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Grifols study demonstrates higher dose of PROLASTIN-C increases levels of alpha1-PI to within normal range in patients with AAT deficiency
Date:5/22/2013

n>North America and Europe combined, although greater than 90% of individuals remain undiagnosed.

About PROLASTIN® and PROLASTIN®-C

PROLASTIN and PROLASTIN-C are indicated for the treatment of alpha1-antitrypsin (AAT) deficiency in patients with emphysema.  AAT deficiency is a genetic condition in which low levels of the alpha1 protein can result in emphysema in adults and liver disease primarily in children. The active protein in PROLASTIN and PROLASTIN-C increases or augments protein levels in AAT-deficient patients. PROLASTIN is approved or registered in select countries in Europe and South America while PROLASTIN-C is approved in the US, Canada, Argentina and Colombia.

Important Safety Information about PROLASTIN®-C

PROLASTIN-C, Alpha1-Proteinase Inhibitor (Human) is indicated for chronic augmentation and maintenance therapy in adults with emphysema due to deficiency of alpha1-proteinase inhibitor (alpha1-antitrypsin deficiency).

The effect of augmentation therapy with any alpha1-proteinase inhibitor (alpha1-PI) on pulmonary exacerbations and on the progression of emphysema in alpha1-antitrypsin deficiency has not been demonstrated in randomized, controlled clinical trials. PROLASTIN-C is not indicated as therapy for lung disease in patients in whom severe Alpha1-PI deficiency has not been established.

PROLASTIN-C may contain trace amounts of IgA. Patients with known antibodies to IgA, which can be present in patients with selective or severe IgA deficiency, have a greater risk of developing potentially severe hypersensitivity and anaphylactic reactions. PROLASTIN-C is contraindicated in patients with an
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