Indications and Usage
Prolastin is indicated for the chronic replacement therapy of individuals having congenital alpha
1-antitrypsin deficiency with clinically demonstrable panacinar emphysema.
Prolastin is only indicated for use in patients with PiZZ, Piz(null), or Pi(null)(null) phenotypes.
Alpha1-Antitrypsin Deficiency Alpha
1-antitrypsin deficiency, also referred to as Alpha-1, is an inherited disorder that causes a significant reduction in the naturally occurring protein alpha
1-antitrypsin (AAT). Reduced levels of AAT result in the body being less able to protect itself from elastase, an enzyme in the white blood cells that normally helps to fight bacteria and that can cause damage to the air sacs in the lungs if not neutralized by AAT. AAT deficiency may predispose an individual to several serious illnesses, most commonly emphysema beginning in the third or fourth decade of life. Less frequently, AAT deficiency can result in liver disease, or a skin condition called panniculitis.
Important Safety Information Prolastin
®, (alpha1 Proteinase Inhibitor (Human), is indicated for chronic replacement therapy of individuals having congenital deficiency of alpha-1 PI (alpha-1 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.
Please click here for Prolastin
full prescribing information (PDF).
