Apadamtase Alfa

1 INDICATIONS AND USAGE ADZYNMA (ADAMTS13, recombinant-krhn) is a human recombinant “A disintegrin and metalloproteinase with thrombospondin motifs 13” (rADAMTS13) indicated for prophylactic or on demand enzyme replacement therapy (ERT) in adult and pediatric patients with congenital thrombotic thrombocytopenic purpura (cTTP) [see Use in Specific Populations (8.4) , Clinical Studies (14) ]. ADZYNMA (ADAMTS13, recombinant-krhn) is a human recombinant “A disintegrin and metalloproteinase with thrombospondin motifs 13” (rADAMTS13) indicated for prophylactic or on demand enzyme replacement therapy (ERT) in adult and pediatric patients with congenital thrombotic thrombocytopenic purpura (cTTP). ( 1 )

6 ADVERSE REACTIONS Most common adverse reactions (>5% of subjects) reported in clinical trials were headache, diarrhea, migraine, abdominal pain, nausea, upper respiratory tract infection, dizziness, and vomiting. Most common adverse reactions (incidence >5%) are headache, diarrhea, migraine, abdominal pain, nausea, upper respiratory tract infection, dizziness, and vomiting. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals U.S.A., Inc. at 1-877-TAKEDA-7 (1-877-825-3327) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

8.1 Pregnancy Risk Summary The safety of ADZYNMA for use during pregnancy has not been established in controlled clinical trials. Limited data with ADZYNMA use during pregnancy are insufficient to inform a drug-associated risk of adverse developmental outcomes. 1 In determining whether ADZYNMA should be used in pregnancy, healthcare providers should balance the potential benefits with the potential risks. The background rate of major birth defects and miscarriage in the indicated population is unknown. In the U.S.

5 WARNINGS AND PRECAUTIONS Hypersensitivity reactions may occur. Discontinue ADZYNMA if hypersensitivity symptoms occur and administer appropriate emergency treatment. ( 5.1 ) Immunogenicity: Patients may develop antibodies to rADAMTS13 which could potentially result in a decreased or lack of response to rADAMTS13. Patients may develop antibodies to host cell proteins which could potentially result in adverse reactions. There are no data on risk in previously untreated patients (subjects naïve to plasma-based products). ( 5.2 ) 5.1 Hypersensitivity Allergic-type hypersensitivity including anaphylactic reactions may occur with ADZYNMA. 4 CONTRAINDICATIONS ADZYNMA is contraindicated in patients who have manifested life threatening hypersensitivity reactions to ADZYNMA or its components [see Description (11) ] . Do not use in patients who have manifested life threatening hypersensitivity reactions to ADZYNMA or its components. ( 4 )