Hypersensitivity Reactions, including Anaphylaxis: Serious hypersensitivity reactions, including some with fatal outcome, have been reported with the BEXXAR therapeutic regimen. Medications for the treatment of severe hypersensitivity reactions should be available for immediate use. Patients who develop severe hypersensitivity reactions should have infusions of the BEXXAR therapeutic regimen discontinued and receive medical attention (see WARNINGS).
Prolonged and Severe Cytopenias: The majority of patients who received the BEXXAR therapeutic regimen experienced severe thrombocytopenia and neutropenia. The BEXXAR therapeutic regimen should not be administered to patients with >25% lymphoma marrow involvement and/or impaired bone marrow reserve (see WARNINGS and ADVERSE REACTIONS).
Pregnancy Category X: The BEXXAR therapeutic regimen can cause fetal harm when administered to a pregnant woman.
Special requirements: The BEXXAR therapeutic regimen (Tositumomab and Iodine I 131 Tositumomab) contains a radioactive component and should be administered only by physicians and other health care professionals qualified by training in the safe use and handling of therapeutic radionuclides. The BEXXAR therapeutic regimen should be administered only by physicians who are in the process of being or have been certified by GlaxoSmithKline in dose calculation and administration of the BEXXAR therapeutic regimen.
The BEXXAR therapeutic regimen (Tositumomab and Iodine I 131 Tositumomab) is an anti-neoplastic radioimmunotherapeutic monoclonal antibody-based regimen composed of the monoclonal antibody, Tositumomab, and the radiolabeled monoclonal antibody, Iodine I 131 Tositumomab.
The BEXXAR therapeutic regimen (Tositumomab and Iodine I 131 Tositumomab) is indicated for the treatment of patients with CD20 antigen-expressing relapsed or refractory, low grade, follicular, or transformed non-Hodgkin's lymphoma, including patients with Rituximab-refractory non-Hodgkin’s lymphoma. Determination of the effectiveness of the BEXXAR therapeutic regimen is based on overall response rates in patients whose disease is refractory to chemotherapy alone or to chemotherapy and Rituximab. The effects of the BEXXAR therapeutic regimen on survival are not known.
The BEXXAR therapeutic regimen is not indicated for the initial treatment of patients with CD20 positive non-Hodgkin’s lymphoma. (See ADVERSE REACTIONS, Immunogenicity.)
The BEXXAR therapeutic regimen is intended as a single course of treatment. The safety of multiple courses of the BEXXAR therapeutic regimen, or combination of this regimen with other forms of irradiation or chemotherapy, has not been evaluated.
Media Articles Related to Bexxar (Tositumomab / Iodine I 131 Tositumomab)
Lifetime intense physical activity may lower risk for non-hodgkin lymphoma
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2015.05.01]
Performing vigorous physical activity over one's lifetime may lower risk for non-Hodgkin lymphoma (NHL).
Hodgkin lymphoma survivors have higher risk for cardiovascular diseases
Source: Cardiovascular / Cardiology News From Medical News Today [2015.04.28]
Survivors of Hodgkin lymphoma appear to be at higher risk for cardiovascular diseases and both physicians and patients need to be aware of this increased risk, according to an article published...
Hodgkin Lymphoma Survivors Need Long-Term Follow-Up for CVD (CME/CE)
Source: MedPage Today Oncology/Hematology [2015.04.28]
(MedPage Today) -- Risks highest for those treated before age 25 and with mediastinal radiotherapy or anthracyclines
Hodgkin's Lymphoma Survivors Face Higher Long-Term Heart Risks
Source: MedicineNet Hodgkins Disease Specialty [2015.04.28]
Title: Hodgkin's Lymphoma Survivors Face Higher Long-Term Heart Risks
Category: Health News
Created: 4/27/2015 12:00:00 AM
Last Editorial Review: 4/28/2015 12:00:00 AM
Higher CVD Risks Reported for Hodgkin's Lymphoma Survivors
Source: Medscape Hematology-Oncology Headlines [2015.04.27]
The longest follow-up to date of Hodgkin's lymphoma survivors has confirmed an increase in cardiovascular risks compared with the general population.
