CINRYZE for the Treatment of Hereditary Angioedema Attacks in Children Under the Age of 12

Each subject received CINRYZE for treatment of a single acute angioedema attack.

Inclusion Criteria:

To be eligible for this protocol, subjects must:

1. Be at least 10 kg of body weight.

2. Have a confirmed diagnosis of HAE.

3. Have an acute HAE attack and be able to initiate treatment within 8 hours after onset
of symptoms.

Exclusion Criteria:

To be eligible for this protocol, subjects must not:

1. Have any active infectious illness.

2. Have had a prior HAE attack and/or received any C1 INH product within 7 days prior to
dosing with study drug.

3. Have received therapy with antifibrinolytics (e.g., tranexamic acid), androgens (e.g.,
danazol, oxandrolone, stanozolol, or testosterone), ecallantide (Kalbitor®), or
icatibant (Firazyr®) within 7 days prior to dosing with study drug.

4. Have a history of allergic reaction to C1 INH products, including CINRYZE (or any of
the components of CINRYZE), or other blood products.

5. Have participated in any other investigational drug evaluation within 30 days prior to
dosing with study drug, or have previously received treatment with CINRYZE in this
study at any time.