Important Note

The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

IBRITUMOMAB TIUXETAN - INJECTABLE

(ih-brih-TOO-mow-mab tie-ooh-X-eh-tan)

COMMON BRAND NAME(S): Zevalin

WARNING: A medication used along with this product (rituximab) may infrequently cause serious (sometimes fatal) side effects including severe lung problems (e.g., hypoxia, pulmonary infiltrates, ARDS), heart problems (e.g., cardiogenic shock, MI, ventricular fibrillation), and blood disorders (e.g., cytopenias). These effects, if they occur, usually occur within 30 minutes to 2 hours of receiving the drug. Tell your doctor if you have any blood disorders, heart problems, or breathing problems before using this product and seek immediate medical attention if you develop severe trouble breathing, swelling, dizziness/lightheadedness, irregular heartbeat, or chest pain.

Uses

Ibritumomab tiuxetan is a type of protein (monoclonal antibody plus a chelator) used, along with another monoclonal antibody (rituximab) and two radioactive pharmaceuticals (In-111 and Y-90); to treat a certain form of cancer (non-Hodgkin's lymphoma).

How To Use

Follow all instructions for proper handling, mixing, and dilution with the correct IV fluids. If you have any questions regarding the use of this medication, consult the doctor or pharmacist. Ibritumomab is not a radioactive chemical by itself. There is no risk of radioactive exposure with this medication kit until it is combined with the In-111 or Y-90; all radioactive handling precautions should be followed at that time. The radioactive medication will be added to this drug by a properly-trained medical professional. Your doctor may prescribe medications to be taken 30 minutes before this drug is given. These drugs may help decrease the risk and/or severity of allergic reactions and some side effects. After being given another medication (rituximab), this medication will be injected into a vein (IV) over 10 minutes exactly as prescribed by the doctor. Generally, another rituximab dose is given 7 to 9 days later, followed by this medication, given IV over a 10 minute period. The dosage is based on your medical condition, response to therapy, and an established dosing guideline. Consult your doctor for details. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard needles and medical supplies safely. Consult your pharmacist.

Side Effects

Nausea, vomiting, diarrhea, constipation, headache, stomach upset, dizziness, and/or flu-like symptoms (e.g., cough, chills, muscle aches) may occur. If any of these effects persist or worsen, notify your doctor promptly. Tell your doctor immediately if any of these serious side effects occur: easy bruising or bleeding, persistent sore throat or fever, swelling of the hands/feet/face, unusual tiredness and weakness, loss of appetite, unusual weight loss, pain (e.g., stomach, muscle, back, or joint pain). Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes, unusually fast heartbeat, black stools, coffee-ground vomit, one-sided weakness, vision problems. An allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction may include: rash, itching, swelling, trouble breathing. Rarely, this medication may cause certain cancers (e.g., AML). If you notice other effects not listed above, contact your doctor or pharmacist.

Precautions

Tell your doctor your medical history, especially of: blood disorders (e.g., anemia, neutropenia, thrombocytopenia), previous bone marrow therapy (myeloablative), current infections, any allergies. This drug may make you dizzy; use caution engaging in activities requiring alertness such as driving or using machinery. Limit alcoholic beverages. Because this medication can decrease your immune system function, do not have immunizations/vaccinations without the consent of your doctor and avoid contact with people who have recently received live vaccines (e.g., oral polio vaccine). Use caution with sharp objects like safety razors or nail cutters and avoid activities that may increase the chance of getting cut, bruised, or injured. This medication is not recommended for use during pregnancy; it may cause fetal harm. Women of child-bearing age, and men, are recommended to use effective birth control methods during and for up to 1 year after treatment with this drug. Consult your doctor for more details. It is not known whether this drug passes into breast milk. Because of the potential risk to the infant, breast-feeding while using this drug is not recommended.

Drug Interactions

Tell your doctor of all prescription and nonprescription medication you may use, especially: "blood thinners" (e.g., warfarin), drugs that affect the platelets (e.g., aspirin, clopidogrel, ticlopidine, NSAIDs such as ibuprofen), drugs that affect the immune system (e.g., azathioprine, cyclosporine, or corticosteroids such as prednisone). Do not start or stop any medicine without doctor or pharmacist approval.

Overdose

If overdose is suspected, contact your local poison control center or emergency room immediately.

Notes

Laboratory and/or medical tests (e.g., blood counts, radio-imaging tests) will be performed to monitor your progress.

Missed Dose

If you miss a dose or your dose is stopped, contact your doctor immediately to establish a new dosing schedule.

Storage

Store this product kit refrigerated between 36 and 46 degrees F (2 and 8 degrees C) away from light. Do not freeze.

Medical Alert

Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA), or 1-800-668-1507 (Canada).