Ibritumomab Tiuxetan


|Ibritumomab Tiuxetan

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Ibritumomab Tiuxetan

Pronouncation: (EYE-bri-TOOM-oh-mab tye-UX-e-tan)
Class: Monoclonal antibody

Trade Names:
- Injection 3.2 mg

Mechanism of Action


Ibritumomab is a monoclonal antibody directed against the CD20 antigen found on the surface of normal and malignant B lymphocytes. The CD20 antigen is also expressed on more than 90% of B-cell non-Hodgkin lymphomas.



The mean fraction of injected activity in the blood AUC is 39 hr.


The mean effective t ½ for Y-90 activity in the blood is 30 hr. Over 7 days, a median of 7.2% of injected activity is excreted in urine.


At 4 wk, the median number of circulating B cells is zero (range, 0 to 1,084 cells/mm 3 ).


B-cell recovery begins at approximately 12 wk following treatment, and the median level of B cells is within the normal range (32 to 341 cells/mm 3 ) by 9 mo after treatment.

Indications and Usage

Treatment of patients with relapsed or refractory low-grade, follicular, or transformed B-cell non-Hodgkin lymphoma.


Patients with known type I hypersensitivity or anaphylactic reactions to murine proteins or to any component of the therapeutic regimen.

Dosage and Administration


IV The therapeutic regimen consists of 2 steps. Step 1 includes a single infusion of rituximab 250 mg/m 2 (not included in the therapeutic kit) preceding a fixed dose of indium-111 (In-111) ibritumomab tiuxetan 5 mCi (1.6 mg total antibody dose) administered as a 10min IV push. Step 2 follows step 1 by 7 to 9 days and consists of a second infusion of rituximab 250 mg/m 2 prior to yttrium-90 (Y-90) ibritumomab tiuxetan 0.4 mCi/kg as a 10min IV push. Reduce the Y-90 ibritumomab tiuxetan dose to 0.3 mCi/kg (11.1 MBq/kg) for patients with a baseline platelet count between 100,000 and 149,000 cells/mm 3 .

General Advice

  • For IV administration only.
  • Inject In-111 or Y-90 ibritumomab tiuxetan within 4 hr following completion of the rituximab dose.
  • Prior to injection of In-111 or Y-90 ibritumomab tiuxetan, a 0.22 micrometer low-protein-binding filter should be in-line between the syringe and the infusion port. After injection, flush the line with at least 10 mL of isotonic sodium chloride solution.
  • Establish a free-flowing IV line prior to Y-90 ibritumomab tiuxetan injection.


Store at 36°F to 46°F. Do not freeze. Store In-111 ibritumomab tiuxetan at 36° to 46°F until use and administer within 12 hr of radiolabeling. Store Y-90 ibritumomab tiuxetan at 36° to 46°F until use and administer within 8 hr of radiolabeling.

Drug Interactions

None well documented. However, because of the frequent occurrence of severe and prolonged thrombocytopenia, the potential benefits of medications that interfere with platelet function or anticoagulation should be weighed against the potential increased risk of bleeding and hemorrhage.

Laboratory Test Interactions

None well documented.

Adverse Reactions


Hypotension (6%); tachycardia (less than 1%).


Headache (12%); dizziness (10%); insomnia (5%); anxiety (4%); encephalopathy, subdural hematoma (less than 1%).


Pruritus (9%); rash (8%); flushing (6%); petechiae, sweats, urticaria (1% to 4%); cutaneous and mucocutaneous events (postmarketing).


Throat irritation (10%); epistaxis (3%).


Nausea (31%); vomiting (12%); diarrhea (9%); anorexia (8%); abdominal enlargement, constipation (5%); dyspepsia, melena (1% to 4%); GI hemorrhage (1%).


Vaginal hemorrhage (less than 1%).


Thrombocytopenia (95%); neutropenia (77%); anemia, platelet count below 50,000 cells/mm 3 (61%); absolute neutrophil count below 1,000 cells/mm 3 (57%); ecchymosis (7%); pancytopenia (2%).


Peripheral edema (8%); angioedema (5%).


Back pain (8%); arthralgia, myalgia (7%); arthritis (less than 1%).


Dyspnea (14%); increased cough (10%); rhinitis (6%); bronchospasm (5%); apnea (1%); lung edema, pulmonary embolus (less than 1%).


Asthenia (43%); infection (29%); chills (24%); fever (17%); abdominal pain (16%); pain (13%); allergic reactions, secondary malignancies (2%); tumor pain (1%); hematemesis (less than 1%).



Fatal infusion reaction

Death within 24 hr of rituximab infusion, an essential component of ibritumomab therapeutic regimen, has occurred. These fatalities were associated with an infusion reaction symptom complex that included hypoxia, pulmonary infiltrates, acute respiratory distress syndrome, MI, ventricular fibrillation, and cardiogenic shock. Approximately 80% of fatal infusion reactions occurred in association with the first rituximab infusion.


Administration of Y-90 ibritumomab tiuxetan results in severe and prolonged cytopenias in most patients.

Cutaneous reactions

Severe cutaneous and mucocutaneous reactions, some fatal, have been reported in association with the ibritumomab tiuxetan treatment regimen.

Special requirements

Only health care providers qualified by training in the safe use and handling of radionuclides should administer In-111 and Y-90 ibritumomab tiuxetan.


Obtain platelet and CBC counts weekly following the ibritumomab tiuxetan therapeutic regimen and continue until levels recover. Monitor platelets and CBC more frequently in patients who develop severe cytopenia. Patients receiving medications that interfere with platelet function or coagulation should have more frequent laboratory monitoring for thrombocytopenia.


Category D .




Safety and efficacy not established.


Do not administer Y-90 ibritumomab tiuxetan to patients with altered biodistribution of In-111 ibritumomab tiuxetan


Hypersensitivity reactions, including anaphylaxis, may occur.


Because this product contains albumin, a derivative of human blood, there is a risk of transmitting infectious agents (eg, viruses), including Creutzfeldt-Jakob disease.

Radionuclide precautions

The ibritumomab tiuxetan kit is not radioactive. However, during and after radiolabeling ibritumomab tiuxetan with In-111 or Y-90, take care to minimize radiation exposure of patients and medical personnel.

Secondary malignancies

Acute myelogenous leukemia and myelodysplastic syndrome have been reported following the ibritumomab tiuxetan therapeutic regimen.



Hematologic toxicity.

Patient Information

  • Explain name, dose, action, and potential adverse reactions of drug.
  • Obtain patient history, including drug history and any known allergies.
  • Advise women to avoid becoming pregnant, and to use effective contraceptive methods during treatment and for up to 12 mo following the ibritumomab tiuxetan therapeutic regimen.
  • Advise women to notify health care provider if pregnant, planning to become pregnant, or breast-feeding.
  • Caution patient to not take any prescription or OTC medications, herbal preparations, or dietary supplements unless advised by health care provider.
  • Advise patient that follow-up visits may be necessary and to keep appointments.

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