PROLASTIN SUMMARY
Alpha1-Proteinase Inhibitor (Human), Prolastin® is a sterile, stable, lyophilized preparation of purified human Alpha1-Proteinase Inhibitor (alpha1-PI), also known as alpha1-antitrypsin. Prolastin is intended for use in therapy of congenital alpha1-antitrypsin deficiency.
Alpha1-Proteinase Inhibitor (Human), Prolastin® is indicated for chronic replacement therapy of individuals having congenital deficiency of alpha1-PI (alpha1-antitrypsin deficiency) with clinically demonstrable panacinar emphysema. Clinical and biochemical studies have demonstrated that with such therapy, it is possible to increase plasma levels of alpha1-PI, and that levels of functionally active alpha1-PI in the lung epithelial lining fluid are increased proportionately. 18-20 As some individuals with alpha1-antitrypsin deficiency will not go on to develop panacinar emphysema, only those with evidence of such disease should be considered for chronic replacement therapy with Prolastin. 22 Subjects with the PiMZ or PiMS phenotypes of alpha1-antitrypsin deficiency should not be considered for such treatment as they appear to be at small risk for panacinar emphysema. 22 Clinical data are not available as to the long-term effects derived from chronic replacement therapy of individuals with alpha1-antitrypsin deficiency with Prolastin. Only adult subjects have received Prolastin to date.
Prolastin is not indicated for use in patients other than those with PiZZ, PiZ(null) or Pi(null)(null) phenotypes.
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