BEXXAR therapeutic regimen for non-Hodgkin's lymphoma

The BEXXAR therapeutic regimen (Tositumomab and Iodine I 131 Tositumomab) may be useful for patients whose disease has not responded to prior therapy or has returned after therapy and who have CD20-positive, low-grade, follicular non-Hodgkin's lymphoma or follicular non-Hodgkin's lymphoma that has transformed to a faster-growing form. BEXXAR is approved by the FDA for patients who have already received chemotherapy or a drug called Rituxan^Ž (Rituximab),² or a combination of both. Your doctor can tell you if BEXXAR is right for you. It is not known if BEXXAR will help patients live longer. BEXXAR is not for patients who have never received treatment for their non-Hodgkin’s lymphoma. BEXXAR is given to patients only once. It is not known if BEXXAR is safe to give to patients more than once, or to give together with other types of therapy, like chemotherapy or radiation treatments.

Follow the links below to learn more about the BEXXAR therapeutic regimen for non-Hodgkin's lymphoma:

BEXXAR: Product Information Patient Support

WARNINGS ¹

Treatment with BEXXAR does involve risk.

Serious Allergic Reaction: Patients may develop serious allergic reactions with the intravenous (IV) infusion of BEXXAR. In some cases, death has been reported. Medications for the treatment of severe reactions should be available for immediate use by a physician. Patients who develop severe reactions should have the infusion of BEXXAR stopped and receive appropriate medical attention.

Low Blood Counts: Most patients who received BEXXAR developed prolonged and severe low blood counts. This can lead to serious infections or bleeding problems.

Not for Pregnant Women: BEXXAR can harm a fetus when given to a pregnant woman.

Special Requirements: BEXXAR contains radioactive material and should be administered only by physicians and other healthcare workers who are qualified by training in the safe use and handling of radioactive materials.

IMPORTANT SAFETY INFORMATION¹

Not for Everyone: Not all patients are candidates for treatment with BEXXAR. Patients with a known prior reaction to a mouse protein, or any other part of BEXXAR, should not be given BEXXAR. Patients with more than one quarter of their bone marrow space occupied by lymphoma cells, patients with a low bone marrow reserve, or women who are pregnant should also not be treated with BEXXAR.

Low Blood Counts: The most common early side effects were very low blood counts in 71% of the patients. The lowest counts usually occurred around 4-7 weeks after the first dose of BEXXAR and lasted about a month. Your doctor should check your blood (a CBC) weekly, or more often, until your counts recover. Because of low counts your doctor might also ask you to take some precautions against infection or bleeding. Infections occurred in approximately half of the patients (serious infections in 9% of 230). Bleeding occurred in 12% of patients. Most of these cases were mild to moderate. About one quarter of the patients required drugs or blood transfusions during this period to help their counts recover.

Development of Allergy: In 10% to 11% of patients, administration of BEXXAR resulted in development of antibodies to the mouse protein in BEXXAR, which their bodies considered to be a foreign protein. These antibodies go by the name HAMA (human anti-mouse antibody). If a person makes HAMA, they could have a serious allergic reaction to any other drug or diagnostic test that was made from mouse protein or it could affect how well the drug or diagnostic test worked.

Development of Other Cancer: Ten percent of patients (98 of 995) developed a second cancer: 44 patients had preleukemia and/or leukemia and 54 patients had other cancers (65 cases). Approximately half of these were skin cancers and the others, in decreasing frequency, which occurred in 2 or more patients, included colorectal cancer, head and neck cancer, breast cancer, lung cancer, bladder cancer, melanoma, and gastric cancer. Whether there is an increased risk of developing another cancer after BEXXAR is difficult to determine since a group of similar patients who did not receive BEXXAR was not evaluated.

Thyroid Problems: In 13% to 18% of patients, treatment with BEXXAR resulted in hypothyroidism (lowered production of thyroid hormone or receiving thyroid replacement therapy). All patients are given medication prior to and during treatment with BEXXAR to attempt to block the uptake of the radioactive iodine part of BEXXAR by the thyroid gland. Patients who cannot tolerate this medication should not be given BEXXAR. After treatment, patients should be seen by their physicians yearly for signs and symptoms of hypothyroidism and screened with a blood test. Hypothyroidism is treated by taking a daily pill to replace thyroid hormone.

Problems with Infusion: Side effects experienced during or following the infusion of BEXXAR include fever, chills, sweating, nausea, low blood pressure, shortness of breath, and wheezing. Twenty-nine percent of patients reported fever, chills, or sweating following the first dose. Most side effects were managed by slowing or stopping the related infusion for a time. In 2 patients, the infusion had to be stopped and the patients did not receive all of the drug.

Distribution of BEXXAR: After infusion of the dosimetric dose, the distribution of BEXXAR in your body will be reviewed using 3 scans over 7 days, and if the distribution is not normal, your doctor may decide not to administer the therapeutic dose.

Other: BEXXAR may result in other side effects. Please see the Prescribing Information (PI) for more information about the Warnings, Contraindications, and Adverse Events for BEXXAR.

Complete Prescribing Information for
BEXXAR (Tositumomab and Iodine I 131 Tositumomab)

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