Medscape Medical News
Published Studies Related to Bexxar (Tositumomab / Iodine I 131 Tositumomab)
Tositumomab and iodine-131 tositumomab produces durable complete remissions in a subset of heavily pretreated patients with low-grade and transformed non-Hodgkin's lymphomas. [2005.10.20]
PURPOSE: This study is an integrated efficacy analysis of the five clinical trials of tositumomab and iodine-131 tositumomab in patients with relapsed or refractory low-grade, follicular, or transformed low-grade non-Hodgkin's lymphoma (NHL) that resulted in the regulatory approval of the iodine-131 tositumomab by the US Food and Drug Administration... CONCLUSION: The tositumomab and iodine-131 tositumomab therapeutic regimen produces high response rates in patients with relapsed or refractory low-grade, follicular, and transformed low-grade NHL, with a sizable subgroup of patients achieving long-term durable responses.
Phase III randomized study of rituximab/carmustine, etoposide, cytarabine, and
melphalan (BEAM) compared with iodine-131 tositumomab/BEAM with autologous
hematopoietic cell transplantation for relapsed diffuse large B-cell lymphoma:
results from the BMT CTN 0401 trial. 
relapsed diffuse large B-cell lymphoma (DLBCL)... CONCLUSION: The B-BEAM and R-BEAM regimens produced similar 2-year PFS and OS
Phase III randomized intergroup trial of CHOP plus rituximab compared with CHOP
chemotherapy plus (131)iodine-tositumomab for previously untreated follicular
non-Hodgkin lymphoma: SWOG S0016. 
15, 2008... CONCLUSION: There was no evidence of a significant improvement in PFS comparing
Six of 12 relapsed or refractory indolent lymphoma patients treated 10 years ago with 131I-tositumomab remain in complete remission. [2011.06]
The purpose of our study was to update the safety and efficacy results of radioimmunotherapy in relapsed or resistant indolent or transformed non-Hodgkin lymphoma... CONCLUSION: Optimal patient benefit might be obtained in indolent lymphoma when administering radioimmunotherapy up-front in combination with chemotherapy and rituximab treatment. However, these results show that radioimmunotherapy alone achieved long-lasting remissions in 6 of 12 (50%) indolent lymphoma patients in relapse after 1 or multiple chemotherapies.
Tositumomab and iodine I 131 tositumomab (Bexaar). [2011.04]
Tositumomab and iodine I 131 tositumomab (Bexaar) therapeutic regimen targets monoclonal antibodies against the CD20 antigen expressed in non-Hodgkin lymphoma. This article reviews the mechanism of action and clinical indications for this regimen..
Clinical Trials Related to Bexxar (Tositumomab / Iodine I 131 Tositumomab)
Clinical Trial of Consolidation Treatment With Iodine I 131 Tositumomab for Multiple Myeloma [Recruiting]
This study is for patients with newly diagnosed or relapsed multiple myeloma. The main
purpose of this study is to see how their disease responds to consolidation treatment
(treatment aimed at further decreasing cancer cells) with a radioactive antibody (protein)
called iodine I 131 tositumomab (known by the tradename Bexxar®) and also to look at the
side effects which occur with this type of treatment. The investigators will also be
looking at how long disease responds to treatment, if it responds at all, and how long
patients who have had this treatment survive.
Bexxar is a monoclonal antibody (protein) to which radioactive iodine 131 is attached. The
monoclonal antibody in Bexxar (tositumomab), targets a protein called CD20 found on the
surface of a variety of B-cells, including lymphoma cells, and some myeloma cells. The
antibody is given as an infusion and finds its way to these cells. The radioactive iodine
attached to the antibody delivers radiation directly to these cells which works to harm or
kill the cancer cells. Approximately 20-25% of patients with multiple myeloma have this
protein on the surface of their tumor cells. In addition, this protein was found on the
surface of myeloma stem cells. While myeloma stem cells represent a minority of all myeloma
cells (less than 5%), these cells are resistant to chemotherapy and are believed to be
responsible for a recurrence of the disease after chemotherapy. In this study, Bexxar will
be used after patients complete a course of chemotherapy and have residual myeloma cells
left in their body. The Investigators are hoping that the treatment with Bexxar will
decrease and possibly eliminate residual myeloma cells resistant to chemotherapy.
