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Proven Efficacy
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Prolastin is effective in the treatment of alpha1-antitrypsin (AAT) deficiency |
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Raises AAT levels without compromising safety |
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| Markedly increased patients’ levels of AAT1 |
Slower-than-expected long-term decline in FEV12 |
| Trial of 21 patients with AAT deficiency, evaluated before treatment and weekly for up to 6 months during therapy with an alpha1-proteinase inhibitor (Cutter Biological). An additional 9 normal subjects served as controls, with an average serum AAT level of 220 mg/dL. |
Uncontrolled, prospective study of 20 patients with severe AAT deficiency followed during 36 months with alpha1-proteinase inhibitor. Expected decline in FEV1 in patients with nonaugmented AAT deficiency may range from 40 to 316 mL/year (120 to 948 mL/36 months).2 |
| Over a 1-month period, treated patients averaged AAT levels within normal range (163 ± 4 mg/dL)1 |
Prolastin® significantly delayed the decline in FEV1 among patients with baseline FEV1 35% to 49% predicted (P=0.03)3 |
Significantly Higher Survival Rates With Prolastin®3†
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Overall mortality risk significantly lower for Prolastin® alpha1-proteinase inhibitor (human) recipients than for nonrecipients
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Risk ratio = 0.64:1, recipients vs nonrecipients, P=0.02
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Mortality risk especially reduced among patients with baseline FEV1 35% to 49% predicted
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Risk ratio = 0.21:1, recipients vs nonrecipients, P<0.001 |
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†In patients with baseline FEV1 <50% predicted.
| 1. |
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Wewers MD, Casolaro MA, Sellers SE, et al. Replacement therapy for alpha1-antitrypsin deficiency associated with emphysema. N Engl J Med. 1987;316:1055-1062. |
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Schwaiblmair M,Vogelmeier C, Fruhmann G. Long-term augmentation therapy in twenty patients with severe alpha-1-antitrypsin deficiency — three-year follow-up. Respiration. 1997;64:10-15. |
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Survival and FEV1 decline in individuals with severe deficiency of α1-antitrypsin.The Alpha-1-Antitrypsin Deficiency Registry Study Group. Am J Respir Crit Care Med. 1998;158:49-59. |
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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