pegademase bovine

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

What are pegademase bovine?

Pegademase bovine is the enzyme called adenosine deaminase (ADA). Without ADA, certain proteins accumulate that harm white blood cells. White blood cells are important for protecting the body from infection.

Pegademase bovine is used to replenish ADA which allows an increase in white blood cells and decreases the risk of infection in conditions such as severe combined immunodeficiency disease (SCID).

Pegademase bovine may also be used for purposes other than those listed in this medication guide.

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

Do not administer an injection if you are unsure how to properly do so, how much to inject, or how often to inject the medication. Call your doctor, nurse, or pharmacist to go over the instructions with you.

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Contact your doctor if you develop a fever; chills; sore throat; congestion; or redness, pain, or swelling around a wound or sore while using pegademase bovine. These may be signs of infection.

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

Before using pegademase bovine, tell your doctor if you

  • are undergoing radiation or receiving chemotherapy; or

  • have a bleeding disorder.

You may not be able to use pegademase bovine or you may require a dosage adjustment or special monitoring if you have any of the conditions listed above.

Pegademase bovine is in the FDA pregnancy category C. This means that it is not known whether pegademase bovine will be harmful to an unborn baby. Do not use pegademase bovine without first talking to your doctor if you are pregnant or could become pregnant during treatment.

It is not known whether pegademase bovine will be harmful to a nursing baby. Do not use pegademase bovine without first talking to your doctor if you are breast-feeding a baby.

How should I use pegademase bovine?

Use pegademase bovine exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Pegademase bovine is given by intramuscular (IM) injection. Your doctor, nurse, or pharmacist will give you specific instructions on how and where to inject the medication.

Do not administer an injection if you are unsure how to properly do so, how much to inject, or how often to inject the medication. Call your doctor, nurse, or pharmacist to go over the instructions with you.

Pegademase bovine is usually administered once every 7 days.

Do not inject a pegademase bovine that is discolored or that has particles in it.

Properly store and discard all syringes and needles.

Your doctor may want you to have regularly scheduled blood tests while using pegademase bovine to monitor effectiveness and possible side effects of the medication.

Do not stop taking pegademase bovine without talking to your doctor. It may take several weeks to 6 months to be fully effective. Stopping pegademase bovine may cause your immune system to become less effective and serious infections may occur.

Store pegademase bovine in the refrigerator between 2 and 8 degrees Celsius (36 to 46 degrees Fahrenheit) away from light, moisture, and the reach of children. Avoid freezing the medication. Do not use this product if there are any indications that it may have frozen.

What happens if I miss a dose?

Contact your doctor as soon as possible if you miss a dose of this medication.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of a pegademase bovine overdose are not known.

What should I avoid while using pegademase bovine?

There are no restrictions regarding foods, beverages, or activities during treatment with pegademase bovine unless otherwise directed by your doctor.

Pegademase bovine side effects

If you experience any of the following serious side effects, stop using the pegademase bovine and seek emergency medical treatment or contact your doctor immediately:

  • an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); or

  • signs of infection such as sore throat, fever or congestion.

Other, less serious side effects may be more likely to occur. Continue to use the pegademase bovine and talk to your doctor if you experience:

  • headache;

  • swelling, redness, or pain at the injection site.

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 Adult Dose for Adenosine Deaminase Deficiency:

Initial dose: 10 units/kg the first dose, 15 units /kg the second dose, and 20 units/kg the third dose given intramuscularly 7 days apart
Maintenance dose: 20 units/kg/week
Maximum dose: 30 units/kg

Comments:
-Dose should be individualized based on monitoring of plasma adenosine deaminase (ADA) activity levels and deoxyadenosine triphosphate (dATP) content
-Plasma ADA activity and red cell dATP should be determined prior to treatment.
-Increases of 5 units/week may be necessary
-Pegademase bovine injection should be used at the lowest effective dose in order to achieve therapeutic efficacy and minimize adverse effects.

Usual Pediatric Dose for Adenosine Deaminase Deficiency:

Initial dose: 10 units/kg the first dose, 15 units /kg the second dose, and 20 units/kg the third dose given intramuscularly 7 days apart
Maintenance dose: 20 units/kg/week
Maximum dose: 30 units/kg

Comments:
-Dose should be individualized based on monitoring of plasma adenosine deaminase (ADA) activity levels and deoxyadenosine triphosphate (dATP) content
-Plasma ADA activity and red cell dATP should be determined prior to treatment.
-Increases of 5 units/week may be necessary
-Pegademase bovine injection should be used at the lowest effective dose in order to achieve therapeutic efficacy and minimize adverse effects.

What other drugs will affect pegademase bovine?

Before using this medication, tell your doctor if you

  • are receiving vidarabine eye ointment (Vira-A).

You may not be able to use the pegademase bovine or you may require a dosage adjustment or special monitoring if you are taking the medication listed above.

Drugs other than those listed here may also interact with pegademase bovine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.

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: 3.02. Revision Date: 2010-12-15, 5:01:39 PM.

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