Alpha-1 deficiency is a genetic condition characterized by low levels of alpha1 antitrypsin, a protein that protects the lungs from an enzyme called neutrophil elastase. The primary function of neutrophil elastase is to rid the lungs of germs and old or damaged cells. However, if it is not properly regulated, neutrophil elastase can attack healthy lung tissue.
People with Alpha-1 deficiency have levels of alpha-1 antitrypsin below protective thresholds and are susceptible to related emphysema and lung disease.
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Important Safety Information for Zemaira
Alpha1-Proteinase Inhibitor (Human), Zemaira® is indicated for chronic augmentation and maintenance therapy for adults with alpha1-proteinase inhibitor (A1-PI) deficiency and emphysema. Clinical data demonstrating the long-term effects of chronic augmentation therapy with Zemaira are not available.
Zemaira may not be suitable for everyone; for example, people with known hypersensitivity to components used to make Zemaira, those with a history of anaphylaxis or severe systemic response to A1-PI products, and those with certain IgA deficiencies. If you think any of these may apply to you, ask your doctor.
In clinical studies, the following adverse reactions were reported in 1% of subjects: fatigue, injection-site pain, dizziness, headache, tingling, and itching.
Zemaira is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.
Please see full prescribing information for Zemaira.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.