GLASSIA
If you have emphysema due to alpha1-proteinase deficiency (also called AATD), GLASSIA may be an option. Manufactured by Kamada Ltd. and distributed by Baxter Healthcare Corporation, committed to AATD testing and patient support, GLASSIA is the first and only ready-to-use liquid AAT augmentation available in the United States.
GLASSIA is indicated for chronic augmentation and maintenance therapy in adults with emphysema due to congenital deficiency of alpha1-proteinase inhibitor (A1-PI), also known as alpha1-antitrypsin (AAT) deficiency. GLASSIA is not indicated as therapy for lung disease in patients in whom severe A1-PI deficiency has not been established. The effect of augmentation therapy with GLASSIA or any A1-PI product on pulmonary exacerbations and on the progression of emphysema in A1-PI deficiency has not been demonstrated in randomized, controlled clinical trials.1 Clinical data demonstrating the long-term effects of chronic augmentation and maintenance therapy of individuals with GLASSIA are not available.
Since GLASSIA comes in a ready to use liquid form:
- GLASSIA is administered without reconstitution (mixing)
- GLASSIA does not require the use of needles or a transfer device for reconstitution (mixing)
- GLASSIA requires fewer steps in the preparation process
GLASSIA [Alpha1-Proteinase Inhibitor (Human)]
GLASSIA is indicated for chronic augmentation and maintenance therapy in individuals with emphysema due to congenital deficiency of alpha1-proteinase inhibitor (Alpha1-PI), also known as alpha1-antitrypsin (AAT) 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 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.
Detailed Important Risk Information for GLASSIA
- GLASSIA is contraindicated in IgA deficient patients with antibodies against IgA. GLASSIA is contraindicated in individuals with a history of severe immediate hypersensitivity reactions, including anaphylaxis, to Alpha1-PI products.
- GLASSIA is made from human plasma. It may carry a risk of transmitting infectious agents, such as viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
- Administer GLASSIA at room temperature at a rate not greater than 0.04 mL/kg body weight per minute. If anaphylactic or severe anaphylactoid reactions occur, discontinue the infusion immediately.
- Administer GLASSIA within 3 hours of entering the vials.
- Safety and effectiveness in patients over 65 years of age have not been established.
- Two serious adverse reactions observed on two separate occasions during clinical studies with GLASSIA were cholangitis and exacerbation of chronic obstructive pulmonary disease (COPD).
- The most common product-related adverse reactions in clinical studies were headache and dizziness.
Please see GLASSIA Full Prescribing Information for full prescribing details.
References
- GLASSIA [Alpha1-Proteinase Inhibitor (Human)] Prescribing Information. August 2010.
