gemtuzumab

Generic Name: gemtuzumab ( jem TOOZ oo mab)Brand Names: Mylotarg

What is gemtuzumab?

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

Gemtuzumab is used to treat acute myeloid leukemia, a type of blood cancer. Gemtuzumab is usually given to people who are at least 60 years old and have a relapse of their disease and who cannot receive other cancer medications.

Gemtuzumab may also be used for other purposes not listed in this medication guide.

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

You should not receive this medication if you are allergic to gemtuzumab Do not receive gemtuzumab without telling your doctor if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

Before receiving gemtuzumab, tell your doctor if you have any type of infection, lung or breathing problems, liver or kidney disease, if you have ever received a stem cell transplant, or if you are being treated with other cancer medications.

Gemtuzumab can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Your kidney or liver function may also need to be tested. Do not miss any follow-up visits to your doctor.

Contact your doctor at once if you develop signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), loss of appetite, nausea and vomiting, mouth sores, or unusual weakness. Do not receive a "live" vaccine while you are being treated with gemtuzumab, and avoid coming into contact with anyone who has recently received a live vaccine.

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

You should not receive this medication if you are allergic to gemtuzumab

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:

• any type of infection;

• lung or breathing problems;

• liver disease;
• kidney disease;

• if you have ever received a stem cell transplant; or

• if you being treated with other cancer medications.

FDA pregnancy category D. Gemtuzumab can cause harm to an unborn baby or cause birth defects. Before you receive gemtuzumab, tell your doctor if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment. It is not known whether gemtuzumab passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How is gemtuzumab given?

Gemtuzumab is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting. The medicine must be given slowly through an IV infusion, and can take at least 2 hours to complete.

Gemtuzumab can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill.

Contact your doctor at once if you develop signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), loss of appetite, nausea and vomiting, mouth sores, or unusual weakness.

To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Your kidney or liver function may also need to be tested. Do not miss any follow-up visits to your doctor.

What happens if I miss a dose?

Contact your doctor if you miss an appointment for your gemtuzumab injection.

What happens if I overdose?

Since gemtuzumab is given by a healthcare professional, an overdose is not likely to occur.

Symptoms of a gemtuzumab overdose are not known.

What should I avoid while using gemtuzumab?

Do not receive a "live" vaccine while you are being treated with gemtuzumab, and avoid coming into contact with anyone who has recently received a live vaccine. The live vaccine may not work as well during this time, and may not fully protect you from disease. There is also chance that the virus could be passed on to you. Live vaccines include measles, mumps, rubella (MMR), oral polio, chickenpox (varicella), BCG (Bacillus Calmette and Guérin), and nasal flu vaccine.

Gemtuzumab side effects

Some people receiving a gemtuzumab injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, nauseated, light-headed, sweaty, or have fever, chills, or trouble breathing within 24 hours after receiving the injection. Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

• pain in your upper right stomach, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• swelling, rapid weight gain;

• feeling like you might pass out;

• pale skin, easy bruising or bleeding (such as nosebleeds), purple or red pinpoint spots under your skin;

• fever, chills, body aches, unusual weakness, flu symptoms;

• white patches or sores inside your mouth or on your lips;

• chest pain or tightness, feeling short of breath;

• lower back pain, blood in your urine;

• increased thirst, fruity breath odor, increased urination;

• urinating less than usual or not at all;

• numbness or tingly feeling around your mouth;

• muscle weakness, tightness, or contraction, overactive reflexes;

• fast or slow heart rate, weak pulse; or

• confusion, uneven heart rate, leg discomfort, muscle weakness or limp feeling.

Less serious side effects may include:

• nausea, vomiting;

• diarrhea or constipation;

• headache;

• dizziness, anxiety, depressed mood; or

• sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Gemtuzumab Dosing Information

Usual Geriatric Dose for Acute Myeloid Leukemia:

For use in the treatment of patients with CD33 positive acute myeloid leukemia in first relapse who are 60 years of age or older and who are not considered candidates for other cytotoxic chemotherapy:9 mg/m2 administered as a two hour intravenous infusion onceVital signs should be monitored during infusion and for four hours following infusion.The recommended treatment course with gemtuzumab is a total of two doses with fourteen days between the doses. (Full recovery from hematologic toxicities is not a requirement for administration of the second dose.)

Usual Pediatric Dose for Acute Myeloid Leukemia:

As a part of combination therapy: Relapsed/refractory AML: Children less than 3 years: 0.07 to 0.1 mg/kg/dose Children greater than or equal to 3 years: 2 to 3 mg/m2/doseNewly diagnosed childhood AML: 3 mg/m2/dose (no dose adjustment for age or body surface area less than 0.6 m2)Children: Monotherapy: Phase I (MTD): Children less than 3 years: 0.2 mg/kg/dose for a total of 2 doses separated by 14 days Children greater than 3 years: 6 mg/m2/dose for a total of 2 doses separated by 14 days

What other drugs will affect gemtuzumab?

Tell your doctor about all other chemotherapy treatments you are receiving.

There may be other drugs that can interact with gemtuzumab. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your doctor or pharmacist can provide more information about gemtuzumab.

• 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: 2.04. Revision Date: 10/12/2009 8:51:51 AM.