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Brand Names: Mylotarg

Generic Name: gemtuzumab (Pronunciation: jem TOOZ oo mab)

• What is gemtuzumab (Mylotarg)?
• What are the possible side effects of gemtuzumab (Mylotarg)?
• What is the most important information I should know about gemtuzumab (Mylotarg)?
• What should I discuss with my healthcare provider before taking gemtuzumab (Mylotarg)?
• How is gemtuzumab given (Mylotarg)?
• What happens if I miss a dose (Mylotarg)?
• What happens if I overdose (Mylotarg)?
• What should I avoid while using gemtuzumab (Mylotarg)?
• What other drugs will affect gemtuzumab (Mylotarg)?
• Where can I get more information?

What is gemtuzumab (Mylotarg)?

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 are the possible side effects of gemtuzumab (Mylotarg)?

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.

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

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.