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pegademase bovine

Generic Name: pegademase bovine (peg AD e mase BOE vine)
Brand Name: Adagen

What is pegademase bovine?

Pegademase bovine is a man-made form of an enzyme called adenosine deaminase (ADA). ADA is important in the body for preventing the buildup of certain proteins harmful to the white blood cells that help your body fight infections.

Pegademase bovine is used to replace ADA in people with severe combined immunodeficiency disease (SCID).

Pegademase bovine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about pegademase bovine?

You should not use pegademase bovine if have severe thrombocytopenia (low levels of platelets in blood).

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What should I discuss with my healthcare provider before using pegademase bovine?

You should not use pegademase bovine if you are allergic to it, or if you have:

  • severe thrombocytopenia (low levels of platelets in blood).

To make sure pegademase bovine is safe for you, tell your doctor if you have:

  • easy bruising or bleeding.

FDA pregnancy category C. It is not known whether pegademase bovine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether pegademase bovine passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How should I use pegademase bovine?

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Pegademase bovine is injected into a muscle. You may be shown how to use injections at home. Do not self-inject this medicine if you do not understand how to give the injection and properly dispose of used needles and syringes.

Pegademase bovine is usually given once every 7 days. Follow your doctor's dosing instructions very carefully.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Each single-use vial (bottle) of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

Do not use pegademase bovine if it has changed colors or has particles in it. Call your pharmacist for new medication.

While using pegademase bovine, your blood will need to be tested often.

It may take up to 6 months before your immune system improves and you have fewer infections. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

Call your doctor if your symptoms do not improve after the first few weeks of treatment.

Store in the refrigerator, do not freeze. Throw away the medicine if it has become frozen.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose of pegademase bovine.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using pegademase bovine?

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Pegademase bovine side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

  • pale or yellowed skin, dark colored urine, fever, confusion or weakness; or

  • signs of infection--fever, chills, sore throat, mouth sores, flu symptoms, skin sores or swelling.

Common side effects may include:

  • headache; or

  • redness or itching where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Pegademase bovine dosing information

Usual Pediatric Dose for Adenosine Deaminase Deficiency:

-First dose: 10 units/kg intramuscularly
-Second dose: 15 units/kg intramuscularly
-Third dose: 20 units/kg intramuscularly

-Maintenance dose: 20 units/kg/week intramuscularly
-Maximum dose: 30 units/kg intramuscularly

Comments:
-This drug should be administered every 7 days.
-Dose should be individualized based on monitoring of plasma adenosine deaminase (ADA) activity levels and red blood cell deoxyadenosine triphosphate (dATP) content.
-Dose increases of 5 units/kg/week may be necessary.
-Dose proportionality has not been established and patients should be closely monitored when the dosage is increased.

Use: Enzyme replacement therapy for ADA deficiency in infants from birth and children of any age with severe combined immunodeficiency disease (SCID) who are not suitable candidates for, or have failed, bone marrow transplantation.

What other drugs will affect pegademase bovine?

Other drugs may interact with pegademase bovine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your pharmacist can provide more information about pegademase bovine.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 4.01. Revision Date: 2014-12-15, 12:03:43 PM.

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