GLASSIA IS Clinically proven to help increase Alpha-1 antitrypsin levels¹

Demonstrated safety profile¹

• The serious adverse reaction observed during clinical trials^‡ with GLASSIA was exacerbation of chronic obstructive pulmonary disease (COPD)¹
• The most common adverse reactions during clinical trials were headache and upper respiratory infection¹

Hypersensitivity: GLASSIA may contain trace amounts of IgA. Monitor vital signs continuously and observe the patient throughout the infusion. If hypersensitivity symptoms occur, discontinue the infusion and administer appropriate emergency treatment. Have epinephrine and/or other appropriate supportive therapy available for any acute anaphylactic or anaphylactoid reaction.

Please see additional Important Safety Information below.

^*Study design: The study was a randomized, double-blind trial with partial crossover involving 50 Alpha-1 PI deficient patients receiving GLASSIA (n=33) or the comparator (n=17) at a dose of 60 mg/kg IV per week for 12 weeks. From Weeks 13 to 24, all patients received open-label GLASSIA at 60 mg/kg IV per week. The objectives of the study were to: demonstrate the pharmacokinetics of antigenic and/or functional Alpha-1 PI in GLASSIA were not inferior to the control; and determine whether GLASSIA maintained antigenic and/or functional Alpha-1 PI of at least 11 μM (57 mg/dL).¹

^†The effect of augmentation therapy on pulmonary exacerbations and on the progression of emphysema in Alpha-1 deficiency has not been conclusively demonstrated in randomized, controlled trials.

^‡Safety of GLASSIA was evaluated in the pivotal study and an open-label, non-parallel, dose-escalation trial involving 65 subjects with pre-augmentation therapy serum Alpha-1 PI levels less than 11 μM.

To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals U.S.A. at 1-877-TAKEDA-7 (1-877-825-3327) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.