Gemtuzumab Ozogamicin (jem-TOOZ-oo-mab oh-zoe-ga-MYE-sin)

Treats acute myeloid leukemia (AML) in patients 60 years of age and older who have already been treated with other cancer medicines that did not work well. Products containing gemtuzumab were withdrawn from the U.S. market by Pfizer Inc. on October 15, 2010.

Brand Name(s):

Mylotarg

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine.
• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given through a needle placed in one of your veins.
• This medicine is given slowly, so the needle will remain in place for about 2 hours. This medicine is given as 2 doses, usually 14 days apart.
• You may need to use other medicines to help prevent some of the unwanted effects from this medicine, such as allergic reactions. Take all medicines exactly as your doctor has prescribed.
• Drink extra fluids so you will pass more urine while you are using this medicine. This will keep your kidneys working well and help prevent kidney problems.

If a dose is missed:

• This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.
• Make sure your doctor knows if you are breastfeeding, or if you have liver disease, lung disease, low blood pressure, or any type of infection. Tell your doctor if you have had a stem-cell transplant.
• This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.
• This medicine may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor or nurse right away if you have blue lips, fingernails, or skin; difficult or fast breathing; dizziness, fainting, or lightheadedness; fever or chills; rash; trouble breathing or swallowing; or any swelling of your hands, face, or mouth after receiving this medicine.
• Check with your doctor immediately if you have any symptoms of liver problems including skin and eyes turning yellow, dark brown-colored urine, right-sided abdominal or stomach pain, fever, or severe tiredness.
• This medicine may cause a serious type of reaction called tumor lysis syndrome. Your doctor may give you a medicine to help prevent this. Call your doctor right away if you have a decrease or change in urine amount; joint pain, stiffness, or swelling; lower back, side, or stomach pain; a rapid weight gain; swelling of the feet or lower legs; or unusual tiredness or weakness.
• Your doctor will need to check your blood at regular visits while you are using this medicine. Be sure to keep all appointments.
• Cancer medicines can cause nausea and/or vomiting in most people, sometimes even after receiving medicines to prevent it. Ask your doctor or nurse about other ways to control these side effects.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing.
• Chest pain or shortness of breath.
• Dark-colored urine or pale stools.
• Decrease in how much or how often you urinate.
• Dry mouth, increased thirst, or muscle cramps.
• Fast or slow, pounding, or uneven heartbeat.
• Fever, chills, cough, sore throat, and body aches.
• Increased hunger or thirst.
• Large, flat, blue, or purplish patches in the skin.
• Lightheadedness or fainting.
• Nausea, vomiting, loss of appetite, or pain in your upper stomach.
• Nosebleeds.
• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed.
• Rapid weight gain.
• Sores or white patches on the lips, mouth, or throat.
• Sudden and severe pain in the upper stomach.
• Swelling in your hands, ankles, or feet.
• Unusual bleeding, bruising, or weakness.
• Yellowing of your skin or the whites of your eyes.

If you notice these less serious side effects, talk with your doctor:

• Anxiety or depression.
• Back pain.
• Constipation, diarrhea, or upset stomach.
• Headache.
• Joint or muscle pain.
• Rash or itching skin.
• Stuffy or runny nose.
• Trouble sleeping.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088