GLASSIA

NEW Reimbursement Code for GLASSIA

As of January 1, 2012, the reimbursement code for GLASSIA has changed to: J0257, INJECTION, ALPHA 1-PROTEINASE INHIBITOR (HUMAN), (GLASSIA), 10 MG.
Be sure your practice uses this new code for quick and accurate reimbursement.

GLASSIA is the only ready-to-use liquid AAT augmentation for AATD. GLASSIA is indicated for chronic augmentation and maintenance therapy in individuals with emphysema due to congenital deficiency of alpha₁-proteinase inhibitor (A₁-PI), also known as alpha-1 antitrypsin (AAT) deficiency.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
GLASSIA does not require the use of needles or a transfer device for reconstitution
GLASSIA requires fewer steps in the preparation process

GLASSIA contains no preservatives.

Selected 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 severed immediate hypersensitivity reactions, including anaphylaxis, to Alpha₁-PI products.

Clinical Results¹

Augments A₁-PI levels in the blood and lungs
In a phase II,III study, GLASSIA was shown to be non-inferior to the comparator A₁-PI product

GLASSIA is manufactured by Kamada Ltd. and distributed by Baxter, a global leader in innovative healthcare products and comprehensive patient support programs. GLASSIA provides another AAT augmentation option.

Infusion in the Home

Based on patient clinical needs and convenience, GLASSIA can be infused at home. Baxter distributes GLASSIA through a number of highly specialized homecare companies that will work with your patients to provide comprehensive care and support. They include: Accredo, BioRx, Caremark, Coram, CuraScript SP, US Bioservices and Walgreens.

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.

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)] [package insert]. Westlake Village, CA: Baxter Healthcare; August 2010.