educating healthcare professionals and advancing public policy for the Alpha-1 Community.” 
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One Baxter Parkway Deerfield, IL. 60015 Baxter January 14, 2005 Dear Healthcare Professional: On January 11, 2005, the Alpha-1 Foundation sent a communication to physicians and patients regarding the isoelectric point profile and safety of ARALAST brand of Alpha 1-Proteinase Inhibitor (Human). In response, we would like to address misconceptions in the letter and make sure you have the necessary information about ARALAST that you can use in answering questions you may receive from patients. First and foremost, ARALAST is a safe and effective product indicated for chronic augmentation therapy in adults with congenital deficiency of alpha-1 proteinase inhibitor with clinically evident emphysema. A clinical study was conducted with ARALAST comparing it to another currently available therapy, Prolastin. This pivotal, clinical and biochemical study demonstrated that with such therapy, ARALAST is effective in maintaining target serum alpha-1 proteinase inhibitor trough levels. The Alpha-1 Foundation letter refers to a "modification" with ARALAST and suggests that it may result in health risks. However, there have been no changes to the product or its safety profile and the ARALAST that is available today is the same product that was approved by the U.S. Food and Drug Administration in December 2002. It is important to note that there have been more than 7,000 infusions of ARALAST to date during which time no serious adverse events were reported to Baxter. In addition, our post-marketing experience with the product continues to be consistent with the results shown in clinical trials. If you would like additional information about ARALAST, please contact our Medical Affairs Department at 866-4-BIOSCI (866-424-6724). Regards,  David Gelmont, M.D. Global Medical Director, Pulmonary and Critical Care Therapeutic Area Please refer to Important Safety Information on the next page. |
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Baxter Important Safety Information: ARALAST is not indicated in therapy for lung disease patients in whom alpha-1 proteinase inhibitor deficiency has not been established. ARALAST is contraindicated in individuals with selective IgA deficiencies (IgA level less than 15mg/dL) who have known antibody against IgA, since they may experience severe reactions, including anaphylaxis, to IgA, which may be present. The most common symptoms during the clinical study were headache (0.3%) and somnolence (0.3%). Post market adverse event data have indicated reports of infusion site pain associated with the administration of ARALAST. Pregnancy Category C, reproduction studies have not been conducted with ARALAST. As with all plasma-derived therapeutics, the potential to transmit infectious agents cannot be totally eliminated. For more information regarding peer-reviewed, published data on the safety and efficacy of ARALAST, please refer to the following journal articles: Stoller JK, Rouhani F, Brantly M, et al. Biochemical efficacy and safety of a new pooled human plasma alpha-1 antitrypsin, Respitin. Chest 2002; 122:66-74. Juvelekian GS, Stoller JK. Augmentation Therapy for Alpha-1 Antitrypsin Deficiency. Drugs 2004:64 (16): 1743-1756. BAXTER and ARALAST are trademarks of Baxter International Inc. PROLASTIN is a trademark of Bayer Corporation. Please see enclosed ARALAST full prescribing information. Please Click HERE for: Complete "AralastTM" Prescribing Information |
For more information about Baxter, please visit www.aralast.com
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