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tositumomab

Pronunciation: TOE si too MOE mab

Brand: Bexxar Dosimetric, BexxarTherapeutic

What is the most important information I should know about tositumomab?

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You should not receive this medication if you are allergic to mouse proteins, or if you have ever had an allergic reaction to a monoclonal antibody.

Before you receive tositumomab, tell your doctor if you have kidney disease or severe bone marrow suppression.

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Tositumomab can cause damage to the thyroid gland of an unborn baby if the mother receives this medication during pregnancy. You should not receive this medication if you are pregnant.

Tositumomab can be harmful to an unborn baby whether the father or the mother receives this medication at the time of conception. Use effective birth control to prevent pregnancy during your treatment, whether you are a man or a woman. Continue using birth control for at least 12 months after you have received tositumomab.

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Tositumomab can lower blood cells that help your body fight infections. Your blood may need to be tested often. Avoid being near people who are sick or have infections. Avoid activities that may increase your risk of bleeding injury. Tell your doctor at once if you develop signs of infection.

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Do not receive a "live" vaccine just after you receive tositumomab.

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After you are treated with tositumomab, your body will retain radioactive material for several days. During this time you will be giving off a small amount of radiation to others around you. Your caregivers should give you instructions about how to avoid exposing other people to radiation until this effect wears off. Follow these instructions carefully.

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Take all medications your doctor prescribes to help protect your thyroid gland when you receive tositumomab. You may need to have blood tests to check your thyroid function at regular intervals for the rest of your life. Visit your doctor regularly.

What is tositumomab?

Tositumomab is a monoclonal antibody that is linked with radioactive iodine I-131. Monoclonal antibodies are made to target and destroy only certain cells in the body. This may help to protect healthy cells from damage.

Tositumomab is used to treat certain forms of non-Hodgkin's lymphoma. It is usually given after other medications have been tried without successful treatment.

Tositumomab may also be used for purposes not listed in this medication guide.

What should I discuss with my health care provider before I receive tositumomab?

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You should not receive this medication if you are allergic to mouse proteins, or if you have ever had an allergic reaction to a monoclonal antibody.

To make sure you can safely receive tositumomab, tell your doctor if you have any of these other conditions:

  • kidney disease; or
  • severe bone marrow suppression.
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FDA pregnancy category X. Tositumomab can cause damage to the thyroid gland of an unborn baby if the mother receives this medication during pregnancy. You should not receive this medication if you are pregnant.

Tositumomab can be harmful to an unborn baby whether the father or the mother receives this medication at the time of conception. Use effective birth control to prevent pregnancy during your treatment, whether you are a man or a woman. Continue using birth control for at least 12 months after you have received tositumomab.

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Tositumomab can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using tositumomab.

Some people treated with tositumomab later developed leukemia or other cancers. However, it has not been determined whether this medication actually increases the risk of causing other cancers. Talk with your doctor about your individual risk.

How is tositumomab given?

Tositumomab is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting. Tositumomab treatment consists of two different injections (tositumomab, and iodine I-131 tositumomab). These injections must be given one at a time and injected slowly through an IV infusion. The first injection is given over at least 60 minutes and the second injection is given over at least 20 minutes.

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Before and during your tositumomab treatment, you will be given other medications to protect your thyroid gland and to help prevent allergic reactions. You may need to keep taking some of these medications for up to 2 weeks after your treatment.

The tositumomab treatment is usually given in two steps over a span of 7 days. In the first treatment step, you will receive the two injections just before you undergo an x-ray scan of your entire body. This scan will show your doctor how well the radioactive ingredients of the tositumomab injections are circulating throughout your body. You may receive at least 2 more scans over the next 6 or 7 days.

Based on the results of your scans, your doctor will determine whether or not to give the second step of tositumomab treatment, and how large your dose should be.

In step 2 of the treatment, you will again receive the two injections one at a time. These injections are considered your therapeutic dose. The 2-step tositumomab treatment is usually given only once, so you are not likely to receive a second course of treatment with this medication.

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Tositumomab can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Your blood may need to be tested often. Visit your doctor regularly.

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Wash your hands often to prevent infections.

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After you are treated with tositumomab, your body will retain radioactive material for several days. During this time you will be giving off a small amount of radiation to others around you. Your caregivers should give you instructions about how to avoid exposing other people to radiation until this effect wears off.

