How is GLASSIA administered?
The recommended dosage of GLASSIA is 60 mg/kg body weight administered once weekly by intravenous infusion. The infusion rate should not exceed 0.04 mL/kg body weight per minute and should be closely followed and vital signs monitored continuously. If anaphylactic or severe anaphylactoid reactions occur, discontinue the infusion immediately. Administer GLASSIA within 3 hours of entering the vials.
How often is GLASSIA administered?
GLASSIA is prescribed for infusion once per week.1 Of course, you should also continue to see your physician regularly so that he or she can watch and treat any symptoms related to emphysema.Where is GLASSIA administered?
Based on patient clinical needs and convenience, GLASSIA can be infused at home, infusion centers and hospitals. Baxter distributes GLASSIA through a number of highly specialized homecare companies that will work with you to provide comprehensive care and support. They include: Accredo, BioRx, Caremark, Coram, CuraScript SP, US Bioservices and Walgreens.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.
