kit for yttrium-90-ibritumomab 3.2 mg/2 mL intravenous

Generic name:
Ibritumomab tiuxetan - injection

Pronunciation
(EYE-bri-TOOM-oh-mab tye-UX-e-tan)

Brand name(s)
Zevalin

Rituximab, a medication that is used along with ibritumomab tiuxetan, may rarely cause serious (sometimes fatal) side effects, including severe breathing problems (such as hypoxia, pulmonary infiltrates, acute respiratory distress syndrome) or heart problems (such as heart attack, irregular heartbeat, low blood pressure). These effects usually occur within 30 minutes to 2 hours of receiving rituximab. The risk of these effects is greater during your first treatment. Get medical help right away if you have any of the following signs: trouble breathing (such as shortness of breath, wheezing), itching, swelling (especially of the throat/lips), severe dizziness, fast/slow/irregular heartbeat, chest pain.

This medication may cause very serious blood disorders (decreased bone marrow function leading to low number of blood cells such as red cells, white cells, and platelets). This effect can cause anemia, decrease your body's ability to fight an infection, or cause your body to bruise or bleed more easily. Tell your doctor right away if you develop any of the following symptoms: signs of infection (such as sore throat that doesn't go away, fever), easy bruising/bleeding, unusual tiredness, fast/pounding heartbeat.

Rarely, serious (sometimes fatal) skin reactions (such as Stevens-Johnson syndrome) have occurred in patients receiving this treatment program. These reactions can occur during treatment or days to months after treatment is finished. Get medical help right away if you develop a rash or pain/swelling of the mouth/tongue/throat/eyes. If you have previously had a severe skin reaction due to ibritumomab tiuxetan or the other medication(s) used in the treatment program (such as rituximab, yttrium), do not start this treatment program again. Consult your doctor or pharmacist for more details.

This medication is combined with a certain radioactive substance (Yttrium-90) and used along with rituximab to treat a certain type of cancer (B-cell non-Hodgkin's lymphoma) in patients whose cancer has returned or has not responded to other treatments. Ibritumomab tiuxetan and rituximab are known as monoclonal antibodies. They work by killing certain blood and cancer cells from your immune system (B cells). Yttrium-90 helps kill the cancer cells.

This medication is given by injection into a vein by a health care professional. The dosage is based on your medical condition, weight, and response to treatment.

See also Warning section.

Nausea, vomiting, diarrhea, abdominal/stomach pain, cough, dizziness, headache, flushing, or loss of appetite may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including:

• pain/swelling at injection site
• swelling ankles/feet
• mental/mood changes (such as anxiety)
• black stools
• vomit that looks like coffee grounds
• vaginal bleeding

Get medical help right away if you have any very serious side effects, including:

• weakness on one side of the body
• vision problems
• confusion
• trouble speaking

This medication has rarely caused other types of cancer (including myelodysplastic syndrome-MDS, acute myelogenous leukemia-AML). This condition can lead to very serious blood disorders. See also Warning section for symptoms.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to other medications in the treatment plan (rituximab, Yttrium-90); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• blood/bone marrow disorders (such as neutropenia, thrombocytopenia)
• recent/current infections

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your health care professional that you are using ibritumomab tiuxetan before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

Ibritumomab tiuxetan can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

To lower your risk of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

This medication is made from human blood. Even though the blood is carefully tested, and this medication goes through a special manufacturing process, there is an extremely small chance that you may get infections from the medication (for example, viruses such as hepatitis). Consult your doctor or pharmacist for more information.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using ibritumomab tiuxetan. Ibritumomab tiuxetan may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Men and women using this medication should ask about reliable forms of birth control during treatment and for 12 months after the last dose. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this medication and for 6 months after the last dose. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• drugs that affect the immune system (for example, azathioprine, cyclosporine, corticosteroids such as prednisone)
• other drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, NSAIDs such as ibuprofen/naproxen, "blood thinners" such as warfarin/dabigatran)

Aspirin can increase the risk of bleeding when used with this medication. However, if your doctor has told you to take low-dose aspirin to prevent heart attack or stroke (usually 81-162 milligrams a day), you should keep taking the aspirin unless your doctor tells you not to. Ask your doctor or pharmacist for more details.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: signs of infection (such as sore throat that doesn't go away, fever), easy bruising/bleeding, unusual tiredness, fast/pounding heartbeat.

Lab and/or medical tests (such as complete blood count, platelets, blood pressure) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Not applicable. This medication is given in a clinic and will not be stored at home.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.