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.

As with other Alpha-1 therapies, 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. As with all plasma-derived products, the risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.

For more information about Zemaira^®, please see the 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.