IBRITUMOMABTIUXETAN (Systemic)?

Some commonly used brand names are:

In the U.S.?

• Zevalin

Other commonly used names are:

• IDEC-2B8 (ibritumomab tiuxetan)
• IDEC-Y2B8 (yttrium-90-ibritumomab tiuxetan)
• IDEC-In2B8 (indium-111-ibritumomab tiuxetan)
• IDEC-129

? Not commercially available in Canada.

Category

• Monoclonal antibody
• antineoplastic (radioactive)

Description

Ibritumomab Tiuxetan (ib-ri-TU-moe-mab) (tie-ux-EH-tan) is aprotein called a monoclonal antibody. It is used along with another monoclonalantibody (rituximab) and two radioactive pharmaceuticals (In-111 and Y-90).Ibritumomab tiuxetan is used to treat a type of cancer called non-Hodgkin'slymphoma.

Ibritumomab Tiuxetan is to be administered only by or under the immediatesupervision of your doctor. It is available in the following dosage form:

Parenteral
• Injection (U.S.)

Before Using This Medicine

In deciding to use a medicine,the risks of taking the medicine must be weighed against the good it willdo. This is a decision you and your doctor will make. For ibritumomab tiuxetan,the following should be considered:

Allergies?Tell your doctor if you have ever had any unusual reactionto ibritumomab tiuxetan, rituximab, yttrium chloride, indium chloride or tomouse proteins.

Pregnancy?Ibritumomab tiuxetan is not recommended during pregnancy.It has been shown to cause birth defects. However, this medicine may be neededin serious diseases or other situations that threaten the mother's life. Besure you have discussed this with your doctor.

Women who are able to bear children should use some kind of birth controlduring treatment with ibritumomab tiuxetan and for up to 12 months after treatmenthas ended.

Before receiving this medicine, make sure your doctor knows if you arepregnant.

Tell your doctor right away if you think you have become pregnant whilereceiving ibritumomab tiuxetan.

Breast-feeding?It is not known whether ibritumomab tiuxetan passesinto the breast milk. However, because of the possibility of serious effects,breast-feeding is not recommended while you are receiving this medicine.

Children?Studies on this medicine have been done only in adultpatients, and there is no specific information comparing use of ibritumomabtiuxetan in children with use in other age groups.

Older adults?This medicine has been tested in a limited numberof patients 65 years of age or older and has not been shown to cause differentside effects or problems in older people than it does in younger adults.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takingibritumomab tiuxetan, it is especially important that your doctor and pharmacistknow if you are taking any of the following:

• Anticoagulants (blood thinners such as warfarin [Coumadin]) or
• Medicines that prevent platelets from sticking together (clopidogrel[e.g., Plavix], ticlopidine [e.g., Ticlid])?Use with ibritumomab tiuxetanmay increase the risk of bleeding.

• If you have ever been treated with radiation or cancer medicines?Ibritumomabtiuxetan may increase the effects of these medicines on the blood.

Other medical problems?The presence of other medicalproblems may affect the use of ibritumomab tiuxetan. Make sure you tell yourdoctor if you have any other medical problems, or sensitivity or a previoussevere allergic reaction to ibritumomab tiuxetan, rituximab, yttriumchloride, indium chloride or to mouse proteins.

Proper Use of This Medicine

Dosing?The dose of ibritumomab tiuxetan will be different for differentpatients. The dose that is used may depend on a number of things, includingyour size. Ibritumomab tiuxetan is usually given by a doctor in the hospitalor an outpatient clinic. If you have any questions about the proper doseof ibritumomab tiuxetan, ask your doctor.

Precautions While Using This Medicine

It is very important that yourdoctor check your progress at regular visits to make sure that thismedicine is working properly and to check for unwanted effects.

While you are being treated with ibritumomab tiuxetan, and after you stoptreatment with it, do not have any immunizations (vaccinations)without your doctor's approval. Ibritumomab tiuxetan may lower yourbody's resistance and there is a chance you might get the infection the immunizationis meant to prevent. In addition, other persons living in your household shouldnot take oral polio vaccine since there is a chance they could pass the poliovirus on to you. Also, avoid persons who have taken oral polio vaccine withinthe last several months. Do not get close to them, and do not stay in thesame room with them for very long. If you cannot take these precautions, youshould consider wearing a protective face mask that covers the nose and mouth.

