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ARALAST Efficacy

ARALAST replaces or augments the concentration of alpha1-proteinase inhibitor (A1-PI) in the blood of AAT-deficient patients. Ultimately, this leads to elevated concentrations of A1-PI in the epithelial lining fluid (ELF) of the lower respiratory tract.

In the ELF:

  • ARALAST increases A1-PI activity in the ELF ≈ 6- fold (mean rise: 1, 103 µM) at 7 weeks.1

In serum:

  • ARALAST exceeds ATS/ERS standards for A1-PI serum concentrations by 31%.1 (The ATS/ERS considers 11 µM to be the "protective threshold," above which the lung appears to be able to protect itself adequately.2,3)

ARALAST [Alpha1-Proteinase Inhibitor (Human)] 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.
  1. 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.
  2. American Thoracic Society/European Respiratory Society Statement. Standards for the diagnosis and management of individuals with alpha-1 antitrypsin deficiency. Am J Respir Crit Care Med. 2003; 168:818-900.
  3. American Thoracic Society. Guidelines for the approach to the patient with severe hereditary alpha-1- antitrypsin deficiency. Am Rev Respir Dis. 1989; 140:1494-1497.
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