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Adagen

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Adagen

ADAGEN®
(pegademase bovine) Injection

DRUG DESCRIPTION

ADAGEN® (pegademase bovine) Injection is a modified enzyme used for enzyme replacement therapy for the treatment of severe combined immunodeficiency disease (SCID) associated with a deficiency of adenosine deaminase.

ADAGEN® (pegademase bovine) Injection is supplied in an isotonic, pyrogen free, sterile solution, pH 7.2-7.4, for intramuscular injection only. The solution is clear and colorless. It is supplied in 1.5 mL single-dose vials. The chemical name for ADAGEN® (pegademase bovine) Injection is (monomethoxypolyethylene glycol succinimidyl) 11-17adenosine deaminase. It is a conjugate of numerous strands of monomethoxypolyethylene glycol (PEG), molecular weight 5,000, covalently attached to the enzyme adenosine deaminase (ADA). ADA (adenosine deaminase EC 3.5.4.4) used in the manufacture of ADAGEN® (pegademase bovine) Injection is derived from bovine intestine.

The structural formula of ADAGEN® (pegademase bovine) Injection is:

ADAGEN® (pegademase bovine) Structural Formula Illustration

x ≈ 114 oxyethylene groups per PEG strand.
y ≈ 11-17 primary amino groups of lysine onto which succinyl PEG is attached.

Each milliliter of ADAGEN® (pegademase bovine) Injection contains:

Pegademase bovine ................................................................ 250 units*
Monobasic sodium phosphate, USP ........................................... 1.20 mg
Dibasic sodium phosphate, USP ................................................ 5.58 mg
Sodium Chloride, USP ................................................................ 8.50 mg
Water for injection, USP..................................................... q.s. to 1.0 mL

*One unit of activity is defined as the amount of ADA that converts 1μM of adenosine to inosine per minute at 25°C and pH 7.3.

What are the possible side effects of pegademase bovine (Adagen)?

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...

Read All Potential Side Effects and See Pictures of Adagen »

Last reviewed on RxList: 6/23/2014
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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