Tositumomab can increase your risk of developing hypothyroidism (underactive thyroid). Hypothyroidism can be treated with daily thyroid replacement medication.

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Take all medications your doctor prescribes to help protect your thyroid gland when you receive tositumomab. You may need to have blood tests to check your thyroid function at regular intervals for the rest of your life. Visit your doctor regularly.

This medication can cause unusual results with certain medical tests. You may also have an allergic reaction to diagnostic tests or treatments using mouse proteins or monoclonal antibodies. Tell any doctor who treats you that you have been treated with tositumomab.

What happens if I miss a dose?

Because you will receive tositumomab in a clinical setting, you are not likely to miss a dose.

What happens if I overdose?

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What should I avoid after receiving tositumomab?

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

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Do not receive a "live" vaccine while using tositumomab. Live vaccines include measles, mumps, rubella (MMR), Bacillus Calmette-Guérin (BCG), oral polio, rotavirus, smallpox, typhoid, yellow fever, varicella (chickenpox), H1N1 influenza, and nasal flu vaccine. Ask your doctor how long after your treatment you should wait before receiving any vaccines.

Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.

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Avoid handling any of your body fluids without wearing latex rubber gloves. If another person is handling your fluids (vomit, stools, or urine), they should wear gloves, eye protection, and a mask to cover the nose and mouth.

When cleaning any spills of bodily fluid, use only disposable cleaning cloths that can be flushed down a toilet. Ask your doctor or health department how to dispose of any bodily fluid spills that cannot be flushed down a toilet.

To protect others from exposure to the radioactive matter in your body, try to stay at least 6 feet away from other people, especially children or pregnant women. Follow these steps for several days after your tositumomab treatment ends:

  • Avoid crowds and public places.
  • Avoid traveling on long trips.
  • Do not share a bed or bathroom with another person.
  • Sit on the toilet while urinating and flush 3 times with the lid down after use.
  • Always wash your hands after using the bathroom.
  • Do not share a towel, wash cloth, or toothbrush with another person.
  • Do not share drinking glasses, plates, or silverware.
  • Wait at least 1 week before washing any of the clothing and bed or bath linens you have used during the week after your treatment. Keep these items separate from the laundry of other people in your home.
  • Wash your clothing and other items separately from other laundry in your home.

What are the possible side effects of tositumomab?

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Some people receiving a tositumomab injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, nauseated, light-headed, sweaty, or short of breath, or if you have fever or chills during the injection.

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Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

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Call your doctor at once if you have a serious side effect such as:

  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • fever, chills, sore throat, body aches, flu symptoms;
  • blood in your urine or stools, coughing up blood or vomit that looks like coffee grounds; or
  • stabbing chest pain, wheezing, cough with yellow or green mucus; feeling short of breath.

Less serious side effects may include:

  • decreased energy, feeling weak or irritable;
  • weight gain;
  • headache, joint or muscle pain;
  • increased thirst and hot, dry skin;
  • nausea, vomiting, diarrhea, stomach pain, loss of appetite;
  • mild itching or skin rash;
  • runny or stuffy nose; or
  • pain, itching, swelling, or redness around the IV needle.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect tositumomab?

Before receiving tositumomab, tell your doctor if you are using any type of blood thinner or medication used to prevent blood clots, such as:

  • aspirin;
  • warfarin (Coumadin, Jantoven);
  • abciximab (ReoPro), anagrelide (Agrylin), cilostazol (Pletal), clopidogrel (Plavix), dipyridamole (Persantine, Aggrenox), eptifibatide (Integrelin), prasugrel (Effient), rivaroxaban (Xarelto), ticlopidine (Ticlid), tirofiban (Aggrastat);
  • argatroban (Acova), dabigatran (Pradaxa), bivalirudin (Angiomax), lepirudin (Refludan);
  • dalteparin (Fragmin), enoxaparin (Lovenox), fondaparinux (Arixtra), tinzaparin (Innohep); or
  • alteplase (Activase), tenecteplase (TNKase), urokinase (Abbokinase).

This list is not complete and other drugs may interact with tositumomab. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your doctor or pharmacist can provide more information about tositumomab.


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.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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