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Important Safety Information
Prolastin, Alpha1-Proteinase Inhibitor (Human) is indicated for
the augmentation and maintenance
therapy of individuals having congenital deficiency of alpha-1 PI (alpha1 -antitrypsin deficiency) with clinically demonstrable panacinar emphysema.
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%).
Prolastin is made from human plasma. As with all plasma-derived therapeutics, the potential to transmit infectious agents, such as viruses and theoretically, the Creutzfeldt-Jakob (CJD) agent that can cause disease, cannot be totally eliminated. There is also the possibility that unknown infectious agents may be present in such products.
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 speak to your doctor and refer to Prolastin Prescribing Information for full details.
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.
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