Alpha1-antitrypsin deficiency, also referred to as Alpha-1, is an inherited disorder that causes a significant reduction in the naturally occurring protein alpha1-antitrypsin (AAT). Reduced levels of AAT result in the body being less able to protect itself from elastase, an enzyme in the white blood cells that normally helps to fight bacteria and that can cause damage to the air sacs in the lungs if not neutralized by AAT. AAT deficiency may predispose an individual to several serious illnesses, most commonly emphysema beginning in the third or fourth decade of life. Less frequently, AAT deficiency can result in liver disease, or a skin condition called panniculitis.
It is believed that AAT deficiency affects as many as 200,000 people in North America and Europe. AAT deficiency is most common among Caucasians of Northern European descent. It is estimated that as many as 95% of people with alpha1-antitrypsin deficiency have not been identified.
There are many components to treating AAT. There is a specific pharmacologic treatment that helps restore, through replacement therapy, the natural balance of enzymes in the lungs, protecting them from the damage caused by neutrophil elastase. For 15 years, our proteinase inhibitor product, Prolastin®, Alpha1-Proteinase Inhibitor (Human), was the only augmentation therapy available for persons suffering from alpha-1 antitrypsin (ATT) deficiency.
Prolastin®, Alpha1-Proteinase Inhibitor (Human), derived from human plasma, is a concentrated form of AAT. Given as prescribed, Prolastin raises the blood and lung levels of AAT. This may help lessen damage to the lungs caused by the enzymatic activity of neutrophil elastase. Because Prolastin therapy augments or replaces AAT, it is known as "augmentation" or "replacement" therapy.
The most commonly reported side effects with Prolastin®, Alpha1-Proteinase Inhibitor (Human) are delayed fever, light-headedness, and dizziness.
Prolastin®, Alpha1-Proteinase Inhibitor (Human) is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, that can cause disease. The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and/or removing certain viruses. Despite these measures, such products can still potentially transmit disease. There is also the possibility that unknown infectious agents may be present in such products. Individuals who receive infusions of blood or plasma products may develop signs and/or symptoms of some viral infections, particularly hepatitis C.
The products discussed herein may have different product labeling in different countries. For information about Talecris Biotherapeutics' AAT product, including full prescribing information, please select your country of residence:
Important Safety Information
Prolastin®, Alpha1-Proteinase Inhibitor (Human), is indicated for chronic replacement therapy of individuals having congenital deficiency of alpha-1 PI (alpha-1 antitrypsin deficiency) with clinically demonstrable panacinar emphysema.
Weekly Prolastin therapy has demonstrated a low occurrence of side effects. In clinical studies with Prolastin, reactions were observed in 1.16% of infusions, the most common events being fever (0.77%), light-headedness (0.19%), and dizziness (0.19%). As with all plasma-derived therapeutics, the potential to transmit infectious agents cannot be totally eliminated. Individuals with selective IgA deficiencies who have known antibody against IgA (anti-IgA antibody) should not receive Prolastin, since these patients may experience severe reactions, including anaphylaxis, to IgA which may be present.
US residents please click here for Prolastin full prescribing information (PDF).
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