Alpha1Health.com | Information about Alpha-1 Antitrypsin Deficiency and Therapies | About ARALAST

About ARALAST

ARALAST [Alpha1-Proteinase Inhibitor (Human)] is a sterile, stable, lyophilized preparation of purified human alpha1-proteinase inhibitor (A1-PI) also known as alpha1-antitrypsin (AAT).

ARALAST is prepared from large pools of human plasma by using the Cohn-Oncley cold alcohol fractionation process, followed by purification steps including polyethylene glycol and zinc chloride precipitations and ion exchange chromatography. To reduce the risk of viral transmission, the manufacturing process includes treatment with a solvent detergent (SD) mixture [tri-n-butyl phosphate and polysorbate 80] to inactivate enveloped viral agents such as HIV and Hepatitis B and C. In addition, a nanofiltration step is incorporated prior to final sterile filtration to reduce the risk of transmission of non-enveloped viral agents.

As with all derived therapeutics, the potential to transmit infectious agents cannot be totally eliminated.

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.
adobe reader To view PDF, you will need Adobe® Acrobat® Reader® software.