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Glassia Generic Name & Formulations
Legal Class
Rx
General Description
Alpha1-proteinase inhibitor (human) 1g/vial; soln for IV infusion; preservative- and latex-free.
How Supplied
Single-use vial (50mL)—1 (w. a filter needle)
Manufacturer
Generic Availability
NO
Glassia Indications
Indications
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.
Glassia Dosage and Administration
Adult
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.
Children
Not established.
Glassia Contraindications
Contraindications
IgA deficient patients with antibodies against IgA.
Glassia Boxed Warnings
Not Applicable
Glassia Warnings/Precautions
Warnings/Precautions
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.
Glassia Pharmacokinetics
See Literature
Glassia Interactions
Not Applicable
Glassia Adverse Reactions
Adverse Reactions
Headache, upper respiratory tract infection, cough, sinusitis, chest discomfort, dizziness, hepatic enzyme increased.
Glassia Clinical Trials
See Literature
Glassia Note
Not Applicable
Glassia Patient Counseling
See Literature
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