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![Prolastin® (alpha-1 proteinase inhibitor [human]) bottles and package.](images/prolastin_product_hcp.jpg "Prolastin® (alpha-1 proteinase inhibitor [human]) bottles and package.") |
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Prolastin®, derived from human plasma, is a concentrated form of alpha1 antitrypsin (AAT). Since 1988, Prolastin® has been proven to raise the AAT blood and lung levels in patients with AAT deficiency. 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. |
Prolastin® is not a cure for AAT. However, it may help to slow the loss of lung function that characterizes this disease. Prolastin® is only approved for chronic replacement therapy in individuals with emphysema due to congenital AAT deficiency and is not approved for the treatment of emphysema due to other causes, such as smoking. Prolastin® is not indicated for use in patients other than those with PiZZ, PiZ(null), or Pi(null)(null) phenotypes. In addition, Prolastin® cannot be used to treat individuals with liver disease due to AAT deficiency.
Prolastin® alpha1-proteinase inhibitor (human) is a sterile, stable, lyophilized preparation of purified human AAT.1 Prolastin® is prepared from pooled human plasma of healthy donors by a modification of the cold ethanol fractionation procedure originally described by Cohn.2, 3
Prolastin® contains small amounts of other plasma proteins including alpha2-antiplasmin, alpha1-antichymotrypsin, C1-esterase inhibitor, haptoglobin, antithrombin, alpha1-lipoprotein, albumin, and IgA.
Prolastin® is packaged in vials containing approximately 500 mg or 1000 mg of functionally active AAT. The functional activity of Prolastin® is determined by the capacity of AAT to neutralize porcine pancreatic elastase.
References:
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Talecris Biotherapeutics. Prolastin® Package Insert.
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Cohn EJ, Strong LE, Hughes WL, et al. Preparation and properties of serum and plasma proteins. IV. A system for the separation into fractions of the protein and lipoprotein components of biological tissues and fluids. J Am Chem Soc. 1946;68:459-75.
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Cohn EJ, Gurd FRN, Surgenor DM, et al. A system for the separation of the components of human blood: Quantitative procedures for the separation of the protein components of human plasma. J Am Chem Soc. 1950;72:465-474.
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Important Safety Information
Prolastin®, Alpha1-Proteinase Inhibitor (Human) is indicated for chronic replacement therapy of individuals having congenital deficiency of alpha-1 PI (alpha1-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.
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.
Please click here for Prolastin® full Prescribing Information.
Remember, your doctor or healthcare provider is the single best source of information regarding you and your health. Please consult your doctor or healthcare provider if you have any questions about your health or any of your medications.
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