DrugindexOnline^{2nd edition}

Generic Name: gemtuzumab (gem TOO zoo mab)
Brand Names: Mylotarg

What is Mylotarg (gemtuzumab)?

Gemtuzumab is a cancer (antineoplastic) medication. Gemtuzumab interferes with the growth of cancer cells and slows their growth and spread in the body.

Gemtuzumab is used in the treatment of acute myeloid leukemia, a type of blood cancer.

Gemtuzumab may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Mylotarg (gemtuzumab)?

Gemtuzumab should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents.

Serious side effects have been reported with the use of gemtuzumab including: allergic and infusion reactions (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; black, bloody or tarry stools; fever or chills; or signs of infection); liver problems; lung problems; and others. Talk to your doctor about the possible side effects from treatment with gemtuzumab.

What should I discuss with my healthcare provider before taking Mylotarg (gemtuzumab)?

Do not use gemtuzumab without first talking to your doctor if you have

• any type of infection;

• lung or breathing problems;

• liver disease; or
• kidney disease.

The use of gemtuzumab may be dangerous if you have any of the conditions listed above.

Gemtuzumab is in the FDA pregnancy category D. This means that it is known to harm an unborn baby. Do not use gemtuzumab without first talking to your doctor if you are pregnant or could become pregnant during treatment. Discuss with your doctor the appropriate use of birth control during treatment with gemtuzumab. It is not known whether gemtuzumab passes into breast milk. Do not take gemtuzumab without first talking to your doctor if you are breast-feeding a baby.

How should I use Mylotarg (gemtuzumab)?

Gemtuzumab should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents.

Your doctor will determine the correct amount and frequency of treatment with gemtuzumab depending upon the type of cancer being treated and other factors. Talk to your doctor if you have any questions or concerns regarding the treatment schedule.

Your doctor will probably want you to have regularly scheduled blood tests and other medical evaluations during treatment with gemtuzumab to monitor progress and side effects.

Your healthcare provider will store gemtuzumab as directed by the manufacturer. If you are storing gemtuzumab at home, follow the directions provided by your healthcare provider.

What happens if I miss a dose?

Contact your doctor if you miss a dose of gemtuzumab.

What happens if I overdose?

If for any reason an overdose of gemtuzumab is suspected, seek emergency medical attention or contact your healthcare provider immediately.

Symptoms of a gemtuzumab overdose tend to be similar to side effects caused by the medication, although often more severe.

What should I avoid while using Mylotarg (gemtuzumab)?

Gemtuzumab can lower the activity of your immune system making you susceptible to infections. Avoid contact with people who have colds, the flu, or other contagious illnesses and do not receive vaccines that contain live strains of a virus (e.g., live oral polio vaccine) during treatment with gemtuzumab. In addition, avoid contact with individuals who have recently been vaccinated with a live vaccine. There is a chance that the virus can be passed on to you.

Mylotarg (gemtuzumab) side effects

If you experience any of the following serious side effects from gemtuzumab, contact your doctor immediately:

• an allergic reaction (including difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);

• decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; prolonged or unusual bleeding; black, bloody or tarry stools; or fever, chills, or signs of infection);

• difficulty breathing, shortness of breath, increased coughing, or chest pain;

• severe lightheadedness or fainting;

• liver problems (abdominal pain, yellowing of the skin or eyes); or

• fever or chills.

Other, less serious side effects may be more likely to occur. Continue taking gemtuzumab and talk to your doctor if you experience:

• nausea, vomiting, or loss of appetite;

• diarrhea;

• weakness;

• headache;

• dizziness;

• insomnia;

• rash or itching; or

• mouth sores.

Other side effects have also been reported. Discuss with your doctor any side effect that occurs during treatment with gemtuzumab.

What other drugs will affect Mylotarg (gemtuzumab)?

Do not receive "live" vaccines during treatment with gemtuzumab. Administration of a live vaccine may be dangerous during treatment with gemtuzumab.

Drugs other than those listed here may also interact with gemtuzumab. Talk to your doctor and pharmacist before taking any other prescription or over-the-counter medicines, including herbal products, during treatment with gemtuzumab.

Where can I get more information?

• Your healthcare provider may have additional information about gemtuzumab that you may read.

What does my medication look like?

Gemtuzumab is available with a prescription under the brand name Mylotarg. Other brand or generic formulations may also be available. Ask your healthcare provider or pharmacist any questions you have about this medication, especially if it is new to you.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 1.03. Revision Date: 2/13/04 4:08:43 PM.