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Bexxar Generic Name & Formulations
Legal Class
Rx
General Description
Tositumomab 35mg/vial, 225mg/vial; soln; Iodine I131 tositumomab 0.61mCi/mL, 5.6mCi/mL soln; both for IV infusion after dilution; preservative-free.
Pharmacological Class
Radionuclide (B-lymphocyte-restricted differentiation antigen [CD20] inhibitor).
How Supplied
Dosimetric pack (tositumomab 2 x 225mg/vial + 1 x 35mg/vial and
Iodine I131 tositumomab 1 x 20mL single-use vial)—1; Therapeutic pack (tositumomab 2 x 225mg/vial + 1 x 35mg/vial and Iodine I131 tositumomab 1 or 2 x 20mL single-use vial)—1
Iodine I131 tositumomab 1 x 20mL single-use vial)—1; Therapeutic pack (tositumomab 2 x 225mg/vial + 1 x 35mg/vial and Iodine I131 tositumomab 1 or 2 x 20mL single-use vial)—1
Manufacturer
Bexxar Indications
Indications
Non-Hodgkin's lymphoma (CD20 antigen-expressing relapsed or refractory, low grade, follicular, transformed, or rituximab-refractory).
Bexxar Dosage and Administration
Adult
See full labeling. Pretreat with acetaminophen 650mg and oral diphenhydramine 50mg and thyroid blockers; continue thyroid blockers 2 weeks after therapeutic dose. Give by IV infusion. Dosimetric step: Tositumomab 450mg over 1hr, then Iodine I131 tositumomab (containing 5mCi I131 and 35mg tositumomab) over 20 minutes. Therapeutic step (7–14 days after dosimetric step if biodistribution acceptable): tositumomab 450mg over 1hr, then calculated therapeutic dose of Iodine I131 tositumomab over 20 minutes. Reduce infusion rate by 50% if infusional toxicity occurs; stop if severe; may continue at 50% rate if severe symptoms resolve.
Children
Not recommended.
Bexxar Contraindications
Contraindications
Hypersensitivity to murine proteins. Pregnancy (Cat.X).
Bexxar Boxed Warnings
Boxed Warning
Serious allergic reaction (including anaphylaxis). Prolonged and severe cytopenias. Radiation exposure.
Bexxar Warnings/Precautions
Warnings/Precautions
Use only by physicians trained in radionuclide therapy. Handle and dispose of properly. See full labeling on patient contact restrictions. Not for initial treatment. Have medical and supportive care available. Permanently discontinue if serious allergic reactions develop. >25% lymphoma marrow involvement and/or impaired bone marrow reserve, platelet count <100000cells/mm3, neutrophil count <1500cells/mm3, or intolerant to thyroid blockers: not recommended. High tumor burden. Splenomegaly. Renal impairment. Screen for human anti-mouse antibodies (increases anaphylaxis risk). Obtain CBCs and platelet counts before and for up to 12 weeks after therapy. Monitor TSH (before and annually), serum creatinine (before). Use adequate contraception during and for 12 months after therapy. Elderly. Nursing mothers: not recommended.
Bexxar Pharmacokinetics
See Literature
Bexxar Interactions
Interactions
Concomitant other forms of irradiation or chemotherapy: not recommended. Caution with live viral vaccines, anticoagulants, platelet aggregation inhibitors.
Bexxar Adverse Reactions
Adverse Reactions
Thrombocytopenia, neutropenia, anemia, headache, asthenia, fever, chills, pain, GI upset, cough, pneumonia, pleural effusion, dehydration, rash, infection, hemorrhage, allergic reactions (may be fatal), myelodysplastic syndrome, secondary malignancies, antibody formation.
Bexxar Clinical Trials
See Literature
Bexxar Note
Notes
For technical questions call (877) 423-9927.
Bexxar Patient Counseling
See Literature
