Important Safety Information

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 candidates for — or who have failed — bone marrow transplantation.

There is no evidence to support the safety and efficacy of Adagen are 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 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.

The following adverse reactions have been reported during postapproval use of Adagen (pegademase bovine) Injection. Because these reactions are reported voluntarily from a very small population, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Hematologic events: hemolytic anemia, autoimmune hemolytic anemia, thrombocythemia.

Dermatologic events: injection - site erythema, urticaria.