Gemtuzumab Ozogamicin Injection

What is this medication?

GEMTUZUMAB OZOGAMICIN (jem TOOZ oo mab oh zoe ga MY sin) treats leukemia. It works by blocking a protein that causes cancer cells to grow and multiply. This helps to slow or stop the spread of cancer cells.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Mylotarg

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Heart disease
• Irregular heartbeat or rhythm
• Liver disease
• Low levels of calcium, magnesium, or potassium in the blood
• An unusual or allergic reaction to gemtuzumab ozogamicin, other medications, foods, dyes, or preservatives
• If you or your partner are pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

This medication is injected into a vein. It is given by your care team in a hospital or clinic setting.

Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 1 month for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

Keep appointments for follow-up doses. It is important not to miss your dose. Call your care team if you are unable to keep an appointment.

What may interact with this medication?

Do not take this medication with any of the following:

• Cisapride
• Dronedarone
• Pimozide
• Thioridazine

This medication may also interact with the following:

• Other medications that causes heart rhythm changes, such as dofetilide, ziprasidone

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Your condition will be monitored carefully while you are receiving this medication.

You may need blood work while taking this medication.

This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

This medication may increase your risk to bruise or bleed. Call your care team if you notice any unusual bleeding.

Talk to your care team if you or your partner wish to become pregnant or think you might be pregnant. This medication can cause serious birth defects if taken during pregnancy and for at least 6 months after the last dose. A negative pregnancy test is required before starting this medication. A reliable form of contraception is recommended while taking this medication and for 6 months after the last dose. Talk to your care team about effective forms of contraception. Do not father a child while taking this medication and for at least 3 months after the last dose. Use a condom while having sex during this time period.

Do not breast-feed while taking this medication and for at least 1 month after the last dose.

This medication may cause infertility. Talk with your care team if you are concerned about your fertility.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds, red or dark brown urine, small red or purple spots on skin, unusual bruising or bleeding
• Bleeding in the brain—severe headache, stiff neck, confusion, dizziness, change in vision, numbness or weakness of the face, arm, or leg, trouble speaking, trouble walking, vomiting
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
• Infusion reactions—chest pain, shortness of breath or trouble breathing, feeling faint or lightheaded
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Constipation
• Headache
• Loss of appetite
• Nausea
• Pain, redness, or swelling with sores inside the mouth or throat
• Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

This medication is given in a hospital or clinic. It will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.