Important Safety Information
There is no evidence to support the safety and efficacy of ADAGEN® as preparatory or support therapy for bone marrow transplantation. Since ADAGEN® is administered by intramuscular injection, it should be used with caution in patients with thrombocytopenia and should not be used if thrombocytopenia is severe.
The optimal dosage and schedule of administration should be established for each patient. Plasma ADA activity and red cell dATP should be determined prior to treatment. The treatment of SCID associated with ADA deficiency with ADAGEN® should be monitored by measuring plasma ADA activity and red blood cell dATP levels.
The following adverse reactions were reported during clinical trials: headache in one patient and pain at the injection site in two patients.
Please see full Prescribing Information for contraindications, precautions and adverse reactions.