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Adagen Generic Name & Formulations
Legal Class
Rx
General Description
Pegademase bovine 250 Units/mL; soln for IM inj; preservative-free.
Pharmacological Class
Enzyme.
How Supplied
Single-use vial (1.5mL)—4
Manufacturer
Adagen Indications
Indications
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 Dosage and Administration
Adult
Not applicable.
Children
Individualize. Give by IM inj every 7 days. 1st dose: 10 Units/kg. 2nd dose: 15 Units/kg. 3rd dose: 20 Units/kg. Maintenance dose: 20 Units/kg per week. May increase by 5 Units/kg/week if necessary; max single dose 30 Units/kg. Biochemical goals: maintain plasma ADA activity (trough levels before maintenance inj) in the range of 15–35μmol/hr/mL; decline in erythrocyte dATP to ≤0.005–0.015μmol/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.
Adagen Contraindications
Contraindications
As preparatory or support therapy for bone marrow transplantation. Severe thrombocytopenia.
Adagen Boxed Warnings
Not Applicable
Adagen Warnings/Precautions
Warnings/Precautions
Determine plasma ADA activity and red cell dATP prior to treatment. Measure plasma ADA activity (pre-injection) every 1–2 weeks during the first 8–12 weeks to establish dose. Once dATP level has fallen adequately, measure 2–4 times a year during the remainder of the first year and 2–3 times a year thereafter. Between 3 and 9 months, determine plasma ADA twice a month, then monthly until after 18–24 months of treatment. After 2 years of maintenance therapy, measure plasma ADA every 2–4 months and red cell dATP twice yearly. Monitor immune function and clinical status; improvement may be gradual but should be apparent by end of first year of therapy. Pregnancy (Cat.C). Nursing mothers.
Adagen Pharmacokinetics
See Literature
Adagen Interactions
Interactions
May potentiate vidarabine. May be antagonized by 2'-deoxycoformycin.
Adagen Adverse Reactions
Adverse Reactions
Headache, inj site pain; possible antibody formation (perform assay if suspected).
Adagen Clinical Trials
See Literature
Adagen Note
Not Applicable
Adagen Patient Counseling
See Literature
