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IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

IBRITUMOMAB TIUXETAN - INJECTION

(ih-brih-TOO-mow-mab tie-ooh-X-eh-tan)

COMMON BRAND NAME(S): Zevalin

WARNING: Rituximab, a medication that is used along with ibritumomab tiuxetan, may infrequently cause serious (sometimes fatal) side effects, including severe breathing problems (e.g., hypoxia, pulmonary infiltrates, acute respiratory distress syndrome) or heart problems (e.g., heart attack, irregular heartbeat, low blood pressure). These effects usually occur within 30 minutes to 2 hours of receiving rituximab. The risk of these effects is greater during your first treatment. Seek immediate medical attention if you have any of the following signs: trouble breathing (e.g., shortness of breath, wheezing), itching, swelling (especially of the throat/lips), severe dizziness, fast/slow/irregular heartbeat, chest pain.

This medication may cause very serious blood disorders (decreased bone marrow function leading to low number of blood cells such as red cells, white cells, and platelets). This effect can cause anemia, decrease your body's ability to fight an infection, or cause your body to bruise or bleed more easily. Tell your doctor immediately if you develop any of the following symptoms: signs of infection (e.g., fever, persistent sore throat), easy bruising/bleeding, unusual tiredness, fast/pounding heartbeat.

Rarely, serious (sometimes fatal) skin reactions (e.g., Stevens-Johnson syndrome) have occurred in patients receiving this treatment program. These reactions can occur during treatment or days to months after treatment is finished. Seek immediate medical attention if you develop a rash or pain/swelling of the mouth/tongue/throat/eyes. If you have previously had a severe skin reaction due to ibritumomab tiuxetan or the other medication(s) used in the treatment program (e.g., rituximab, indium, yttrium), do not start this treatment program again. Consult your doctor or pharmacist for more details.

USES: This medication is combined with certain radioactive substances (Indium-111, Yttrium-90) and used along with rituximab to treat a certain type of cancer (B-cell non-Hodgkin's lymphoma) in patients whose cancer has returned or has not responded to other treatments. Ibritumomab tiuxetan and rituximab are known as monoclonal antibodies. They work by killing certain blood and cancer cells from your immune system (B cells). Yttrium-90 helps kill the cancer cells, and Indium-111 helps to show how the medication is spread throughout the body (imaging studies).

HOW TO USE: This medication is given by injection into a vein by a health care professional.

Dosage is based on your medical condition, weight, and response to treatment. This medication is usually given as 2 doses. It is always given within 4 hours after rituximab. The first dose of this medication is combined with Indium-111. A test is done usually 48 to 72 hours after your dose to determine how the medication has spread throughout the body. If the test shows that the medication has spread properly, another dose of this medication (combined with Yttrium-90) is given 7 to 9 days after the first dose.