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Prolastin® is a concentrated form of alpha1-antitrypsin
(AAT) that is derived from human plasma-the fluid part of the blood. Given as prescribed,
Prolastin® raises the levels of AAT in the blood and lungs. Raising
the AAT level may help reduce the damage to the lungs caused by destructive enzymes. Because
Prolastin® "augments" or replaces missing AAT, it is referred
to as "augmentation" or "replacement" therapy. It's important to know that
Prolastin® is not a cure for
AAT deficiency. However, it may help to slow the loss in lung function caused by the disease. Also,
Prolastin® is approved only for chronic, or ongoing,
replacement therapy in people with emphysema caused by genetic AAT deficiency.
How Is Prolastin® Given?
A healthcare professional (usually a nurse) administers Prolastin® to patients intravenously (through a vein) with a needle once a week.
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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