Ibritumomab Tiuxetan with Indium-111


|Ibritumomab Tiuxetan with Indium-111

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Ibritumomab Tiuxetan with Indium-111

Generic Name: Ibritumomab Tiuxetan with Indium-111 (ib-rih-TYOO-moe-mab tie-UX-ih-tan)
Brand Name: In-111 Zevalin

Rituximab, a medicine used along with Ibritumomab Tiuxetan with Indium-111 , may cause serious, sometimes fatal side effects, such as difficulty breathing, lung problems, heart attack, irregular heartbeats, or shock. If these side effects are going to occur, they usually occur with the first infusion within 30 minutes to 2 hours. Seek immediate medical attention if you develop severe trouble breathing, swelling, dizziness, lightheadedness, irregular heartbeat, or chest pain.

Ibritumomab Tiuxetan with Indium-111 causes severe and prolonged blood problems in most patients. Patients who have certain bone marrow problems should not use Ibritumomab Tiuxetan with Indium-111 . If you develop unusual bruising or bleeding, fever, chills, sore throat, or other signs of infection, contact your doctor immediately.

Severe and sometimes fatal skin problems have been reported with use of Ibritumomab Tiuxetan with Indium-111 . If you experience red, swollen, blistered, or peeling skin, contact your doctor immediately.

Ibritumomab Tiuxetan with Indium-111 is used for:

Treating non-Hodgkin lymphoma that has redeveloped or has not responded to other medicines. It is used in combination with rituximab and 2 radioactive materials (In-111 and Y-90).

Ibritumomab is a monoclonal antibody protein. It works by binding to the cells that are involved in non-Hodgkin lymphoma. It is used along with 2 different radioactive materials. The first radioactive material (In-111) is attached to confirm that the cells are being reached. The second radioactive material (Y-90) is attached and damages the cells Ibritumomab Tiuxetan with Indium-111 binds to, which helps to reduce the number of abnormal cells involved in non-Hodgkin lymphoma.

Do NOT use Ibritumomab Tiuxetan with Indium-111 if:

  • you are allergic to any ingredient in Ibritumomab Tiuxetan with Indium-111 , murine (mice, rats) proteins, or indium
  • you have bone marrow depression

Contact your doctor or health care provider right away if any of these apply to you.

Before using Ibritumomab Tiuxetan with Indium-111 :

Some medical conditions may interact with Ibritumomab Tiuxetan with Indium-111 . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are of childbearing age, 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
  • if you have blood disorders, such as low red blood cell counts, low white blood cell counts, or low platelet counts, or failed stem cell collection

Some MEDICINES MAY INTERACT with Ibritumomab Tiuxetan with Indium-111 . Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Aspirin, clopidogrel, warfarin, and other medicines that thin the blood may increase the risk of bleeding when used with Ibritumomab Tiuxetan with Indium-111

This may not be a complete list of all interactions that may occur. Ask your health care provider if Ibritumomab Tiuxetan with Indium-111 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 Ibritumomab Tiuxetan with Indium-111 :

Use Ibritumomab Tiuxetan with Indium-111 as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Ibritumomab Tiuxetan with Indium-111 is administered as an injection at your doctor"s office, hospital, or clinic.
  • Ibritumomab is not a radioactive chemical by itself. There is no risk of radioactive exposure with this medication kit until it is combined with In-111 or Y-90; all radioactive handling precautions should be followed at that time. The radioactive medicine will be added to Ibritumomab Tiuxetan with Indium-111 by a properly trained medical professional.
  • After being given another medicine (rituximab), ibritumomab with In-111 will be injected into a vein as prescribed by the doctor. Generally, 7 to 9 days later, another rituximab dose is given, followed by ibritumomab in combination with Y-90. The dosage is based on your medical condition, response to therapy, and an established dosing guideline. Consult your doctor for details.
  • If Ibritumomab Tiuxetan with Indium-111 contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
  • Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.
  • If you miss a dose of Ibritumomab Tiuxetan with Indium-111 or your dose is interrupted, contact your doctor immediately to establish a new dosing schedule.

