Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. Bexxar

Descriptions


Tositumomab and iodine I 131 tositumomab combination regimen is used to treat patients with CD20-positive, relapsed or refractory non-Hodgkin's lymphoma. It is also given to patients with non-Hodgkin's lymphoma who already have received rituximab.

This medicine is to be given only by or under the immediate supervision of your doctor.

The tositumomab and iodine I 131 tositumomab combination regimen will be withdrawn from the United States market on February 20, 2014.

This product is available in the following dosage forms:

  • Solution

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of the Bexxar® regimen in the pediatric population. Safety and efficacy have not been established.

Geriatric

Although appropriate studies on the relationship of age to the effects of the Bexxar® regimen have not been performed in the geriatric population, no geriatric-specific problems have been documented to date.

Pregnancy

Information about this tositumomab-intravenous-route
Pregnancy Category Explanation
All Trimesters D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breastfeeding

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Breastfeeding

Breastfeeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Anemia (low number of red blood cells) or
  • Hypothyroidism (underactive thyroid) or
  • Leukemia or
  • Myelodysplastic syndrome (MDS) or
  • Neutropenia (low number of white blood cells) or
  • Thrombocytopenia (low number of platelets)—Use with caution. May make these conditions worse.
  • Kidney disease or
  • Urinary tract blockage—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use

Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

A doctor will give you this medicine in a hospital or cancer treatment center. This medicine is given through a needle placed in one of your veins.

Bexxar® therapeutic regimen consists of 2 separate components (tositumomab and iodine I 131 tositumomab) which are given in 2 separate steps 7 to 14 days apart. You may also receive medicines (e.g., acetaminophen, diphenhydramine) to help prevent possible allergic reactions to the injection.

Precautions

It is very important that your doctor check you closely while you are receiving this medicine. This is to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. You should not become pregnant while you are receiving this medicine and for 12 months after stopping it. Male patients should also use effective contraception to prevent pregnancy while receiving this medicine and for 12 months after stopping it. Tell your doctor right away if you become pregnant while using the medicine.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, fever or chills, lightheadedness or dizziness, nausea, trouble breathing, or any swelling of your hands, face, mouth, or throat during treatment or within 48 hours receiving this medicine.

Tositumomab and iodine I 131 tositumomab regimen can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

  • Avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
  • Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin.
  • Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
  • Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
  • Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
  • Avoid sports or other situations where bruising or injury could occur.

While using this medicine, you may be exposed to radiation. Talk with your doctor if you have concerns about this.

This medicine may increase your risk for certain types of cancer or thyroid problems. Talk with your doctor about these risks.

While you are being treated with tositumomab and iodine I 131 tositumomab regimen, and after you stop treatment with it, do not have any immunizations (live vaccines) without your doctor's approval. Tositumomab and iodine I 131 tositumomab may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent.

If you plan to have children, talk with your doctor before using this medicine. Some men and women using this medicine have become infertile (unable to have children).

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

  1. Bleeding gums
  2. bloating or swelling of the face, arms, hands, lower legs, or feet
  3. blurred vision
  4. bone pain
  5. chest pain
  6. chills
  7. confusion
  8. constipation
  9. cough
  10. coughing up blood
  11. depressed mood
  12. difficulty with breathing
  13. difficulty with swallowing
  14. dizziness
  15. dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  16. dry skin and hair
  17. fast heartbeat
  18. feeling cold
  19. fever or chills
  20. hair loss
  21. headache
  22. hives
  23. hoarseness or husky voice
  24. increased menstrual flow or vaginal bleeding
  25. itching
  26. large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  27. lower back or side pain
  28. muscle cramps and stiffness
  29. noisy breathing
  30. nosebleeds
  31. painful or difficult urination
  32. pale skin
  33. paralysis
  34. pinpoint red spots on the skin
  35. prolonged bleeding from cuts
  36. puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  37. rapid weight gain
  38. red or black, tarry stools
  39. red or dark brown urine
  40. shortness of breath
  41. skin rash
  42. slowed heartbeat
  43. sore throat
  44. sores, ulcers, or white spots on the lips or in the mouth
  45. sweating
  46. swollen glands
  47. tightness in the chest
  48. tingling of the hands or feet
  49. troubled breathing with exertion
  50. unusual bleeding or bruising
  51. unusual tiredness or weakness
  52. unusual weight gain or loss
  53. wheezing

Less common

  1. Feeling of warmth or heat
  2. flushing or redness of the skin, especially on the face and neck

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  1. Acid or sour stomach
  2. back pain
  3. belching
  4. body aches or pain
  5. congestion
  6. diarrhea or increased bowel movements
  7. difficult or labored breathing
  8. difficulty with moving
  9. dryness or soreness of the throat
  10. heartburn
  11. indigestion
  12. itching skin
  13. joint pain
  14. lack or loss of strength
  15. loose or liquid stools
  16. loss of appetite
  17. muscle aches or pains
  18. nausea or feeling of upset stomach or feeling like you may vomit
  19. neck pain
  20. runny nose
  21. stomach discomfort, upset, or pain
  22. sudden sweating
  23. swelling of the hands, ankles, feet, or lower legs
  24. swollen joints
  25. tender, swollen glands in the neck
  26. trouble with swallowing
  27. voice changes
  28. vomiting
  29. weight loss

Less common

  1. Sleepiness or unusual drowsiness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.