Moxetumomab Pasudotox Injection

What is this medication?

MOXETUMOMAB PASUDOTOX (mox e toom oh mab pa soo doe tox) 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): LUMOXITI

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

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

• Hemolytic-uremic syndrome or thrombotic microangiopathy
• Kidney disease
• An unusual or allergic reaction to moxetumomab pasudotox or other medications, foods, dyes, or preservatives
• 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.

A special MedGuide will be given to you before each treatment. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. Special care may be needed.

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?

Interactions have not been studied.

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.

Drink fluids as directed to prevent dehydration.

Talk to your care team if you wish to become pregnant or think you might be pregnant. This medication can cause serious birth defects if taken during pregnancy and for 30 days after the last dose. A reliable form of contraception is recommended while taking this medication and for 30 days after the last dose. Talk to your care team about effective forms of contraception.

Do not breast-feed while taking this medication.

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
• Capillary leak syndrome—stomach or muscle pain, unusual weakness or fatigue, feeling faint or lightheaded, decrease in the amount of urine, swelling of the ankles, hands, or feet, trouble breathing
• Infusion reactions—chest pain, shortness of breath or trouble breathing, feeling faint or lightheaded
• Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet
• Low calcium level—muscle pain or cramps, confusion, tingling, or numbness in the hands or feet
• Stomach pain, bloody diarrhea, pale skin, unusual weakness or fatigue, decrease in the amount of urine, which may be signs of hemolytic uremic syndrome

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

• Constipation
• Diarrhea
• Fatigue
• Headache
• Nausea
• Swelling of the ankles, hands, or feet

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.