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.