Alpha1Health.com | Information about Managing your AAT Deficient Patient | ARALAST Tolerability

ARALAST Tolerability

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In a pivotal study1, there were:

  • No serious side effects and no antibody formation in patients receiving ARALAST.
  • No viral seroconversions observed during the pivotal study that were attributable to ARALAST.
  • The most common side effects in the study were headache (0.3%) and somnolence (0.3%).

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 review the ARALAST Full Prescribing Information

  1. Stoller JK, Rouhani F, Brantly M, et al. Biochemical efficacy and safety of a new pooled human plasma alpha1-antitrypsin, Respitin. Chest. 2002;122:66-74.
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