Ask your health care provider any questions you may have about how to use Ibritumomab Tiuxetan with Indium-111 .

Important safety information:

  • Ibritumomab Tiuxetan with Indium-111 may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Ibritumomab Tiuxetan with Indium-111 . Using Ibritumomab Tiuxetan with Indium-111 alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
  • Ibritumomab Tiuxetan with Indium-111 may reduce the number of clot-forming cells (platelets) in your blood. To prevent bleeding, avoid situations in which bruising or injury may occur. Report any unusual bleeding, bruising, blood in stools, or dark, tarry stools to your doctor.
  • Ibritumomab Tiuxetan with Indium-111 may lower your body"s ability to fight infection. Prevent infection by avoiding contact with people with colds or other infections. Notify your doctor of any signs of infection, including fever, sore throat, rash, or chills.
  • Your doctor may prescribe medicines to be taken 30 minutes before Ibritumomab Tiuxetan with Indium-111 is given. These medicines may decrease the risk and/or severity of allergic reactions and some side effects. If you experience difficulty breathing; tightness of the chest; or swelling of the eyelids, face, or lips; or if you develop a rash or hives, tell your doctor immediately. Do not take any more doses of Ibritumomab Tiuxetan with Indium-111 until your doctor tells you to do so.
  • Check with your doctor before having vaccinations while you are using Ibritumomab Tiuxetan with Indium-111 .
  • Carry an identification card at all times that says you are taking this medication.
  • LAB TESTS, including complete blood cell and platelet counts, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
  • Ibritumomab Tiuxetan with Indium-111 is not recommended for use in CHILDREN. Safety and effectiveness have not been confirmed.
  • Men receiving Ibritumomab Tiuxetan with Indium-111 should use reliable methods of birth control while, and for at least 1 year after, taking Ibritumomab Tiuxetan with Indium-111 . Consult your doctor for more details.
  • Women of childbearing age receiving Ibritumomab Tiuxetan with Indium-111 should use reliable methods of birth control while, and for at least 1 year after, taking Ibritumomab Tiuxetan with Indium-111 . Consult your doctor for more details.
  • PREGNANCY and BREAST-FEEDING: Ibritumomab Tiuxetan with Indium-111 has been shown to cause harm to the fetus. If you think that you may be pregnant, contact your doctor immediately. It is unknown if Ibritumomab Tiuxetan with Indium-111 is excreted in breast milk. Do not breast-feed while taking Ibritumomab Tiuxetan with Indium-111 .

Possible side effects of Ibritumomab Tiuxetan with Indium-111 :

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:

Anxiety; back pain; bloated stomach; bruising; constipation; diarrhea; dizziness; flu-like symptoms (eg, cough, chills, muscle aches); flushing; headache; increased cough; indigestion; itching; joint pain; loss of appetite; nausea; nosebleed; pain; runny nose; sleeplessness; sore throat; stomach pain; stomach upset; sweating; swelling of the hands and feet; throat irritation; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, bloody, or dark stools; coffee-ground vomit; easy bruising or bleeding; hoarseness; infection (fever, chills, sore throat); interrupted breathing; loss of appetite; mental or mood changes; one-sided weakness; pain (eg, stomach, muscle, back, or joint); persistent sore throat; red, swollen, blistered, or peeling skin; secondary cancer; stroke; swelling of the hands, feet, face; swelling of the lungs; unusual tiredness; unusual weight loss; unusually fast heartbeat; vision problems; weakness.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include blood problems.

Proper storage of Ibritumomab Tiuxetan with Indium-111 :

Ibritumomab Tiuxetan with Indium-111 is usually handled and stored by a health care provider. Keep Ibritumomab Tiuxetan with Indium-111 out of the reach of children and away from pets.

General information:

  • If you have any questions about Ibritumomab Tiuxetan with Indium-111 , please talk with your doctor, pharmacist, or other health care provider.
  • Ibritumomab Tiuxetan with Indium-111 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.

This information is a summary only. It does not contain all information about Ibritumomab Tiuxetan with Indium-111 . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: November 1, 2006
Database Edition
Copyright © 2006 Wolters Kluwer Health, Inc.

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