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Bexxar Dosimetric Side Effects

Generic name: tositumomab

Note: This document contains side effect information about tositumomab. Some dosage forms listed on this page may not apply to the brand name Bexxar Dosimetric.

Applies to tositumomab: intravenous solution.

Warning

Intravenous route (Solution)

Serious Allergic Reactions: Immediately interrupt infusion and permanently discontinue the tositumomab and iodine I 131 tositumomab therapeutic regimen for serious allergic reactions. Prolonged and severe cytopenias occur in most patients. Tositumomab and iodine I 131 tositumomab should not be administered to patients with greater than 25% lymphoma marrow involvement, platelet count less than 100,000 cells/mm(3), or neutrophil count less than 1500 cells/mm(3). The tositumomab and iodine I 131 tositumomab therapeutic regimen is supplied only to certified healthcare professionals. Follow institutional radiation safety practices and applicable federal guidelines to minimize radiation exposure to household contacts and medical staff.

Intravenous route (Solution)

Serious Allergic Reactions: Immediately interrupt infusion and permanently discontinue the tositumomab and iodine I 131 tositumomab therapeutic regimen for serious allergic reactions. Prolonged and severe cytopenias occur in most patients. Tositumomab and iodine I 131 tositumomab should not be administered to patients with greater than 25% lymphoma marrow involvement, platelet count less than 100,000 cells/mm(3), or neutrophil count less than 1500 cells/mm(3). The tositumomab and iodine I 131 tositumomab therapeutic regimen is supplied only to certified healthcare professionals. Follow institutional radiation safety practices and applicable federal guidelines to minimize radiation exposure to household contacts and medical staff.

Serious side effects of Bexxar Dosimetric

Along with its needed effects, tositumomab (the active ingredient contained in Bexxar Dosimetric) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking tositumomab:

More common

Less common

Other side effects of Bexxar Dosimetric

Some side effects of tositumomab may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Less common

For Healthcare Professionals

Applies to tositumomab: intravenous kit.

Cardiovascular

Common (1% to 10%): Hypotension, vasodilation[Ref]

Dermatologic

Very common (10% or more): Rash, pruritus

Common (1% to 10%): Sweating[Ref]

Endocrine

Common (1% to 10%): Hypothyroidism[Ref]

Gastrointestinal

Very common (10% or more): Abdominal pain, nausea, vomiting, diarrhea, anorexia

Common (1% to 10%): Constipation, dyspepsia[Ref]

Hematologic

Very common (10% or more): Neutropenia, thrombocytopenia, anemia[Ref]

Hypersensitivity

Common (1% to 10%): Allergic (hypersensitivity) reactions (allergic reaction, facial edema, injection site hypersensitivity, anaphylactic reaction, laryngismus, serum sickness)

Postmarketing reports: Hypersensitivity reactions including fatal anaphylaxis[Ref]

Immunologic

Very common (10% or more): Positive serology for human anti-mouse antibodies (HAMA)[Ref]

Local

Frequency not reported: Infusion reactions[Ref]

Metabolic

Common (1% to 10%): Peripheral edema, weight loss[Ref]

Musculoskeletal

Very common (10% or more): Myalgia, arthralgia

Common (1% to 10%): Back pain, neck pain[Ref]

Nervous system

Common (1% to 10%): Dizziness, somnolence

Postmarketing reports: Axonal neuropathy leading to quadriparesis[Ref]

Oncologic

Common (1% to 10%): Secondary malignancies (non-melanoma skin, colorectal, head and neck, breast, lung, bladder, melanoma, gastric)

Frequency not reported: Secondary leukemia, myelodysplastic syndrome[Ref]

Other

Very common (10% or more): Asthenia, fever, infections, pain, chills, headache

Common (1% to 10%): Chest pain, serious infections (pneumonia, bacteremia, septicemia, bronchitis, skin infections)[Ref]

Respiratory

Very common (10% or more): Cough, pharyngitis, dyspnea, rhinitis

Common (1% to 10%): Pneumonia[Ref]

References

1. Product Information. Bexxar I 131 Therapeutic (iodine I 131 tositumomab). GlaxoSmithKline. 2022.

2. Product Information. BexxarTherapy (tositumomab). GlaxoSmithKline Inc. 2006.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.