Ibritumomab tiuxetan can temporarily lower the number of white blood cellsin your blood, increasing the chance of getting an infection. It can alsolower the number of platelets, which are necessary for proper blood clotting.If this occurs, there are certain precautions you can take, especially whenyour blood count is low, to reduce the risk of infection or bleeding:

• Avoid people with infections. Check with yourdoctor immediately if you think you are getting an infection or ifyou get a fever or chills, cough or hoarseness, lower back or side pain, orpainful or difficult urination.
• Check with your doctor immediately ifyou notice any unusual bleeding or bruising; black, tarry stools; blood inurine or stools; or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick.Your medical doctor, dentist, or nurse may recommend other ways to clean yourteeth and gums. Check with your medical doctor before having any dental workdone.
• Do not touch your eyes or the inside of your nose unless you havejust washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects suchas a safety razor or fingernail or toenail cutters.
• Avoid sports or other situations where bruising or injury could occur.

Side Effects of This Medicine

Along with its needed effects, a medicine maycause 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 as soon as possibleif any of the following side effects occur:

More common

Black, tarry stools; bleeding gums; blood in urine or stools; cough or hoarseness; coughing up blood; difficultyin breathing or swallowing; dizziness; fever or chills; headache; increased menstrual flow or vaginal bleeding; large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs,feet, sex organs; lower back or side pain; noisy breathing; nosebleeds; painful or difficult urination; paleskin; paralysis; pinpointred spots on skin; prolonged bleeding from cuts; red stools; red or dark brown urine; shortness of breath; sore throat; sores, ulcers, or white spots on lipsor in mouth; swollen glands; tightness in chest; troubled breathing with exertion; unusual bleeding or bruising; unusual tiredness or weakness; wheezing

Less common

Bloody nose that does not stop after pinching the nasal alaetogether and holding them continuously for 5 to 10 minutes; bluish lips or skin; chest pain or discomfort; confusion; diarrhea; fainting; fast heartbeat; hives; itching; lightheadedness; not breathing; pain atsite of tumor; puffiness or swelling of the eyelidsor around the eyes, face, lips or tongue; rapid,shallow breathing; skin rash; small red or purple spots on skin; unusual vaginalbleeding; vomiting blood or material that looks likecoffee grounds

Rare

Agitation; anxiety; back pain; blurred vision; coma; drowsiness; fast,pounding, or irregular heartbeat or pulse; hallucinations; inability to speak; irregularheartbeat; irritability; mood or mental changes; nausea; redness of skin; seizures; severe headache; slurred speech; stiff neck; temporary blindness; vomiting; weakness in arm and/or leg on one sideof the body, sudden and severe; welts

Other side effects may occur that usually do not need medical attention.These side effects may go away during treatment as your body adjusts to themedicine. However, check with your doctor if any of the following side effectscontinue or are bothersome:

More common

Abdominal pain or stomach pain; bruising; constipation; difficultor labored breathing; difficulty in moving; faintness or lightheadedness when getting up from a lying orsitting position; fear; feeling of warmth; full or bloated feeling or pressurein the stomach; joint pain; lack or loss of strength; large, flat, blue or purplishpatches in the skin; loss of appetite; muscle aching or cramping; muscle painor stiffness; nervousness; pain; pain in joints; rash; redness of the face, neck, arms and occasionally,upper chest; runny nose; sleeplessness; sneezing; stuffy nose; sudden or increased sweating; swollen joints; swelling of abdominalor stomach area; swelling of hands, ankles, feet,or lower legs; throat irritation; trouble sleeping; unable to sleep; weight loss

Less common

For several months after receiving this therapy, it may stillproduce some side effects that need attention. During this period of time check with your doctor immediately if you noticeany of the following:

Bleeding gums; blurred vision; bone pain; chills; confusion; cough; coughing up blood; difficultyin breathing or swallowing; dizziness; fainting; fast heartbeat; fever; headache, sudden and severe; inability to speak; increased menstrualflow or vaginal bleeding; lightheadedness; lower back or side pain; nosebleeds; painful or difficult urination; pale skin; paralysis; prolongedbleeding from cuts; rapid, shallow breathing; red or dark brown urine; red or black,tarry stools; secondary malignancy; seizures; shallow breathing; shortness of breath; slurred speech; sore throat; temporaryblindness; ulcers, sores, or white spots in mouth; unusual bleeding or bruising; unusual tiredness or weakness ; weakness in arm and/orleg on one side of body, sudden and severe

Other side effects not listed above may also occur insome patients. If you notice any other effects, check with your doctor.