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Liver Disease

Liver disease is the second most frequent medical problem of alpha1-antitrypsin (AAT) deficiency. When less AAT is released from the liver to the bloodstream, increased amounts of AAT remain in the liver; this can produce liver disease. When liver disease develops, it usually manifests itself in infants as jaundice and hepatitis. However, liver disease may also develop in children and adults as cirrhosis. In fact, liver disease typically presents as cirrhosis or carcinoma of the liver in at least 25% of AAT-deficient adults over the age of 50 years. Rarely, patients may develop significant lung disease and liver disease at the same time.

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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