Treating Alpha-1
Goals of treatment
Because Alpha-1 is caused by a deficiency of the protein alpha1 antitrypsin1—and
made worse by exposure to smoking, dust, and other irritants that cause inflammation1,2—there
are 3 strategies for managing Alpha-1:
- Decrease the patient's exposure to these proinflammatory stimuli1,2
- Replace or augment the patient's missing alpha1 antitrypsin protein1,3
- Incorporate short-acting bronchodilators or inhaled corticosteroids to provide patients
with temporary symptom relief1
The major focus of treatment of patients with emphysema due to severe alpha1 antitrypsin deficiency
has been to correct the deficiency of the alpha1 antitrypsin protein with augmentation
therapy.3 The hypothesis that augmentation therapy will prevent further lung damage
has not been tested in an adequately powered, randomized, controlled clinical trial.
Alpha1 Antitrypsin Augmentation Therapy
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.