The originating document has been archived. We cannot confirm the completeness, accuracy and currency of the content.
Bexxar 131 Iodine
Generic Name: iodine i 131/tositumomab (EYE-oh-dine/TOE-sih-too-MOE-mab)
Brand Name: Bexxar 131 Iodine
Bexxar 131 Iodine may cause serious allergic reactions during or within 48 hours of receiving Bexxar 131 Iodine. Seek immediate medical attention if you experience rash; hives; itching; difficulty breathing; dizziness; unusual nausea or sweating; tightness in the chest; or swelling of the mouth, face, lips, or tongue.
Bexxar 131 Iodine may cause serious (possibly life-threatening) reductions in the number of white blood cells and platelets your body produces. This effect may last for an extended length of time. Additional treatment may be needed to manage this effect. Serious infections or bleeding could occur as a result of low blood cell levels. Contact your doctor immediately if you experience fever, chills, persistent sore throat, or any other sign of infection, or unusual bruising or bleeding.
Bexxar 131 Iodine is used for:
Treating certain forms of non-Hodgkin lymphoma in patients who have not responded to other therapy.
Bexxar 131 Iodine is a radioactive monoclonal antibody protein. It works by killing cancer cells.
Do NOT use Bexxar 131 Iodine if:
- you are allergic to any ingredient in Bexxar 131 Iodine
- you have severe anemia, low white blood cell counts (neutropenia), or low blood platelet counts (thrombocytopenia)
- you are unable to take a thyroid blocker (eg, methimazole)
Contact your doctor or health care provider right away if any of these apply to you.
Before using Bexxar 131 Iodine:
Some medical conditions may interact with Bexxar 131 Iodine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances (eg, mouse proteins)
- if you have an infection, thyroid problems, kidney problems, or urinary blockage
- if you are scheduled to receive a vaccine
Some MEDICINES MAY INTERACT with Bexxar 131 Iodine. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Medicines that decrease blood clotting (eg, aspirin, clopidogrel, ibuprofen, warfarin) and medicines that affect the immune system (eg, azathioprine, corticosteroids, cyclosporine) because serious side effects, such as risk of bleeding or infections, may be increased
This may not be a complete list of all interactions that may occur. Ask your health care provider if Bexxar 131 Iodine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Bexxar 131 Iodine:
Use Bexxar 131 Iodine as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Bexxar 131 Iodine is usually administered as an injection at your doctor's office, hospital, or clinic. Ask your doctor any question that you may have about Bexxar 131 Iodine.
- To help prevent an allergic reaction, you should receive certain other medicines (acetaminophen, diphenhydramine) before you receive your dose of Bexxar 131 Iodine. Discuss any questions or concerns with your doctor.
- Do not use Bexxar 131 Iodine if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
- Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
- If you miss a dose of Bexxar 131 Iodine, contact your doctor right away.
Ask your health care provider any questions you may have about how to use Bexxar 131 Iodine.
Important safety information:
- Bexxar 131 Iodine may cause dizziness or drowsiness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Bexxar 131 Iodine. Using Bexxar 131 Iodine alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
- Bexxar 131 Iodine may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
- Bexxar 131 Iodine may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
- Do not receive a live vaccine (eg, measles, mumps, oral polio) while you are taking Bexxar 131 Iodine. Talk with your doctor before you receive any vaccine.
- A serious bone marrow problem (myelodysplastic syndrome [MDS]) and secondary cancer have been reported with Bexxar 131 Iodine. Discuss the benefits and risks of using Bexxar 131 Iodine with your doctor.
- After receiving Bexxar 131 Iodine, the radioactive part of the dose will be in your body for several days. Follow all instructions you are given to minimize the exposure of others around you to this radioactivity.
- Tell your doctor or dentist that you take Bexxar 131 Iodine before you receive any medical or dental care, emergency care, or surgery.
- Bexxar 131 Iodine may reduce the levels of thyroid hormone your thyroid produces. To prevent low thyroid function, you should also take a thyroid blocker medicine (eg, methimazole) while receiving Bexxar 131 Iodine. Take the thyroid blocker medicine as directed by your doctor. Discuss any questions or concerns with your doctor.
- Some patients may develop an immune response called human anti-murine antibody (HAMA) after using Bexxar 131 Iodine. This antibody may interfere with certain lab test results. Be sure all of your doctors and laboratory personnel know that you are being treated, or have been treated, with Bexxar 131 Iodine.
- Both men and women capable of having children who receive Bexxar 131 Iodine should use effective birth control (eg, condoms) while receiving Bexxar 131 Iodine and for at least 1 year after receiving it. Contact your doctor if you have questions about effective birth control.
- Bexxar 131 Iodine may cause temporary decreased fertility in men and women. Discuss any questions or concerns with your doctor.
- LAB TESTS, including complete blood cell counts and thyroid function tests, will be performed while you use Bexxar 131 Iodine and following treatment. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Bexxar 131 Iodine should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Bexxar 131 Iodine may cause harm to the fetus, including low thyroid function. Avoid becoming pregnant while you are taking it. If you become pregnant while taking Bexxar 131 Iodine or after you have recently received it, contact your doctor. You will need to discuss the benefits and risks of using Bexxar 131 Iodine while you are pregnant. Bexxar 131 Iodine is most likely excreted in breast milk. Do not breast-feed while receiving Bexxar 131 Iodine or after you have recently received it.
Possible side effects of Bexxar 131 Iodine:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Back pain; constipation; diarrhea; dizziness; drowsiness; headache; muscle or joint pain; nausea; neck pain; stomach pain; stomach upset; vomiting; weakness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); chest pain; dark, tarry, or bloody stools; fainting; flushing of the skin; light-headedness; loss of appetite; pale skin; open sore that does not heal; pain, swelling, or redness at the injection site; severe or persistent dizziness or nausea; shortness of breath; swelling of the hands, ankles, or feet; symptoms of infection (eg, fever; chills; persistent cough or sore throat; red, warm, or painful skin; runny nose); unexplained weight loss; unusual bruising or bleeding; unusual lumps or skin growths; unusual sweating; unusual tiredness or weakness; vomit that looks like coffee grounds.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include symptoms of infection (eg, fever; chills; persistent cough or sore throat; red, warm, or painful skin; runny nose); unusual bruising or bleeding; unusual tiredness or weakness.Proper storage of Bexxar 131 Iodine:
Bexxar 131 Iodine is radioactive and must be stored in the lead pot provided. It is usually handled and stored by a health care professional. Keep Bexxar 131 Iodine out of reach of children and away from pets.
- If you have any questions about Bexxar 131 Iodine, please talk with your doctor, pharmacist, or other health care provider.
- Bexxar 131 Iodine is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Bexxar 131 Iodine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Bexxar 131 Iodine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Bexxar 131 Iodine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Bexxar 131 Iodine.