Tositumomab Injection 

(toe' sih too moe' mab)

IMPORTANT WARNING:

Tositumomab injection may cause serious or life-threatening allergic reactions. Tell your doctor if you are allergic to medications made from murine (mouse) proteins, or if you are not sure if a medication you are allergic to is made from murine proteins. Also tell your doctor if you have ever taken a medication made from murine proteins. If so, you may be more likely to have an allergic reaction to tositumomab injection. Your doctor will order tests to see if you are likely to have an allergic reaction to tositumomab injection.

Tell your doctor right away if you experience any of the following symptoms of allergic reaction while you are receiving a dose of tositumomab injection or during the first few days after you receive a dose of tositumomab injection: rash; hives; itching; swelling of the eyes, face, lips, tongue, throat, arms, hands, feet, ankles, or lower legs; tightening of the throat; wheezing; difficulty breathing or swallowing; or redness, swelling, or tenderness in the place where the medication was injected.

Treatment with tositumomab injection may cause a severe or life-threatening decrease in the number of blood cells in your body.This decrease in blood cells may happen 4 to 7 weeks after your treatment with tositumomab injection and may last for 30 days or longer. This decrease in blood cells may cause serious or life-threatening bleeding or infection. Your doctor will not give you tositumomab injection if your blood cells have been severely affected by cancer or if you already have a low number of blood cells. Tell your doctor if you are taking any of the following medications: anticoagulants ('blood thinners') such as warfarin (Coumadin); aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve); and clopidogrel (Plavix). If you have any of the following symptoms, call your doctor right away: pale skin; weakness; shortness of breath; unusual bruising or bleeding; or sore throat, fever, chills, cough, and other signs of infection.

Tell your doctor if you are pregnant or plan to become pregnant. Tositumomab injection may harm the fetus. If you are a female, your doctor will order a pregnancy test to be sure you are not pregnant before giving you tositumomab injection. Tositumomab injection may damage reproductive cells in men and women, so you will need to use birth control to prevent pregnancy in you or your partner during your treatment and for up to 12 months after your treatment. Talk to your doctor about an effective method of birth control to use during treatment with tositumomab. If you or your partner becomes pregnant during or up to 12 months after your treatment with tositumomab injection, call your doctor immediately.

Tositumomab injection is a radioactive medication. It may only be given by doctors who have been trained to give radioactive medications and who have been certified by the manufacturer of tositumomab injection to give the medication.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to check your body's response to tositumomab injection during your treatment and for at least 10 weeks after your treatment.

Talk to your doctor about the risks of receiving tositumomab injection.

WHY is this medicine prescribed?

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.

HOW should this medicine 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.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

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.
  • tell your doctor if you are breast-feeding.
  • 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.

What SPECIAL DIETARY instructions should I follow?

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

What should I do IF I FORGET to take a dose?

Call your doctor immediately if you are unable to keep an appointment to receive tositumomab injection.

What SIDE EFFECTS can this medicine 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].

What should I do in case of OVERDOSE?

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

  • pale skin
  • weakness
  • shortness of breath
  • unusual bruising or bleeding
  • sore throat, fever, chills, cough, and other signs of infection

What OTHER INFORMATION should I know?

Before having any laboratory test, tell your doctor and the laboratory personnel that you are receiving tositumomab injection or have received tositumomab injection in the past.

Ask your doctor or pharmacist any questions you have about tositumomab injection.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Brand Names
  • Bexxar®

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