Tositumomab Injection

Conditions Treated

Tositumomab injection is used to treat non-Hodgkin's lymphoma (cancer that begins in the cells of the immune system) that has not improved or that had improved after treatment with other medications, but later returned. Tositumomab injection is in a class of medications called monoclonal antibodies with radioisotopes. It works by attaching to cancer cells and releasing radiation to damage the cancer cells.

Possible Side Effects

What Side Effects Can This Cause?

Tositumomab injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• vomiting
• stomach pain
• diarrhea
• heartburn
• loss of appetite
• weight loss
• mouth sores
• sleepiness
• dizziness
• headache
• back or neck pain
• flushing
• hair loss

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

• chest pain
• tiredness or sluggishness
• feeling very uncomfortable in cold temperatures
• constipation
• pale, dry skin
• thin, brittle hair and nails
• puffy face
• hoarse voice
• weight gain
• muscle or joint pain or weakness
• depression
• heavy menstrual periods

Some people who received tositumomab injection developed other forms of cancer including leukemia (cancer that begins in the white blood cells), myelodysplastic syndrome (condition in which blood cells do not develop normally), skin cancer, and other types of cancer or tumors. Talk to your doctor about the risks of receiving tositumomab injection.Tositumomab injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].

Usage Instructions

How Should This Medication Be Used

Tositumomab injection comes as a liquid to be injected into a vein by a doctor who has been trained to treat patients with radioactive medication. It is given as part of a specific cancer treatment regimen. In order to receive the tositumomab injection treatment regimen, you will make 4 visits to the medical facility over 1 to 2 weeks. On the first visit, you will receive an infusion of tositumomab injection without radioactive material, followed by an infusion of tositumomab injection with radioactive material. The first infusion will last about 60 minutes, and the second infusion about 30 minutes. On the same day, you will undergo an imaging scan (test that shows a picture of all or part of the inside of the body) to see how tositumomab injection has spread through your body. On the second and third visits, you will undergo additional imaging scans to see how tositumomab injection has spread through your body. If tositumomab has spread through your body as expected, you will receive another infusion of tositumomab injection lasting 60 minutes, followed by an infusion of tositumomab injection with radioactive material lasting 30 minutes. You may experience unpleasant symptoms during or shortly after your infusion with tositumomab injection. Your doctor will give you medication before you receive tositumomab injection to help prevent these symptoms. If you experience any of these symptoms, tell your doctor right away: fever, chills, sweating, shortness of breath, tightening of the throat, or nausea.

What Dietary Instructions Should I Follow

Unless your doctor tells you otherwise, continue your normal diet.

Are There Any Special Instructions

Before receiving tositumomab injection, tell your doctor and pharmacist if you are allergic to tositumomab injection, any of the medications mentioned in the IMPORTANT WARNING section, any other medications, or any of the ingredients in tositumomab injection. Ask your doctor or pharmacist for a list of the ingredients. tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. tell your doctor if you have or have ever had kidney or thyroid disease. if you are having surgery, including dental surgery, tell the doctor or dentist that you have received tositumomab injection. do not have any vaccinations without talking to your doctor. you should know that the radioactive material in tositumomab injection may be present in your body for 1 to 2 weeks after you receive your last dose. You will need to take certain precautions to prevent the radiation from spreading to others who come in contact with you. Your doctor will explain these precautions to you and will also give you this information in writing. Follow these directions carefully, and ask your doctor if you have any questions. you should know that tositumomab injection may damage your thyroid gland. You will need to take medication to protect your thyroid gland beginning the day before you receive your first dose of tositumomab injection and continuing until 14 days after you receive the second dose of tositumomab injection. If you are unable to take the medication needed to protect your thyroid gland, your doctor will not give you tositumomab injection. After your treatment with tositumomab injection, you will need to visit your doctor once a year to check whether your thyroid gland has been damaged. If your thyroid gland is damaged, you will need to take a daily medication for the rest of your life. you should know that if you receive tositumomab injection, your body may develop antibodies (substances in the blood that help the immune system recognize and attack foreign substances) to murine proteins. If you develop these antibodies, you may have an allergic reaction when you take medications made from murine proteins, or these medications might not work well for you. After your treatment with tositumomab injection, be sure to tell all of your doctors that you have been treated with tositumomab injection.