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Genetic Testing Protected from Discrimination

With the signing of the Genetic Information Nondiscrimination Act (GINA) into law*, we've hit a new milestone in patients' rights. Genetic testing can lead to early detection and allow for early treatment of a host of hereditary conditions, but patients have been cautious about how health insurance companies or future employers might use that information. GINA helps reduce those concerns.

Specifically, GINA prohibits insurance companies and employers from discriminating against you based on:

  • genetic information
  • the refusal to produce genetic information
  • the refusal to submit to genetic testing
  • having been genetically tested in the past

What does this specifically mean to the alpha-1 community? It allows early detection of AATD without fear of employment or insurance consequences. Since AATD is a genetic disease, all family members can be tested and the appropriate lifestyle changes can be made.

*The GINA Bill has passed through the U.S. Senate on April 24, 2008 and the U.S. House of Representatives on May 1, 2008. The bill was signed into law by President George W. Bush on May 21, 2008. The health insurance components take effect on May 21, 2009, and the employment components take effect on November 21, 2009.

ARALAST NP [Alpha1–Proteinase Inhibitor (Human)] Approved by the FDA

We are pleased to announce the arrival of ARALAST NP that has been approved by the FDA.

ARALAST NP is similar to ARALAST, with the identical anti-neutrophil elastase activity, indication, and dosing. Please see the Prescribing Information for ARALAST NP that includes pharmacokinetic (PK) data.

ARALAST is processed externally, whereas ARALAST NP is processed entirely within Baxter facilities. The FDA required a name change to distinguish the two products, and Baxter chose to add a suffix rather than change the entire name, given that the products are similar and the ARALAST name is known and familiar to you and your patients.

Your patients will continue to receive their infusions exactly the way they are receiving them now with no lapse during the transition period. Once they have received their first dose of ARALAST NP, they will no longer receive ARALAST.

We are committed to making this transition from ARALAST to ARALAST NP convenient for you and your patients, and we assure you that you can expect the same quality of product and service that Baxter has provided to you with ARALAST.

We understand that you may have questions or concerns, and we encourage you to call Baxter BioScience Global Medical Affairs through our toll-free number (866-424-6724).

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ARALAST NP [Alpha1-Proteinase Inhibitor (Human)]

ARALAST NP is indicated for chronic augmentation therapy in patients having congenital deficiency of A1-PI with clinically evident emphysema. ARALAST NP is not indicated as therapy for lung disease patients in whom congenital A1-PI deficiency has not been established.

Important Safety Information

  • ARALAST NP is contraindicated in individuals with selective IgA deficiencies (IgA level less than 15 mg/dL) who have known antibody against IgA, since they may experience severe reactions, including anaphylaxis to IgA, which may be present in small quantities in the final drug product.
  • ARALAST NP is derived from pooled human plasma. It may carry a risk of transmitting infectious agents, e.g. viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
  • The most common adverse events deemed related to ARALAST NP included: headache (4 of 61 [7%] events) and musculoskeletal discomfort (4 of 61 [7%] events).

Please review the Important Safety Information and the Full Prescribing Information

ARALAST [Alpha1-Proteinase Inhibitor (Human)]

ARALAST is indicated for chronic augmentation therapy in patients having congenital deficiency of A1-PI with clinically evident emphysema. ARALAST is not indicated as therapy for lung disease patients in whom congenital A1-PI deficiency has not been established.

Important Safety Information

  • 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 a severe, potentially life-threatening allergic reaction to IgA, which may be present.
  • ARALAST is made from human plasma. It may carry a risk of transmitting infectious agents, e.g. viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
  • The most common symptoms during the clinical study were headache (0.3%) and sleepiness (0.3%). Post market adverse event data have indicated reports of infusion site pain associated with the administration of ARALAST.
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