Alpha-1 Information

What is Alpha-1?

Alpha-1 is a genetic condition caused by a lack 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 and cause damage.1

  • People who do not make enough alpha1 antitrypsin have a condition known as Alpha-1 and are susceptible to lung disease1
  • Alpha-1–associated emphysema can become chronic and weaken your lungs1

Alpha1 Antitrypsin in Action

Watch a video animation that shows the critical role of alpha1 antitrypsin in the lungs

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Symptoms

Symptoms of Alpha-1 are often misdiagnosed as chronic obstructive pulmonary disease (COPD), chronic bronchitis, or asthma and typically include2,3,4

  • Shortness of breath
  • Persistent cough
  • Wheezing
  • Excessive sputum production
Cigarette smoking has been shown to accelerate the onset of Alpha-1 symptoms by approximately 10 years.2

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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