Drug Notebook

FDA Alerts

    Experience of Supervising Clinician
  • Use only by qualified clinicians experienced in the safe use and handling of radionuclides.

    Rituximab-related Infusion Reactions
  • Fatalities have occurred within 24 hours following rituximab infusion, an essential component of the ibritumomab tiuxetan therapeutic regimen.
  • Fatalities were associated with an infusion reaction symptom complex that included hypoxia, pulmonary infiltrates, acute respiratory distress syndrome, MI, ventricular fibrillation, and/or cardiogenic shock.
  • Approximately 80% of fatal infusion reactions occurred in association with initial infusion of rituximab.
  • If severe infusion-related effects develop, discontinue rituximab, indium In 111 ibritumomab tiuxetan, and yttrium Y 90 ibritumomab tiuxetan, and initiate appropriate therapy. (See Infusion-related Effects under Cautions.)

    Cytopenias
  • Most patients receiving the ibritumomab tiuxetan therapeutic regimen develop prolonged and severe cytopenias.
  • Do not use in patients with ≥25% lymphoma marrow involvement and/or impaired bone marrow reserve. (See Hematologic Effects under Cautions.)

    Severe Cutaneous and Mucocutaneous Reactions
  • Severe, sometimes fatal, cutaneous and mucocutaneous reactions reported. (See Severe Cutaneous and Mucocutaneous Reactions under Cautions.)
  • Patients experiencing a severe cutaneous or mucocutaneous reaction should not receive any further components of the ibritumomab tiuxetan therapeutic regimen and should promptly seek medical evaluation.

    Yttrium Y 90 Ibritumomab Tiuxetan
  • Do not administer yttrium Y 90 ibritumomab tiuxetan to patients with altered distribution as determined by imaging with indium In 111 ibritumomab tiuxetan.
  • Dosage of yttrium Y 90 ibritumomab tiuxetan must not exceed 32 mCi.

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ibritumomab
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(ib ri TYOO mo mab)

What is the most important information I should know about ibritumomab?

Do not receive this medication if you are pregnant. It could cause harm to the unborn baby. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

Ibritumomab can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Contact your doctor immediately if you develop signs of infection.

Do not receive a "live" vaccine while you are being treated with ibritumomab, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you.

Some people receiving ibritumomab have developed "secondary" bone marrow or blood cell cancers such as leukemia. Talk with your doctor about your individual risk while receiving this medication.

What is ibritumomab?

Ibritumomab is a protein that targets white blood cells in the body. When ibritumomab is attached to a radioactive chemical, the radiation is delivered directly to the tumor (lymphoma).

Ibritumomab is used in combination with other medicines to treat non-Hodgkin's lymphoma.

Ibritumomab may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before receiving ibritumomab?

You should not receive this medication if you are allergic to ibritumomab, or to radioactive chemicals or mouse proteins.

Before you receive ibritumomab, tell your doctor if you are allergic to any drugs, or if you have:

If you have any of these conditions, you may need a dose adjustment or special tests to safely receive ibritumomab.

FDA pregnancy category D. This medication can cause harm to an unborn baby. Do not receive ibritumomab if you are pregnant. Tell your doctor if you become pregnant during treatment. Use an effective form of birth control while you are receiving this medication. It is not known whether ibritumomab passes into breast milk or if it could harm a nursing baby. Do not receive ibritumomab without telling your doctor if you are breast-feeding a baby.

Ibritumomab is made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

Some people receiving ibritumomab have developed "secondary" bone marrow or blood cell cancers such as leukemia. Talk with your doctor about your individual risk while receiving this medication.

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