Blinatumomab Solution for injection

What is this medicine?

BLINATUMOMAB (BLIN a TOOM oh mab) is a monoclonal antibody. It is used to treat acute lympoblastic leukemia (ALL).

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

What should I tell my health care provider before I take this medicine?

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

• history of radiation therapy

• infection

• liver disease

• seizures

• an unusual or allergic reaction to blinatumomab, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for infusion into a vein. It is usually given by a health care professional 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 pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you've 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 medicine?

Interactions have not been studied. However, this medicine may interact with the following medications:

• cyclosporine

• warfarin

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 medicine?

Call your doctor or health care professional for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This drug decreases your body's ability to fight infections. Try to avoid being around people who are sick.

Your condition will be monitored carefully while you are receiving this medicine. You may need blood work done while you are taking this medicine.

Do not drive, use machinery, or do anything that needs mental alertness while on this medicine.

What side effects may I notice from receiving this medicine?

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

• confusion

• headache

• loss of balance

• loss of consciousness

• low blood counts - this medicine may decrease the number of white blood cells, red blood cells and platelets; you may be at increased risk for infections and bleeding

• nausea, vomiting

• seizures

• signs and symptoms of infection like fever or chills; cough; sore throat; pain or trouble passing urine

• signs and symptoms of low blood pressure like dizziness; feeling faint or lightheaded, falls; unusually weak or tired

• trouble speaking

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

• swelling of the ankles, feet, hands

• tremors

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 medicine?

Keep out of the reach of children.

This drug is usually given in a hospital or clinic. In rare cases, this medicine may be given at home. If you are using this medicine at home, you will be instructed on how to store this medicine.

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.