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Prolastin® is proven effective in the treatment of alpha1-antitrypsin (AAT) deficiency. Since 1988, patients have been treated with Prolastin®* and have achieved target levels in as little as 1 month.
Prolastin® is not a cure for AAT deficiency. However, it may help to slow the loss in 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.
*Clinical trials simultaneously meeting all 4 criteria—prospective, long term, controlled, and
randomized—have not been performed to evaluate the effect of chronic replacement therapy with Prolastin® on the regression or progression of emphysema in AAT deficiency. Prolastin
does not correct any underlying lung damage induced by AAT deficiency, but may retard the
progression of lung damage.
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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