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Adagen (Pegademase Bovine) - Indications and Dosage

 
 



INDICATIONS AND USAGE

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.

DOSAGE AND ADMINISTRATION

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 ENZON Pharmaceuticals, Inc., 20 Kingsbridge Road, Piscataway, NJ 08854-3969. Telephone 908-541-8600.

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 is10 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 per-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.

HOW SUPPLIED

ADAGEN ® (pegademase bovine) Injection is a clear, colorless solution for intramuscular injection. Each vial contains 250 units/mL and is supplied as a 1.5 mL single-use vial, in boxes of 4 vials (NDC-57665-001-01).

Refrigerate. Store between + 2° C and + 8° C 36° F and 46° F). DO NOT FREEZE. ADAGEN ® (pegademase bovine) Injection should not be stored at room temperature. This product should not be used if there are any indications that it may have been frozen.

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