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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:
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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.
Last reviewed on RxList: 12/4/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Adagen Information
Report Problems to the Food and Drug Administration
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