This medication will cause very serious blood disorders (decreased bone marrow function leading to low number of blood cells such as white cells, red cells, and platelets). This effect can decrease your body's ability to fight an infection, cause anemia, or cause your body to bruise or bleed more easily. Tell your doctor immediately if you develop any of the following symptoms: signs of infection (e.g., fever, persistent sore throat), easy bruising/bleeding, unusual tiredness, fast/pounding heartbeat.

This medication may cause a very serious (infrequently fatal) allergic reaction or breathing problems. In most cases, these reactions occurred while the medication was being given or within 24 hours, and the symptoms usually went away afterward. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction or breathing problem, including rash, itching, swelling, severe dizziness, shortness of breath, or trouble breathing.

This medication may also cause very serious (possibly fatal) liver disease. Tell your doctor immediately if you develop symptoms of liver disease, including persistent nausea/vomiting, yellowing skin/eyes, sudden weight gain, or severe stomach/abdominal pain.

This medication is used to treat a certain type of leukemia (acute myeloid leukemia-AML). It is recommended for use in patients whose AML has returned for the first time and who are 60 years or older and cannot use other forms of cancer chemotherapy. This medication works by stopping the growth of cancer cells.

This medication is given by injection into a vein by a health care professional. Follow all instructions for proper mixing and dilution with the correct IV fluid. The medication may appear cloudy, which is normal. Before using, check this product visually for large/unusual particles or discoloration. If either is present, do not use the liquid. Do not mix gemtuzumab ozogamicin with other medications in the same IV bag or give together with other medications through the same IV line. Protect the medication from light while it is prepared and given. If you have any questions about the preparation or use of this medication, consult your pharmacist.

Dosage is based on your body size. This medication is usually given over 2 hours with another dose given 14 days later for a total of 2 doses. You will be given other medications (e.g., acetaminophen, diphenhydramine) before the infusion to help prevent side effects.

To get the most benefit from this medication, do not miss any doses. To help you remember, mark the days on the calendar when you need to receive the medication.

See also Warning section.

Fever, chills, dizziness, headache, nausea, vomiting, or pain/swelling at injection site may occur during or after the infusion. Tell your doctor or pharmacist promptly if any of these effects occur, persist, or worsen. You may be given additional medications to help control these symptoms. Mouth sores, a mild rash, constipation, or diarrhea may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Many people using this medication may have serious side effects. However, your doctor has prescribed this drug because he or she 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 immediately if any of these unlikely but serious side effects occur: increased thirst/urination, change in the amount of urine, muscle spasm/weakness, seizures, fast/irregular heartbeat, black/bloody stools.

Seek immediate medical attention if any of these rare but very serious side effects occur: slurred speech, weakness on one side of the body, confusion, pain/redness/swelling of arms or legs.

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.

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 receiving this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, lung disease, other blood/bone marrow disorders (e.g., increased white blood cell count), bone marrow transplant, recent/current infections.

Before having surgery, tell your doctor or dentist that you are using this medication.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose.

Wash your hands well to prevent the spread of infections.

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 not recommended for use during pregnancy. Consult your doctor for more details. If you become pregnant or think you may be pregnant, tell your doctor immediately.

It is not known whether this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: other cancer chemotherapy drugs.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

Laboratory and/or medical tests (e.g., complete blood count, uric acid levels, blood electrolyte levels, liver function, blood pressure) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor to establish a new dosing schedule.

This product must be protected from light at all times. Refrigerate the vials of powder between 36-46 degrees F (2-8 degrees C). The mixed medication may be stored at room temperature between 59-86 degrees F (15-30 degrees C) or in the refrigerator between 36-46 degrees F (2-8 degrees C) for up to 2 hours before diluting. The diluted medication may be stored at room temperature between 59-86 degrees F (15-30 degrees C) for up to 16 hours before use. Each vial should be used only once. Throw away any unused portion. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.