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

Treats acute myeloid leukemia (AML).

Brand Name(s):

Mylotarg

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through an IV placed in a vein. It must be given slowly, so the needle will have to stay in place for at least 2 hours.
• 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.
• You may receive other medicines (including allergy medicine, fever medicine, steroids) before starting treatment with this medicine.
• Missed dose: 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.

• Some medicines can affect how gemtuzumab works. Tell your doctor if you are also using medicine for heart rhythm problems or a medicine containing calicheamicin.

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Use an effective form of birth control during treatment with this medicine and for at least 6 months after the last dose. Male patients with female partners should use an effective form of birth control during treatment and for at least 3 months after the last dose.
• Do not breastfeed during treatment with this medicine and for at least 1 month after the last dose.
• Tell your doctor if you have liver disease, blood problems, or a history of heart rhythm problems (including QT prolongation). Tell your doctor if you have had stem cell transplant.
• This medicine can cause the following problems:
  • Liver problems (including hepatic veno-occlusive disease or sinusoidal obstruction syndrome)
  • Infusion-related reactions
  • Bleeding problems, which may be life-threatening
  • Changes in heart rhythm
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• 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.
• This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

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
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fast, pounding, or uneven heartbeat
• Fever, chills, headache, cough, sore throat, body aches
• Lightheadedness, dizziness, fainting
• Tiny red dots on the skin, especially on the lower legs
• Unusual bleeding, bruising, or weakness
• Warmth or redness in your face, neck, arms, or upper chest

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

• Constipation
• Pain, itching, burning, swelling, bleeding, or a lump under your skin where the needle is placed
• Sores or white patches on your lips, mouth, or throat

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