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INDICATION & IMPORTANT SAFETY INFO

INDICATION

GLASSIA is an Alpha₁-Proteinase Inhibitor (Alpha₁-PI) for chronic augmentation and maintenance therapy in adults with clinically evident emphysema due to severe hereditary deficiency of Alpha₁-PI. No randomized, controlled trials have demonstrated effects of Alpha₁-PI augmentation therapy on pulmonary exacerbations or emphysema progression. Clinical data on long-term effects of treatment with GLASSIA are not available. Please see full Indication and Limitations of Use below.

IMPORTANT SAFETY INFORMATION

Contraindications

Immunoglobulin A (IgA) deficient patients with antibodies against IgA See more safety info.

INDICATION AND LIMITATIONS OF USE:

GLASSIA is an Alpha₁-Proteinase Inhibitor (Human) (Alpha₁-PI) indicated for chronic augmentation and maintenance therapy in adults with clinically evident emphysema due to severe hereditary deficiency of Alpha₁-PI (alpha₁-antitrypsin deficiency).

The effect of augmentation therapy with GLASSIA or any Alpha₁-PI product on pulmonary exacerbations and on the progression of emphysema in Alpha₁-PI deficiency has not been conclusively demonstrated in randomized, controlled clinical trials. Clinical data demonstrating the long-term effects of chronic augmentation and maintenance therapy of individuals with GLASSIA are not available. GLASSIA is not indicated as therapy for lung disease in patients in whom severe Alpha₁-PI deficiency has not been established.

IMPORTANT SAFETY INFORMATION

Contraindications

Immunoglobulin A (IgA) deficient patients with antibodies against IgA
History of anaphylaxis or other severe systemic reaction to Alpha₁-PI products.

Warnings and Precautions

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.

Transmissible Infectious Agents: Because GLASSIA is made from human plasma it may carry a risk of transmitting infectious agents such as viruses, the variant Creutzfeldt-Jakob disease (vCJD) and theoretically, the Creutzfeldt-Jakob disease (CJD) agent and other pathogens. No seroconversions for hepatitis B or C or human immunodeficiency virus or any other known infectious agent were reported with the use of GLASSIA during the clinical trials.

Adverse Reactions

The serious adverse reaction observed during clinical trials with GLASSIA was exacerbation of chronic obstructive pulmonary disease (COPD).

The most common adverse reactions during clinical trials were headache and upper respiratory infection.

Please click for GLASSIA Full Prescribing Information.