I-131 Tositumomab (Murine) Solution for injection

What is this medicine?

TOSITUMOMAB (TOE sih too MOE mab) is a chemotherapy drug. This medicine allows radiation to target specific kinds of white blood cells. It is used to treat non-Hodgkin's lymphoma.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• blood disorders
• infection (especially a virus infection such as chickenpox, cold sores, or herpes)
• kidney disease
• low blood counts
• an unusual or allergic reaction to tositumomab, mouse proteins, medicines used for bone scans, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

This medicine is for infusion into a vein. It is administered in a hospital or clinic by a specially trained health care professional.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss a dose. Call your doctor or health care professional if you are unable to keep an appointment.

What may interact with this medicine?

• medicines that treat or prevent blood clots like warfarin, enoxaparin, and dalteparin
• vaccines

Talk to your doctor or health care professional before taking any of these over-the-counter medicines:

• acetaminophen
• aspirin
• ibuprofen
• ketoprofen
• naproxen

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Report any side effects that you notice during your treatment right away, such as changes in your breathing, fever, chills, dizziness or lightheadedness. These effects are more common with the first dose.

Visit your prescriber or health care professional for checks on your progress. You will need to have regular blood work. Report any other side effects. The side effects can continue after you finish your treatment. Continue your course of treatment even though you feel ill unless your doctor tells you to stop.

Call your doctor or health care professional for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This drug decreases your body's ability to fight infections. Try to avoid being around people who are sick.

This medicine may increase your risk to bruise or bleed. Call your doctor or health care professional if you notice any unusual bleeding.

Be careful brushing and flossing your teeth or using a toothpick because you may get an infection or bleed more easily. If you have any dental work done, tell your dentist you are receiving this medicine.

Avoid taking products that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your doctor. These medicines may hide a fever.

Men and women must use effective birth control while taking this medicine and for 12 months after completing therapy. Do not become pregnant while taking this medicine. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine.

After taking this medicine you will have radioactivity in your body for a period of time, usually for a week or two following the treatment. Your doctor or other health care provider will give you instructions about how to prevent exposing others to this radioactivity. Follow all instructions carefully.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• low blood counts - this medicine may decrease the number of white blood cells, red blood cells and platelets. You may be at increased risk for infections and bleeding.
• signs of infection - fever or chills, cough, sore throat, pain or difficulty passing urine
• signs of decreased platelets or bleeding - bruising, pinpoint red spots on the skin, black, tarry stools, blood in the urine
• signs of decreased red blood cells - unusually weak or tired, fainting spells, lightheadedness
• breathing problems
• chest pain
• feeling faint or lightheaded, falls
• swelling of the ankles, feet, or hands

Side effects that usually do not require medical attention (report to your doctor or other health care professional if they continue or are bothersome):

• anxiety
• constipation
• diarrhea
• flushing
• headache
• loss of appetite
• muscle aches
• nausea, vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

This drug is given in a hospital or clinic and will not be stored at home.

NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.