Alpha1Health.com | Options for your New AAT Deficient Patient | ARALAST and Viral Safety

ARALAST & Viral Safety

Alpha1Health.com Survey

Take the Alpha1Health.com Survey

Take our survey to help us best meet the needs of the Alpha-1 community.

 

eLearning Program

AlphaTest® Kit

View our eLearning Program to learn more about Alpha-1

 

ARALAST is manufactured for Baxter, a leader in the field of plasma processing. The processing of ARALAST is designed to help reduce the risk of viral transmission with two key steps. ARALAST is the only A1-PI therapy that utilizes both:

  • Solvent/detergent – inactivates lipid-enveloped viruses (eg, HIV, HBV, HCV)
  • Nanofiltration – reduces the risk of transmission of nonlipid-enveloped viruses (eg, HAV, parvovirus B19)

*Viruses (numbers shown in table) were deliberately added and eliminated.
†HIV-1: Fractionation units log10, SFU SD treatment units log10, TCID50/mL
‡BVD (bovine viral diarrhea), PRV (Pseudorabies virus): SD treatment unit log10, PFU/mL, nanofiltration units log10, PFU
§HAV (hepatitis A), PPV (porcine parvovirus), nanofiltration units log10, PFU
•Not applicable

As with all plasma-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.

Please review the ARALAST Full Prescribing Information

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