ARALAST Tolerability
ARALAST has an acceptable tolerability profile. 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)] 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 Important Safety Information and the Full Prescribing Information
- 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.
 |
To view PDF, you will need Adobe® Acrobat® Reader® software. |
