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Important Safety Information for Zemaira

Alpha1-Proteinase Inhibitor (Human), 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 pre-licensure 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 and its variant (vCJD), cannot be completely eliminated.

Indications

ZEMAIRA is indicated for chronic augmentation and maintenance therapy for adults with alpha1-proteinase inhibitor (A1-PI) deficiency and emphysema. The effect of augmentation therapy with ZEMAIRA or any A1-PI product on pulmonary exacerbations and progression of emphysema in A1-PI deficiency has not been demonstrated in randomized, controlled clinical studies.

ZEMAIRA is not indicated for lung disease patients in whom severe A1-PI deficiency has not been established.

Please see full prescribing information for ZEMAIRA.

To report SUSPECTED ADVERSE REACTIONS, contact the CSL Behring Pharmacovigilance Department at 1-866-915-6958 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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