Clinical experience with ADAGEN® (pegademase bovine) Injection has been limited. 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 identified during post-approval 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, auto-immune hemolytic anemia, thrombocythemia, thrombocytopenia and autoimmune thrombocytopenia.
Dermatological events: injection site erythema, urticaria.
To report SUSPECTED ADVERSE REACTIONS, contact Sigma-Tau Pharmaceuticals, Inc. at 1-888-393-4584 or by email at firstname.lastname@example.org or contact the FDA at 1-800-FDA-1088 or www.fda.gov/safety/medwatch.