References

  1. de Serres FJ. Alpha-1 antitrypsin deficiency is not a rare disease but a disease that is rarely diagnosed. Environ Health Perspect. 2003;111(16):1851-1854.
  2. de Serres FJ. Worldwide racial and ethnic distribution of α1-antitrypsin deficiency: summary of an analysis of published genetic epidemiologic surveys. Chest. 2002;122:1818-1829.
  3. Fairman P, Malhotra R. Alpha1-antitrypsin deficiency. eMedicine Pulmonology. http://emedicine.medscape.com/article/295686-overview. Accessed March 11, 2011.
  4. Alpha-1 Antitrypsin Deficiency: A Guide for the Recently Diagnosed Individual. Alpha-1 Foundation Web site. Available as a PDF (Select "Education Brochures #2") at: http://www.alpha-1foundation.org/publications. Accessed March 11, 2011.
  5. American Thoracic Society/European Respiratory Society statement: standards for the diagnosis and management of individuals with alpha-1 antitrypsin deficiency. Am J Respir Crit Care Med. 2003;168(7):818-900.
  6. Petrache I, Hajjar J, Campos M. Safety and efficacy of alpha-1-antitrypsin augmentation therapy in the treatment of patients with alpha-1-antitrypsin deficiency. Biologics Targets Ther. 2009;3:193-204.
  7. Alphas, friends & family—health tips. Alpha-1 Foundation Web site. Available at: http://www.alpha-1foundation.org/alphas/?c=13-Health-Tips. Accessed April 13, 2011.
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  9. Fregonese L, Stolk J. Hereditary alpha-1-antitrypsin deficiency and its clinical consequences. Orphanet J Rare Dis. 2008;3:16.
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  12. Stocks JM, Brantly M, Pollock D, et al. Multi-center study: the biochemical efficacy, safety and tolerability of a new α1-proteinase inhibitor, Zemaira. COPD. 2006;3(1): 17-23.
  13. Data on file, CSL Behring LLC.

Important Safety Information

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 appropriate for the following adult individuals as they may experience severe reactions, including anaphylaxis: individuals with a known hypersensitivity and/or history of anaphylaxis or severe systemic reaction to A1-PI products or their components, and individuals with selective IgA deficiencies who have known antibodies against IgA.

In clinical studies, the following treatment-related adverse reactions were reported in 1% of subjects: asthenia (fatigue), injection-site pain, dizziness, headache, paresthesia (tingling), and pruritus (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.

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.