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- 17-adenosine 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:

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.

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