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. Fairman P, Malhotra R. Alpha1-antitrypsin deficiency. eMedicine Pulmonology. http://emedicine.medscape.com/article/295686-overview. Accessed March 11, 2011.
  3. Rachelefsky G, Hogarth DK. Issues in the diagnosis of α1-antitrypsin deficiency. J Allergy Clin Immunol. 2008;121(4):833-838.
  4. Silverman EK, Sandhaus RA. Alpha1-antitrypsin deficiency. N Engl J Med. 2009;360(26):2749-2757.
  5. de Serres FJ, Blanco I, Fernandez-Bustillo E. Ethnic differences in alpha-1 antitrypsin deficiency in the United States of America. Ther Adv Respir Dis. 2010;4(2):63-70.
  6. 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.
  7. Crystal RG. A1-antitrypsin deficiency, emphysema, and liver disease. J Clin Invest. 1990:85(5):1343-1352.
  8. Alpha-1 Foundation. Alpha-1 Antitrypsin Deficiency: A Guide for the Recently Diagnosed Individual. Version 1.7. Miami, FL: Alpha-1 Foundation; 2006.
  9. 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.
  10. 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.
  11. Pulmonary function tests. MedlinePlus website. Available at: http://www.nlm.nih.gov/medlineplus/ency/article/003853.htm. Accessed March 15, 2011.
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  14. 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.

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.

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