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|Tositumomab Tositumomab and Iodine 131I-Tositumomab

Tositumomab

Tositumomab is used for:

Treating certain forms of non-Hodgkin lymphoma in patients who have not responded to other therapy.

Tositumomab is a monoclonal antibody protein. It works by recognizing and sticking to a protein receptor on cancer cells and then killing the cancer cell.

Do NOT use Tositumomab if:

• you are allergic to any ingredient in Tositumomab or to murine proteins
• you have bone marrow depression or a blood disorder such as anemia, neutropenia, or thrombocytopenia
• you are unable to take a thyroid blocker (eg, methimazole)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Tositumomab :

Some medical conditions may interact with Tositumomab . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have an infection or thyroid problems
• if you are scheduled to receive a vaccine

Some MEDICINES MAY INTERACT with Tositumomab . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Medicines that decrease blood clotting (eg, aspirin, clopidogrel, ibuprofen, warfarin) and medicines that affect the immune system (eg, azathioprine, corticosteroids, cyclosporine) because serious side effects, such as risk of bleeding or infections, may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Tositumomab may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Tositumomab :

Use Tositumomab as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Tositumomab is usually administered as an injection at your doctor"s office, hospital, or clinic. Ask your doctor any question that you may have about Tositumomab .
• If you miss a dose of Tositumomab , contact your doctor right away.

Ask your health care provider any questions you may have about how to use Tositumomab .

Important safety information:

• Tositumomab may cause dizziness or drowsiness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Tositumomab . Using Tositumomab alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Tositumomab may reduce the number of certain blood cells, including red blood cells, white blood cells, and platelets. This may increase your risk of infection and bleeding. Prevent infection by avoiding contact with people with colds or other infections. Do not touch your eyes or the inside of your nose unless you have thoroughly washed your hands first. Notify your doctor of any signs of infection, including fever, sore throat, rashes, or chills. To prevent bleeding, avoid situations in which bruising or injury may occur. Report any unusual bleeding or bruising; blood in stools; or black, tarry stools to your doctor.
• Avoid vaccinations with live virus vaccines (eg, measles, mumps, oral polio) while you are taking Tositumomab .
• As with other cancer medicines, Tositumomab can cause a secondary cancer. Discuss the benefits and risks of using Tositumomab with your doctor.
• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Tositumomab .
• Tositumomab may reduce the levels of thyroid hormone your thyroid produces. Thyroid tests will be done before your doses and every year thereafter to monitor for any change in function of the thyroid gland.
• Some patients may develop an immune response called HAMA (human anti-murine antibody) after using Tositumomab . This antibody may interfere with certain lab test results. Be sure all of your doctors and laboratory personnel know that you are being treated, or have been treated, with Tositumomab .
• Both men and women capable of having children who receive Tositumomab should use reliable methods of birth control (eg, condoms) during and for at least 1 year after receiving Tositumomab .
• LAB TESTS, including complete blood cell counts, platelet counts, thyroid function tests, and kidney function tests, will be required to monitor your progress and check for side effects. Frequent monitoring will be done for up to 12 weeks after treatment. Be sure to keep all doctor and lab appointments.
• Caution is advised when using Tositumomab in the ELDERLY because they may be more sensitive to the effect Tositumomab has on blood cells.
• PREGNANCY and BREAST-FEEDING: It is unknown if Tositumomab can cause harm to the fetus. If you become pregnant while taking Tositumomab , discuss with your doctor the benefits and risks of using Tositumomab during pregnancy. Tositumomab is most likely excreted in breast milk. Do not breast-feed while receiving Tositumomab .

Possible side effects of Tositumomab :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; headache; muscle aches; nausea; pain, swelling, or redness at the injection site; stomach upset; vomiting.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black stools; easy bruising or bleeding; fast heartbeat; flu-like symptoms such as chills, cough, or sweating; infection; itching; lightheadedness; loss of appetite; lung infection; new growths or lumps; pain, including chest, stomach, muscle, neck, back, or joint pain; pale skin; persistent sore throat or fever; shortness of breath; sudden weight loss; swelling of the hands or feet; unusual tiredness or weakness; vomit that looks like coffee grounds.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Tositumomab is usually handled and stored by a health care professional. Keep Tositumomab out of reach of children and away from pets.

General information:

• If you have any questions about Tositumomab , please talk with your doctor, pharmacist, or other health care provider.
• Tositumomab is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Tositumomab . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.