (10% vs 2%), pruritus (10% vs 1%), neutropenia (8% vs 3%), and chest tightness (7% vs 1%).
Single Agent Rituxan for Low-Grade NHL, after First-Line CVP Chemotherapy
The following common adverse reactions were reported more frequently (≥5%) in patients receiving Rituxan following CVP compared with those who received no further therapy: fatigue (39% vs 14%), anemia (35% vs 20%), peripheral sensory neuropathy (30% vs 18%), infections (19% vs 9%), pulmonary toxicity (18% vs 10%), hepatobiliary toxicity (17% vs 7%), rash and/or pruritus (17% vs 5%), arthralgia (12% vs 3%), and weight gain (11% vs 4%). Neutropenia was the only Grade 3 or 4 adverse reaction that occurred more frequently (≥2%) in the Rituxan arm compared with those who received no further therapy (4% vs 1%).
Rituxan in Combination with CHOP Chemotherapy for DLBCL
The following adverse reactions, regardless of severity, were reported more frequently (≥5%) in patients age ≥60 years receiving R-CHOP as compared to CHOP alone: pyrexia (56% vs 46%), lung disorder (31% vs 24%), cardiac disorder (29% vs 21%), and chills (13% vs 4%). In the GELA LNH 98-5 study, a review of cardiac toxicity determined that supraventricular arrhythmias or tachycardia accounted for most of the difference in cardiac disorders (4.5% for R-CHOP vs. 1.0% for CHOP).
The following Grade 3 or 4 adverse reactions occurred more frequently among patients in the R-CHOP arm compared with those in the CHOP arm: thrombocytopenia (9% vs 7%) and lung disorder (6% vs 3%). Other Grade 3 or 4 adverse reactions reported more frequently among patients receiving R-CHOP were viral infection (GELA LNH 98-5 study), neutropenia (GELA LNH 98-5 and MInT studies), and anemia (MInT study).
For additional safety information, please see the full prescribing information, including BOXED WARNINGS and Medication Guide.
Attention Healthcare Provider: Provide Medication Guide to patient prior to Rituxan infusions.
