Daclizumab Solution for injection

What is this medicine?

DACLIZUMAB (da KLIZ yoo mab) works in the body's immune system. It is used to prevent transplant organ rejection.

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:

• infection

• an unusual or allergic reaction to daclizumab, mouse proteins, 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 given by a health care professional in a hospital or clinic setting.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 11 months of age 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?

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?

• some vaccines

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?

Visit your doctor or health care professional for regular checks on your progress. Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse.

Your blood sugar may be high while you are taking this medicine. Ask your doctor or health care professional for advice if you are diabetic and notice a change in your blood sugar level.

If you are a woman who could become pregnant, use effective birth control during treatment with this medicine and for at least 4 months after stopping this therapy. 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.

Call your doctor or health care professional if you get a cold or other infection while receiving this medicine. Do not treat yourself. This medicine may decrease your body's ability to fight infection.

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

• changes in vision

• chest pain

• fever, chills, or any other sign of infection

• pain, tingling, numbness in the hands or feet

• swelling of the ankles, feet, hands

• trouble passing urine or change in the amount of urine

• unusual bleeding or bruising

• unusually high or low blood pressure

• unusually weak or tired

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

• constipation or diarrhea

• headache

• hemorrhoids

• nausea

• pain, redness at site where injected

• stomach gas, upset

• trouble sleeping

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?

This drug is given in a hospital or clinic and will not be stored at home.