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IMPORTANT SAFETY INFORMATION

USE

GLASSIA is a medicine used to treat adults with lung disease (emphysema) caused by severe Alpha₁-antitrypsin (AAT) deficiency. GLASSIA increases the levels of the AAT protein in your blood and lungs. It is not known if increasing AAT levels with GLASSIA affects worsening lung function or emphysema progression. Long-term effects of AAT therapy with GLASSIA have not been studied.
Please see full Indication and Limitations of Use below.

IMPORTANT SAFETY INFORMATION

What is the most important information I need to know about GLASSIA?

GLASSIA can cause severe allergic reactions including hives, swelling in the mouth or throat, itching, tightness in the chest, trouble breathing, wheezing, faintness or low blood pressure. See more safety info.

What is GLASSIA?

GLASSIA is a medicine containing human Alpha₁-Proteinase Inhibitor (Alpha₁-PI) that is used to treat adults with lung disease (emphysema) because of severe Alpha₁-antitrypsin (Alpha₁) deficiency. GLASSIA is not meant to be used as a therapy for lung disease other than severe Alpha₁ deficiency. Effects of GLASSIA on worsening lung function and emphysema progression have not been proven in clinical trials. Long-term effects of Alpha₁ replacement and maintenance therapy have not been studied.

IMPORTANT SAFETY INFORMATION

What is the most important information I need to know about GLASSIA?

GLASSIA can cause severe allergic reactions including hives, swelling in the mouth or throat, itching, tightness in the chest, trouble breathing, wheezing, faintness or low blood pressure
If you will be taking GLASSIA outside a healthcare setting, ask your healthcare provider (HCP) about an epinephrine pen and/or other supportive care for certain severe allergic reactions.

Who should not use GLASSIA?

Do not use GLASSIA if you:

Have immunoglobulin A (IgA) deficiency with antibodies to IgA
Have a severe allergic reaction to human Alpha₁-PI products.

What are the possible or reasonably likely side effects of GLASSIA?

If any of the following problems occur contact your healthcare provider (HCP) or call emergency services right away:

Worsening or flare-up of your chronic obstructive pulmonary disease (COPD)
Hives, swelling in the mouth or throat, itching, chest tightness, trouble breathing, wheezing, fainting or dizziness. These could be signs of a serious allergic reaction.

The most common side effects that may occur are headache and upper respiratory tract infections

Other possible side effects of GLASSIA include:

Cough
Sinus infection
Chest discomfort
Dizziness
Increased liver enzymes
Shortness of breath
Nausea
Fatigue

These are not all the possible side effects. Tell your HCP about any side effect that bothers you or that does not go away.

For additional safety information, click for Information For Patients including Instructions For Use and discuss with your HCP.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.