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. No clinical data are available demonstrating the effect of augmentation therapy with Zemaira or any A1-PI product on the progression of emphysema in A1-PI deficiency.
Zemaira is not indicated for lung disease patients in whom severe A1-PI deficiency has not been established.
Zemaira is contraindicated in patients with a history of severe systemic reactions to the product or to A1-PI protein, including anaphylaxis. Due to the risk of severe hypersensitivity, Zemaira is also contraindicated in immunoglobulin A-deficient patients with antibodies against IgA.
Use caution in administering Zemaira to patients who have experienced anaphylaxis or severe systemic reactions to another A1-PI product. Patients with selective or severe IgA deficiency can develop antibodies to IgA and are at greater risk of such reactions. If anaphylactic or severe anaphylactoid reactions occur during infusion, discontinue immediately.
In clinical studies, the following adverse reactions were reported in at least 5% of subjects receiving Zemaira: headache, sinusitis, upper respiratory infection, bronchitis, asthenia, increased cough, fever, injection-site hemorrhage, rhinitis, sore throat, and vasodilation.
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 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.