REFERENCES

  1. Alpha-1 Foundation website. What is Alpha-1? http://alpha-1foundation.org/what-is-alpha-1. Accessed December 17, 2014.
  2. 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.
  3. Campos MA, Wanner A, Zhang G, Sandhaus RA, Trends in the diagnosis of symptomatic patients with a1-antitrypsin deficiency between 1968 and 2003. Chest. 2005; 128(3); 1179-1186.
  4. Alpha-1 Foundation website. Family testing. http://alpha-1foundation.org/its-all-in-the-family/. Accessed December 17, 2014.
  5. Stocks JM, Brantly M, Pollock D, et al. Multi-center study: the biochemical efficacy, safety and tolerability of a new a1-proteinase inhibitor, Zemaira. COPD. 2006;3(1):17-23.
  6. 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.
  7. Data on file. Available from CSL Behring as DOF ZMR-001.
  8. Fregonese L, Stolk J. Hereditary alpha-1-antitrypsin deficiency and its clinical consequences. Orphanet J Rare Dis. 2008;3:16.
  9. Alpha-1 Foundation website. What is Alpha-1? http://www.alpha1.org/newly-diagnosed/what-is-alpha-1. December 19, 2014.
  10. American Lung Association website. Understanding Cystic Fibrosis. http://www.lung.org/lung-disease/cystic-fibrosis/understanding-cystic-fibrosis.html. Accessed December 17, 2014.
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Important Safety Information

Alpha1-Proteinase Inhibitor (Human), Zemaira® is indicated to raise the plasma level of alpha1-proteinase inhibitor (A1-PI) in patients with A1-PI deficiency and related emphysema. The effect of this raised level on the frequency of pulmonary exacerbations and the progression of emphysema have not been established in clinical trials.

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.

Early signs of hypersensitivity reactions to Zemaira include hives, rash, tightness of the chest, unusual breathing difficulty, wheezing, and feeling faint. Immediately discontinue use and consult with physician if such symptoms occur.

In clinical studies, the following adverse reactions were reported in at least 5% of subjects receiving Zemaira: headache, sinusitis, upper respiratory infection, bronchitis, fatigue, increased cough, fever, injection-site bleeding, nasal symptoms, sore throat, and swelled blood vessels.

Because Zemaira is made from human blood, the risk of transmitting 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.

Zemaira is manufactured and distributed by CSL Behring LLC.
Zemaira® and CareZ® are registered trademarks of CSL Behring LLC.

© 2017 CSL Behring LLC. The product information presented on this site is intended for US residents only. ZMR03-13-0022(3) 6/2015