The originating document has been archived. We cannot confirm the completeness, accuracy and currency of the content.
Generic Name: ibritumomab tiuxetan with indium-111 (EYE-bri-TOOM-oh-mab tye-UX-e-tan/IN-dee-um)
Brand Name: In-111 Zevalin
Rituximab, a medicine used along with In-111 Zevalin, may cause serious, sometimes fatal side effects, such as difficulty breathing, lung problems, heart attack, irregular heartbeats, or shock. If these side effects occur, they usually occur with the first infusion within 30 minutes to 2 hours. Seek immediate medical attention if you develop trouble breathing, swelling, dizziness, lightheadedness, fainting, irregular heartbeat, chest pain, numbness of an arm or leg, sudden severe headache or vomiting, or sudden vision changes.
In-111 Zevalin causes severe and prolonged blood problems in most patients. Patients who have certain bone marrow problems should not use In-111 Zevalin. 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 In-111 Zevalin. If you experience red, swollen, blistered, or peeling skin, contact your doctor immediately.
In-111 Zevalin is used for:
Treating non-Hodgkin lymphoma. 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 In-111 Zevalin binds to, which helps to reduce the number of abnormal cells involved in non-Hodgkin lymphoma.
Do NOT use In-111 Zevalin if:
- you are allergic to any ingredient in In-111 Zevalin, 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 In-111 Zevalin:
Some medical conditions may interact with In-111 Zevalin. 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 In-111 Zevalin. 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 because they may increase the risk of bleeding when used with In-111 Zevalin
This may not be a complete list of all interactions that may occur. Ask your health care provider if In-111 Zevalin 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 In-111 Zevalin:
Use In-111 Zevalin as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- In-111 Zevalin 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 In-111 Zevalin 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.
- Do not use In-111 Zevalin 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 In-111 Zevalin 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 In-111 Zevalin.
Important safety information:
- In-111 Zevalin may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use In-111 Zevalin with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- In-111 Zevalin 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.
- In-111 Zevalin 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.
- In-111 Zevalin may increase the risk of certain blood cancers (eg, acute myelogenous leukemia) or blood problems (eg, myelodysplastic syndrome). Talk with your doctor if you have questions about your risk while using In-111 Zevalin.
- Your doctor may prescribe medicines to be taken 30 minutes before In-111 Zevalin 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 In-111 Zevalin until your doctor tells you to do so.
- Do not receive a live vaccine (eg, measles, mumps) while you are taking In-111 Zevalin. Talk with your doctor before you receive any vaccine.
- Carry an ID card at all times that says you take this medication.
- In-111 Zevalin contains albumin, which comes from human blood. There is a very rare risk of getting a viral disease or a central nervous system disease called Creutzfeldt-Jakob disease from products with albumin. No cases of these problems have been found in patients who have used In-111 Zevalin.
- 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.
- In-111 Zevalin should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
- Men receiving In-111 Zevalin should use reliable methods of birth control while taking In-111 Zevalin and for at least 1 year after taking In-111 Zevalin. Consult your doctor for more details.
- Women of childbearing age receiving In-111 Zevalin should use reliable methods of birth control while taking In-111 Zevalin and for at least 1 year after taking In-111 Zevalin. Consult your doctor for more details.
- PREGNANCY and BREAST-FEEDING: In-111 Zevalin has been shown to cause harm to the fetus. If you think that you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using In-111 Zevalin while you are pregnant. It is not known if this medicine is found in breast milk. Do not breast-feed while taking In-111 Zevalin.
Possible side effects of In-111 Zevalin:
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:
Anxiety; constipation; diarrhea; dizziness; flushing; headache; indigestion; joint or muscle pain; loss of appetite; nausea; runny nose; stomach pain or upset; sweating; throat irritation; trouble sleeping; vomiting; weakness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); back pain; black, bloody, or dark stools; chest pain; cough; fainting; fast or irregular heartbeat; lightheadedness; numbness of an arm or leg; pain, burning, swelling, or redness at the injection site; persistent or severe diarrhea; red, swollen, blistered, or peeling skin; severe stomach pain or swelling; severe tiredness or weakness; shortness of breath; signs of infection (fever, chills, persistent sore throat); sudden, severe or persistent headache; swelling of the hands, feet, or legs; unusual bruising or bleeding; unusual vaginal bleeding; vision problems; vomit that looks like coffee grounds; yellowing of the eyes or skin.
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 blood problems.Proper storage of In-111 Zevalin:
In-111 Zevalin is usually handled and stored by a health care provider. If you are using In-111 Zevalin at home, store In-111 Zevalin as directed by your pharmacist or health care provider. Keep In-111 Zevalin out of the reach of children and away from pets.
- If you have any questions about In-111 Zevalin, please talk with your doctor, pharmacist, or other health care provider.
- In-111 Zevalin 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 In-111 Zevalin 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 In-111 Zevalin. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to In-111 Zevalin. 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 In-111 Zevalin.