Pegademase Solution for injection

What is this medicine?

PEGADEMASE BOVINE (peg AD e mase BOE vine) is a drug that is used to replace an enzyme that is missing in patients with severe combined immunodeficiency disease associated with adenosine deaminase deficiency. It is not a cure.

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:

• bleeding problems

• infection

• low blood platelet counts

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

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for injection into a muscle. It is usually given by a health care professional in a hospital or clinic setting.

If you get this medicine at home, you will be taught how to prepare and give this medicine. Use exactly as directed. Take your medicine at regular intervals. Do not take your medicine more often than directed.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or healthcare provider to get one.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as newborns, precautions do apply. 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.

If you receive your medicine at a clinic or hospital, call your doctor or health care professional if you are unable to keep an appointment.

If you take your medicine at home, call your doctor immediately if you miss a dose. Do not take double or extra doses.

What may interact with this medicine?

• vidarabine

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 for regular check ups. You will need blood work done while you are taking 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 difficulties

• dizziness

• feeling faint or lightheaded, falls

• 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):

• headache

• pain or redness at site where injected

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.

If you are using this medicine at home, store it in a refrigerator between 2 and 8 degrees C (36 and 46 degrees F). Do not freeze. Throw away any unused medicine after the expiration date on the label.