Well-Tolerated Therapy
Zemaira®. . . expect well-tolerated therapy.
Easy On You
In a 24-week, multicenter study of 30 patients with Alpha-1 and emphysema:
- Zemaira® was generally well tolerated
- Five treatment-related adverse events per 1,000 infusions were reported
- No serious treatment-related side effects were reported
In a separate analysis of the data after the study was completed, there was a lower
number of chronic obstructive pulmonary disease (COPD exacerbations.
Enhanced Viral Safety
Zemaira® is manufactured using advanced viral reduction technology.
This helps reduce the risk of viral contamination in your Alpha-1 therapy.
- Two highly effective virus reduction methods are designed to minimize the risk
of viral transmission—pasteurization* and dual ultrafiltration
- No evidence of viral transmission was seen in clinical studies with Zemaira®
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.