Ibritumomab

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

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

Ibritumomab may also be used for reasons not mentioned in this medication guide.

Ibritumomab is used along with rituximab (Rituxan) and a radioactive chemical. Ibritumomab is given as an infusion into a vein. A healthcare provider will give you this injection.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when ibritumomab is injected.

You may receive medication to prevent some side effects while you are getting ibritumomab. Take all of the medicines your doctor has prescribed.

Ibritumomab can increase your risk of bleeding or infection. You will need frequent medical tests.

Life-threatening reactions may happen during the injection or within 24 hours afterward. Inform your caregivers or get medical help if you feel light-headed or short of breath, or if you experience chest tightness or pain that spreads to your jaw or shoulder.

Serious and sometimes fatal infections or skin reactions may occur during treatment with ibritumomab, and up to 4 months afterward. Contact your doctor immediately if you have: fever, chills, mouth sores, pale skin, cold hands and feet, feeling light-headed or short of breath, easy bruising or bleeding, or skin changes at the injection site.

You should not be treated with ibritumomab if you are allergic to ibritumomab, or to radioactive chemicals or mouse proteins.

Tell your doctor if you have ever had:

• any type of infection;
• bleeding or blood clotting problems;
• breathing problems; or
• if you take a blood thinner (warfarin, Coumadin) or other medicine to prevent blood clots.

Using ibritumomab may increase your risk of developing other types of cancer, such as leukemia or preleukemia. Ask your doctor about your specific risk.

You may need to have a negative pregnancy test before starting this treatment.

Both men and women using this medicine should use effective birth control to prevent pregnancy. Ibritumomab can harm an unborn baby or cause birth defects if the mother or father is using this medicine. Keep using birth control for at least 12 months after your last dose.

Tell your doctor right away if a pregnancy occurs while either the mother or the father is using ibritumomab.

Do not breastfeed while using this medicine, and for at least 6 months after your last dose.

Get emergency medical help if you have signs of an allergic reaction (hives, trouble breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Life-threatening reactions may happen during the injection or within 24 hours afterward. Tell your caregivers or seek medical help if you feel light-headed or short of breath, or if you have chest tightness or pain that spreads to your jaw or shoulder.

Serious and sometimes fatal infections or skin reactions may happen during treatment with ibritumomab, and up to 4 months afterward. Call your doctor right away if you have:

• redness, ulcers, or skin changes where the medicine was injected;
• easy bruising, unusual bleeding, purple or red spots under your skin;
• unusual weakness or tiredness;
• low red blood cells (anemia)--pale skin, weakness, cold hands and feet; or
• low white blood cell counts--fever, mouth sores, skin sores, sore throat, cough, trouble breathing.

Common side effects of ibritumomab may include:

• nausea, stomach pain, diarrhea;
• fever, cough;
• stuffy nose, sore throat, sinus pain; or
• feeling weak or tired.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for non-Hodgkin's Lymphoma:

Day 7, 8, or 9 following initial rituximab infusion:-Within 4 hours of rituximab, administer Y-90 ibritumomab 0.4 mCi/kg (14.8 MBq/kg) actual body weight intravenously over 10 minutes for patients with normal platelet count (Platelet count greater than 150,000/mm3).Maximum dose: 32 mCi (1184 MBq) Y-90 ibritumomab dose regardless of actual body weight.Comments:-Do not treat if platelets less than 100,000/mm3-Initiate the regimen following recovery of platelet counts to at least 150,000/mm3 at least 6 weeks, but not more than 12 weeks, following the last dose of first-line chemotherapy

Call your doctor for instructions if you miss an appointment for your Ibritumomab injection.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid close contact with people who are sick or have infections. Inform your doctor immediately if you notice any signs of infection.

Do not receive a "live" vaccine while using ibritumomab, and for at least 12 months after your treatment ends. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), and nasal flu (influenza) vaccine.

Other drugs may impact ibritumomab, including prescription and over-the-counter medicines, vitamins, and herbal products. Inform your doctor about all the medicines you are currently taking and any new medicines you begin or stop using.