Newly Diagnosed With Alpha-1?
Alpha1-proteinase inhibitor deficiency (Alpha-1), also known as
alpha1-antitrypsin deficiency (AATD), is a shortage or absence of
a protein that blocks the destructive effects of certain enzymes. It is a genetic
disorder that can lead to the destruction of lung tissue and can cause chronic
lung disease and liver disease.1
Receiving a diagnosis of Alpha-1 can be disturbing and confusing. As with
other chronic health conditions, it’s good to know that you are not alone.
Living with Alpha-1 provides more
information to help you manage Alpha-1.
What is Augmentation Therapy? will help you
to understand your treatment options. To learn about augmentation therapy with
Zemaira, see About 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.
- National Heart, Lung, and Blood Institute Diseases and Conditions Index: COPD. What is Chronic Obstructive Pulmonary Disease (COPD)? Available at:
http://www.nhlbi.nih.gov/health/dci/Diseases/Copd/Copd_WhatIs.html. Accessed March 27, 2004.