Bexxar

Bexxar

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Uses

1.1 Relapsed or Refractory CD20-Positive, Non-Hodgkin’s Lymphoma

The BEXXAR® therapeutic regimen (tositumomab and iodine I 131 tositumomab) is indicated for the treatment of patients with CD20-positive relapsed or refractory, low grade, follicular, or transformed non-Hodgkin's lymphoma who have progressed during or after rituximab therapy, 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 and rituximab. The effects of the BEXXAR therapeutic regimen on survival are not known.

1.2 Important Limitations of Use
The BEXXAR therapeutic regimen is only indicated for a single course of treatment.
The safety and efficacy of additional courses of the BEXXAR therapeutic regimen have not been established.
The BEXXAR therapeutic regimen is not indicated for first-line treatment of patients with CD20-positive non-Hodgkin's lymphoma.

History

There is currently no drug history available for this drug.

Other Information

The BEXXAR therapeutic regimen is composed of the monoclonal antibody tositumomab, and the radiolabeled monoclonal antibody, I-131 tositumomab.

Tositumomab is a murine IgG2a lambda monoclonal antibody directed against the CD20 antigen, produced in mammalian cells. The approximate molecular weight of tositumomab is 150 kD.

Tositumomab is supplied as a sterile, pyrogen-free, clear to opalescent, colorless to slightly yellow, preservative-free solution that must be diluted before intravenous administration. The formulation contains 100 mg/mL maltose, 8.5 mg/mL sodium chloride, 1 mg/mL phosphate, 1 mg/mL potassium hydroxide, and Water for Injection, USP. The pH is approximately 7.2.

I-131 tositumomab is tositumomab covalently linked to Iodine-131. I-131 tositumomab is supplied as a sterile, clear, preservative-free liquid. The formulation for I-131 tositumomab contains 0.9 to 1.3 mg/mL ascorbic acid, 1 to 2 mg/mL maltose (dosimetric dose) or 9 to 15 mg/mL maltose (therapeutic dose), 4.4% to 6.6% (w/v) povidone, and 8.5 to 9.5 mg/mL sodium chloride. The pH is approximately 7.0.

Physical/Radiochemical Characteristics of Iodine-131: Iodine-131 decays with beta and gamma emissions with a physical half-life of 8.04 days. The principal beta emission has a mean energy of 191.6 keV, and the principal gamma emission has energy of 364.5 keV.

External Radiation: The specific gamma ray constant for Iodine-131 is 2.2 R/millicurie hour at 1 cm. Use a 2.55 cm thickness of Pb (to attenuate the radiation emitted by a factor of about 1,000) to minimize radiation exposure from this radionuclide.

The fraction of Iodine-131 radioactivity that remains in the vial x days after the date of calibration is 2-(x/8.04).

Physical decay is presented in Table 5.

Table 5. Physical Decay Chart: Iodine-131: Half-Life 8.04 Days

Days

Fraction Remaining

0a

1.000

1

0.917

2

0.842

3

0.772

4

0.708

5

0.650

6

0.596

7

0.547

8

0.502

9

0.460

10

0.422

11

0.387

12

0.355

13

0.326

14

0.299

a Calibration day.

Bexxar Manufacturers


  • Glaxosmithkline Llc
    Bexxar (Tositumomab) Kit Bexxar Dosimetric (Tositumomab I-131) Injection Bexxar Therapeutic (Tositumomab I-131) Injection [Glaxosmithkline Llc]

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