PROLASTIN-C is indicated for chronic augmentation and maintenance therapy in adults with emphysema due to deficiency of alpha1-proteinase inhibitor (AAT deficiency). AAT deficiency is a genetic condition in which low levels of the alpha1-protein can result in emphysema. The active protein in PROLASTIN-C increases or "augments" protein levels in AAT deficient patients. PROLASTIN-C has replaced PROLASTIN in the US and Canada.
Important Safety Information for PROLASTIN-C and PROLASTIN
PROLASTIN and PROLASTIN-C, Alpha1-Proteinase Inhibitor (Human), are indicated for chronic augmentation and maintenance therapy in adults with emphysema due to deficiency of alpha-1 PI (alpha1-antitrypsin deficiency). The effect of augmentation therapy with any alpha 1-proteinase inhibitor (alpha 1-PI) on pulmonary exacerbations and on the progression of emphysema in alpha 1-antitrypsin deficiency has not been demonstrated in randomized, controlled clinical trials.
PROLASTIN and 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. Both PROLASTIN and PROLASTIN-C are contraindicated in patients with antibodies a
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