Moxetumomab pasudotox injection

What is this medication?

MOXETUMOMAB PASUDOTOX (mox e toom oh mab pa soo doe tox) is a monoclonal antibody and a chemotherapy drug. It is used to treat hairy-cell leukemia.

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 medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

This medicine is for infusion into a vein. It is given by a health care professional in a hospital or clinic setting.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine 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?

It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

What may interact with this medication?

Interactions have not been studied.

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.

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 medicine. You may need blood work done while you are taking this medicine.

Drink fluids as directed to prevent dehydration.

Do not become pregnant while taking this medicine or for at least 30 days after stopping it. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• breathing problems
• changes in emotion or mood
• confusion
• cough
• dark yellow or brown urine
• fast heartbeat
• muscle cramps or muscle pain
• nausea, vomiting
• pain, tingling, numbness
• seizures
• signs and symptoms of kidney injury like trouble passing urine or change in the amount of urine
• signs and symptoms of low blood pressure like dizziness, feeling faint or lightheaded, falls; unusually weak or tired
• stomach pain
• swelling in your face, arms, or legs
• unusual bleeding or bruising
• weight gain

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

• constipation
• diarrhea
• headache

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 drug is given in a hospital or clinic and 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.