Adagen
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Uses
ADAGEN® (pegademase bovine) Injection is indicated for enzyme replacement therapy for adenosine deaminase (ADA) deficiency in patients with severe combined immunodeficiency disease (SCID) who are not suitable candidates for – or who have failed – bone marrow transplantation. ADAGEN® (pegademase bovine) Injection is recommended for use in infants from birth or in children of any age at the time of diagnosis. ADAGEN® (pegademase bovine) Injection is not intended as a replacement for HLA identical bone marrow transplant therapy. ADAGEN® (pegademase bovine) Injection is also not intended to replace continued close medical supervision and the initiation of appropriate diagnostic tests and therapy (e.g., antibiotics, nutrition, oxygen, gammaglobulin) as indicated for intercurrent illnesses.
History
There is currently no drug history available for this drug.
Other Information
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.
Sources
Adagen Manufacturers
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Sigma-tau Pharmaceuticals, Inc.
![Adagen (Pegademase Bovine) Injection, Solution [Sigma-tau Pharmaceuticals, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Adagen | Sigma-tau Pharmaceuticals, Inc.
Before prescribing ADAGEN® (pegademase bovine) Injection the physician should be thoroughly familiar with the details of this prescribing information. For further information concerning the essential monitoring of ADAGEN® (pegademase bovine) Injection therapy, the prescribing physician should contact Sigma-Tau Pharmaceuticals, Inc., Gaithersburg, MD 20878. Telephone 1-866-792-5172.
ADAGEN® (pegademase bovine) Injection is recommended for use in infants from birth or in children of any age at the time of diagnosis.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permits.
ADAGEN® (pegademase bovine) Injection should not be diluted nor mixed with any other drug prior to administration.
ADAGEN® (pegademase bovine) Injection should be administered every 7 days as an intramuscular injection. The dosage of ADAGEN® (pegademase bovine) Injection should be individualized. The recommended dosing schedule is 10 U/kg for the first dose, 15 U/kg for the second dose, and 20 U/kg for the third dose. The usual maintenance dose is 20 U/kg per week. Further increases of 5 U/kg/week may be necessary, but a maximum single dose of 30 U/kg should not be exceeded. Plasma levels of ADA more than twice the upper limit of 35 μmol/hr/mL have occurred on occasion in several patients, and have been maintained for several weeks in one patient who received twice weekly injections (20 U/kg per dose) of ADAGEN® (pegademase bovine) Injection. No adverse effects have been observed at these higher levels; there is no evidence that maintaining pre-injection plasma ADA above 35 μmol/hr/mL produces any additional clinical benefits.
Dose proportionality has not been established and patients should be closely monitored when the dosage is increased. ADAGEN® (pegademase bovine) Injection is not recommended for intravenous administration.
The optimal dosage and schedule of administration should be established for each patient based on monitoring of plasma ADA activity levels (trough levels before maintenance injection) and biochemical markers of ADA deficiency (primarily red cell dATP content). Since improvement in immune function follows correction of metabolic abnormalities, maintenance dosage in individual patients should be aimed at achieving the following biochemical goals: 1) maintain plasma ADA activity (trough levels before maintenance injection) in the range of 15-35 μmol/hr/mL (assayed at 37°C); and 2) decline in erythrocyte dATP to ≤ 0.005-0.015 μmol/mL packed erythrocytes, or ≤ 1% of the total erythrocyte adenine nucleotide (ATP + dATP) content, with a normal ATP level, as measured in a pre-injection sample. In addition, continued monitoring of immune function and clinical status is essential in any patient with a primary immunodeficiency disease and should be continued in patients undergoing treatment with ADAGEN® (pegademase bovine) Injection.
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