Generic Name and Formulations:
Alpha1-proteinase inhibitor (human) 1g/vial; soln for IV infusion; preservative- and latex-free.
Shire US, Inc.
Indications for GLASSIA:
For chronic augmentation and maintenance therapy in adults with clinical evidence of emphysema due to severe alpha1-proteinase inhibitor (Alpha1-PI) deficiency.
Limitations Of use:
Effect of augmentation therapy on pulmonary exacerbations and progression of emphysema in Alpha1-PI deficiency has not been conclusively demonstrated in clinical trials. Data demonstrating the long-term effects of chronic augmentation and maintenance therapy are not available. Not for treating lung disease in patients whom severe Alpha1-PI deficiency has not been established.
Should be administered by healthcare provider or self-administered at home after appropriate training. Give by IV infusion at a max rate of 0.2mL/kg/min. 60mg/kg once weekly. Monitor the infusion rate closely during administration and for signs of infusion-related reactions.
IgA deficient patients with antibodies against IgA.
Have epinephrine and/or other supportive therapy available. Discontinue if hypersensitivity reactions occur and treat appropriately. Contains human plasma; monitor for possible infection transmission (eg, viruses, Creutzfeldt-Jakob disease agent). Pregnancy. Nursing mothers.
Headache, upper respiratory tract infection, cough, sinusitis, chest discomfort, dizziness, hepatic enzyme increased.
Single-use vial (50mL)—1 (w. a filter needle)