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|Bexxar

TOSITUMOMAB AND IODINE I 131 TOSITUMOMAB (Systemic)†

Some commonly used brand names are:

In the U.S.—

• Bexxar

† Not commercially available in Canada.

Category

• Antineoplastic (radioactive)
• Monoclonal antibody

Description

Tositumomab(( tos-IT-too-moe-mab)) and iodine ((EYE-oh-din)) I 131 tositumomab((tos-IT-too-moe-mab)) is a protein called a monoclonal antibody. It is used to treat a type of cancer called non-Hodgkin"s lymphoma.

Tositumomab and iodine I 131 tositumomab is to be administered only by or under the immediate supervision 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 using the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For tositumomab and iodine I 131 tositumomab, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to tositumomab, iodine I 131 tositumomab, or mouse proteins. Also tell your doctor and pharmacist if you are allergic to any other substances.

Pregnancy—Tositumomab and iodine I 131 tositumomab is not recommended during pregnancy. It has been shown to cause thyroid problems in the baby. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Women who are able to bear children should use some kind of birth control during treatment with this medicine and for up to 12 months after treatment has ended.

Breast-feeding—This medicine passes into breast milk and may cause unwanted effects in nursing babies. It may be necessary for you to take another medicine or to stop breast-feeding during treatment. Be sure you have discussed the risks and benefits of the medicine with your doctor.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of tositumomab and iodine I 131 tositumomab in children with use in other age groups.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of tositumomab and iodine I 131 tositumomab in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking tositumomab and iodine I 131 tositumomab, it is especially important that your doctor and pharmacist know if you are taking any of the following:

• Anticoagulants (blood thinners such as warfarin [e.g., Coumadin]) or
• Medicines that prevent platelets from sticking together (clopidogrel [e.g., Plavix], ticlopidine [e.g., Ticlid])—Use with tositumomab and iodine I 131 tositumomab may increase the risk of bleeding.

Other medical problems—The presence of other medical problems may affect the use of tositumomab and iodine I 131 tositumomab. Make sure you tell your doctor if you have any other medical problems, or bone marrow problems.

Proper Use of This Medicine

Dosing—The dose of tositumomab and iodine I 131 tositumomab will be different for different patients. The dose that is used may depend on a number of things, including your size. Tositumomab and iodine I 131 tositumomab is usually given by a doctor in the hospital or an outpatient clinic. If you have any questions about the proper dose of tositumomab and iodine I 131 tositumomab, ask your doctor.

Precautions While Using This Medicine

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

While you are being treated with tositumomab and iodine I 131 tositumomab, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor"s approval . Tositumomab and iodine I 131 tositumomab may lower your body"s resistance and there is a chance you might get the infection the immunization is meant to prevent.

Patients should be informed of the risks of hypothyroidism and be advised to take thyroid blocking agents during treatment.

Tositumomab and iodine I 131 tositumomab can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• Avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in urine 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 your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as 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 may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Developed: 04/25/2005

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