Pegademase (bovine), Injection

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KEY POINTS

• This medicine is given by injection to replace the enzyme adenosine deaminase in people with severe combined immunodeficiency disease. Use it exactly as directed. Do not stop taking this medicine without your healthcare provider's approval. You may get a serious infection if you stop taking the medicine too soon.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: enzyme replacement therapy

Generic and brand names: pegademase (bovine), injection; Adagen

What is this medicine used for?

This medicine is given by injection (shot) to replace the enzyme adenosine deaminase (ADA), which helps increase white blood cells and decrease the risk of infection in people with severe combined immunodeficiency disease (SCID). It is used in people who are not candidates for or have failed bone marrow transplant.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Tell your healthcare provider if you have ever had:

• An allergy to any medicines
• A blood disorder or bleeding problem
• A weakened immune system from cancer treatment, diseases such as HIV/AIDS, or from taking steroid medicines or medicines to prevent organ transplant rejection

Females of childbearing age: Tell your healthcare provider if you are pregnant or if you plan to become pregnant. It is not known if this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

Often you can give yourself these shots or have someone at home give them to you. Check the label on the medicine for directions about your specific dose. Be sure you know when to use the medicine and how much medicine you should use. Carefully follow the instructions for using this medicine. If you are not sure how to use this medicine, ask your healthcare provider or pharmacist for help.

What if I miss a dose?

Try not to miss a dose. If you miss a dose, contact your healthcare provider.

What if I overdose?

Symptoms of an acute overdose have not been reported.

What should I watch out for?

It is important to follow the treatment schedule exactly as your healthcare provider has instructed. Use the medicine for as long as prescribed. It may take several weeks until you start to feel better. Do not stop taking this medicine without your healthcare provider's approval. You may get a serious infection if you stop taking the medicine too soon.

You will need to have blood tests regularly while receiving this medicine. Keep all appointments for these tests.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you have received this medicine.

What are the possible side effects?

Along with its needed effects, this medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; tightness in your chest; swelling of your lips, tongue or throat; trouble breathing).

Serious (Report these to your healthcare provider right away.): Fever, fatigue, sore throat that does not go away.

Other: Headache; redness, swelling, or pain at the injection site.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Pentostatin (Nipent)

If you are not sure if your child's medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your child's medicines (prescription, nonprescription, supplements, natural remedies, and vitamins) with you. Be sure that you tell all healthcare providers who treat your child about all the products your child is taking.

How should I store this medicine?

Store this medicine in the refrigerator. Do not let it freeze. Protect it from heat, high humidity, and bright light. Do not use the medicine if it is cloudy or has particles floating in it.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.