This information is not for clinical use. These highlights do not include all the information needed to use Adagen safely and effectively. Before taking Adagen please consult with your doctor. See full prescribing information for Adagen.

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.

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Contraindications

There is no evidence to support the safety and efficacy of ADAGEN® (pegademase bovine) Injection as preparatory or support therapy for bone marrow transplantation. Since ADAGEN® (pegademase bovine) Injection is administered by intramuscular injection, it should be used with caution in patients with thrombocytopenia and should not be used if thrombocytopenia is severe.

Adverse Reactions

Clinical experience with ADAGEN® (pegademase bovine) Injection has been limited. The following adverse reactions were reported: 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. Lymphomas To report SUSPECTED ADVERSE REACTIONS, contact Leadiant Biosciences, Inc. at 1-888-393-4584 or by email at drugsafety@leadiant.com or contact the FDA at 1-800-FDA-1088 or www.fda.gov/safety/medwatch.

Drug Interactions

Drug Interactions There are no known drug interactions with ADAGEN® (pegademase bovine) Injection. However, Vidarabine is a substrate for ADA and 2′-deoxycoformycin is a potent inhibitor of ADA. Thus, the activities of these drugs and ADAGEN® (pegademase bovine) Injection could be substantially altered if they are used in combination with one another.