Gemtuzumab Ozogamicin, Injection

What are other names for this medicine?

Type of medicine: antineoplastic (anticancer); chemotherapy

Generic and brand names: gemtuzumab ozogamicin, injection; Mylotarg

What is this medicine used for?

This medicine is given by IV infusion (slow drip through a needle into a large vein) to treat acute myeloid leukemia (AML). It may be used for other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• an allergic reaction to any medicine
• liver or kidney disease

This medicine may make you sterile (unable to have children) whether you are a man or a woman. If you plan to have children someday, talk with your healthcare provider before you start treatment.

Tell your healthcare provider if you have any signs of infection such as cough, shortness of breath, sore throat, fever, chills, or mouth sores before or after starting this medicine.

Females of childbearing age: This medicine is not usually given to pregnant women because it can harm the baby. If you are pregnant, tell your healthcare provider. Do not become pregnant while you are receiving this medicine because it may harm the baby. Talk to your healthcare provider if you need birth control. Contact your healthcare provider at the first sign of pregnancy. Do not breast feed while receiving this medicine.

How do I use it?

This medicine is given by IV infusion (slow drip through a needle into a large vein) by healthcare providers experienced in providing chemotherapy. You will receive this medicine in facilities where you can be carefully monitored.

You may need several treatments with this medicine. Blood and bone marrow tests are used to determine how many courses of treatment you will need.

What should I watch out for?

You will need to have blood and bone marrow tests regularly to see how this medicine affects you. Keep all appointments for tests. You will be monitored closely while you are receiving this medicine, so healthcare personnel can see and treat any side effects you may have.

You may get infections more easily when you are taking this medicine. Stay away from people with colds, flu, or other infections. Also, do not have any vaccines without getting your healthcare provider's approval first.

This medicine may cause bone marrow problems. Contact your healthcare provider right away if you develop a fever, sore throat, bleeding, bruising, chest pain, irregular heartbeat, severe abdominal pain, or any sign of infection.

While this medicine is infusing, report any symptoms of chest tightness, back pain, or flushing. The infusion can be stopped and restarted at a slower rate to prevent these problems.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (report these to your healthcare provider right away): Redness, swelling, or pain at the injection site; rapid or slow heart rate; muscle twitches or weakness; chest pain or shortness of breath that continues; fever; mouth sores; unusual bleeding or bruising; swelling in your legs and feet, or any unexplained swelling; dark urine; yellowing of the skin and eyes; black, bloody, or tarry stools.

Other: Loss of appetite, nausea, vomiting, trouble sleeping, hair loss, headache, diarrhea, constipation, heavy sweating, stuffy or runny nose, facial flushing.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• alcohol
• carbamazepine (Tegretol, Carbatrol)
• clozapine (Clozaril)
• colchicine
• interferon alfa (Intron-A, Roferon-A)
• medicines to treat cancer such as cyclophosphamide (Cytoxan, Neosar), busulfan (Myleran), and trastuzumab (Herceptin)
• methotrexate (Folex, Rheumatrex, Trexall)
• vaccines
• zidovudine (Retrovir)

Do not drink alcohol while you are being treated with this medicine.

Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.

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