ARALAST NP [Alpha1-Proteinase Inhibitor (Human)]

The information contained in this page is intended for U.S. healthcare professionals only.

Indications & Usage

ARALAST NP is an Alpha1-Proteinase Inhibitor (Alpha1-PI) indicated for chronic augmentation therapy in adults with clinically evident emphysema due to severe congenital deficiency of Alpha1-PI (alpha1-antitrypsin deficiency). ARALAST NP increases antigenic and functional (anti-neutrophil elastase capacity, ANEC) serum levels and antigenic lung epithelial lining fluid levels of Alpha1-PI.

The effect of augmentation therapy with any Alpha1-PI, including ARALAST NP, on pulmonary exacerbations and on the progression of emphysema in alpha1-antitrypsin deficiency has not been demonstrated in randomized, controlled clinical trials.

Clinical data demonstrating the long term effects of chronic augmentation and maintenance therapy of individuals with ARALAST NP or ARALAST are not available.

ARALAST NP is not indicated as therapy for lung disease in patients in whom severe congenital Alpha1-PI deficiency has not been established.

Important Risk Information

HYPERSENSITIVITY

  • ARALAST NP is contraindicated in immunoglobulin A (IgA) deficient patients with antibodies against IgA, or individuals with a history of severe immediate hypersensitivity reactions, including anaphylaxis to Alpha1-PI products.
  • Hypersensitivity reactions have been reported in patients following administration. Patients should be closely followed and vital signs monitored continuously. Discontinue the infusion if hypersensitivity symptoms occur and administer appropriate emergency treatment.

TRANSMISSION OF INFECTIOUS AGENTS

  • ARALAST NP is derived from pooled human plasma and may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. Despite manufacturing steps designed to minimize the risk of viral transmission, such products may still potentially transmit human pathogenic agents.

USE DURING PREGNANCY

  • ARALAST NP should not be given to pregnant women unless clearly needed, as reproduction studies have not been done in animals or humans.

ADVERSE REACTIONS

  • In clinical trials there were no deaths and no serious adverse reactions associated with ARALAST NP. The most common adverse reactions occurring in ≥5% of infusions in clinical trials were headache, musculoskeletal discomfort, vessel puncture site bruise, nausea, and rhinorrhea.

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Material Safety Data Sheet

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