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Genetic Testing Protected from Discrimination
With the signing of the Genetic Information Nondiscrimination Act (GINA) into law, patients' rights have hit a new milestone.* Learn more
ARALAST NP [Alpha1-Proteinase Inhibitor (Human)]
We are pleased to announce ARALAST NP and its approval by the FDA. Learn More
*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 [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.
Please see ARALAST Full Prescribing Information
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).
The pharmacokinetic profile of ARARLAST NP was compared to ARALAST through a multicenter, single-dose, randomized, double-blind clinical study. Treatment-related adverse events were reported in 8 of 25 subjects (32%) for ARALAST NP and 7 of 25 subjects (28%) in ARALAST. Results showed that plasma A1-PI concentration levels were statistically similar for both therapies. Adverse events for both therapies were similar.
Please see ARALAST NP Full Prescribing Information.
- Alpha-1 antitrypsin deficiency. Genetics Home Reference: A Service of the National Library of Medicine. Available at http://ghr.nlm.nih.gov/condition=alpha1antitrypsindeficiency. (Accessed May 6, 2008.)
