References

  1. Alpha-1 Foundation. What is Alpha-1? http://alpha-1foundation.org/what-is-alpha-1/. Accessed May 8, 2014.
  2. 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.
  3. 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.
  4. Stoller JK, Aboussouan LS. A review of α1-antitrypsin deficiency. Am J Respir Crit Care Med. 2012;185(3):246-259.
  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. Stoller JK, Brantly M. The challenge of detecting alpha-1 antitrypsin deficiency. COPD. 2013;10(suppl 1):26-34.
  7. Alpha-1 Association. https://www.alpha1.org/newly-diagnosed/living-with-alpha-1. Accessed May 8, 2014.
  8. American Heart Association website. Physical activity improves quality of life. http://www.heart.org/HEARTORG/HealthyLiving/PhysicalActivity/StartWalking/Physical-activity-improves-quality-of-life_UCM_307977_Article.jsp#Vx5mtyMrJuU. Accessed April 26, 2016.
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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.

CSL Behring

Zemaira is manufactured and distributed by CSL Behring LLC.
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© 2017 CSL Behring. The product information presented on this site is intended for US residents only.
ZMR14-04-0006d(1) 5/2015