Tositumomab and Iodine I 131 Tositumomab in Treating Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma in First Remission [Recruiting]
This phase II trial studies how well tositumomab and iodine I 131 tositumomab works in
treating patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma
(SLL) in first remission. Monoclonal antibodies, such as tositumomab and iodine I 131
tositumomab, can block cancer growth in different ways. Some block the ability of cancer to
grow and spread. Others find cancer cells and help kill them or carry cancer cancer-killing
substances to them
Iodine I 131 Tositumomab and Fludarabine Phosphate in Treating Older Patients Who Are Undergoing an Autologous or Syngeneic Stem Cell Transplant for Relapsed or Refractory Non-Hodgkin's Lymphoma [Recruiting]
RATIONALE: Radiolabeled monoclonal antibodies, such as iodine I 131 tositumomab, can find
cancer cells and carry cancer-killing substances to them without harming normal cells. Drugs
used in chemotherapy, such as fludarabine phosphate, work in different ways to stop the
growth of cancer cells, either by killing the cells or by stopping them from dividing. A
peripheral stem cell transplant may be able to replace blood-forming cells that were
destroyed by chemotherapy and radiation therapy. Giving iodine I 131 tositumomab together
with fludarabine phosphate followed by autologous stem cell transplant may be an effective
treatment for non-Hodgkin's lymphoma.
PURPOSE: This phase I trial is studying the side effects and best dose of fludarabine when
given together with iodine I 131 tositumomab in treating older patients who are undergoing
an autologous or syngeneic stem cell transplant for relapsed or refractory B-cell
Trial of Low-Dose MTX and I 131 Tositumomab for Previously Untreated, Advanced-Stage, Follicular Lymphoma [Recruiting]
Patients with a type of non-Hodgkin lymphoma, called follicular lymphoma and have not yet
had previous systemic treatment, such as chemotherapy or immunotherapy will be invited to
participate. This research study is being conducted in order to evaluate the combination of
lowdose methotrexate and 131I-tositumomab (Bexxar) with regards to whether the combination
will reduce the occurrence of the HAMA (Human Anti-Mouse Antibody) response. HAMA is an
immune reaction against the tositumomab protein. Symptoms arising from HAMA can range from a
mild form, like a rash, to a more extreme and possibly life-threatening level. HAMA can also
decrease the effectiveness of the treatment, or create a future reaction if a patient is
given another treatment containing mouse antibodies. In addition to evaluating the
occurrence of HAMA, this research study will also look at the short and long-term
effectiveness of this combination in the treatment of lymphoma, as well as its safety.
A Comparison Of Rituximab vs. Iodine I 131 Tositumomab Therapeutic Regimen (i.e., BEXXAR) For Patients With Relapsed Follicular Non-Hodgkins Lymphoma [Active, not recruiting]
Comparison of rituximab versus Iodine I 131 Tositumomab therapeutic regimen in subjects with follicular non Hodgkins B cell lymphoma. 506 subjects will be enrolled at 30 to 40 sites in the US, Canada, and Europe. Subjects will be randomly assigned to one of two treatment arms. In Arm A, subjects will receive 375 milligrams/meter2 (mg/m2 )of rituximab, given as an intravenous (IV) infusion once weekly for 4 weeks. In Arm B, subjects will undergo a two-phase treatment. In the first phase, termed the 'dosimetric dose', subjects will receive an infusion of unlabeled Tositumomab (450 mg) immediately followed by an infusion of 5 millicuries (mCi) (0. 18 gigabecquerel [GBq]) of Iodine 131 Tositumomab (35 mg). Whole body gamma camera scans will be obtained three times (Day 0; Day 2, 3, or 4; and Day 6 or 7) following the dosimetric dose. The information derived from the scans will enable a patient specific dose to be calculated to deliver the desired total body dose of radiation (65 or 75 centigray [cGy]). In the second phase, termed the 'therapeutic dose', subjects in Arm B will receive an infusion of unlabeled Tositumomab (450 mg) immediately followed by an infusion of the subject specific activity of Iodine 131-conjugated Tositumomab (35 mg). Thyroid blockade will be implemented 24 hours prior to the dosimetric dose and continued for 14 days following the therapeutic dose. Subjects on study will be followed for response and safety at Week 7, Week 13, and every three months for the first and second year, every six months for the third year, and then annually for the forth and fifth years; and then for vital status, additional therapy, and long term safety events through year ten. Follow Up after subsequent NHL therapy will be carried out to assess tolerance of next anti-lymphoma therapy, development of myelodysplasia (MDS)/acute myelogenous leukemia (AML), HAMA or hypothyroidism, unexpected safety issues, and death.
Page last updated: 2015-05-01