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How ARALAST NP Therapy Works
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ARALAST NP [Alpha1-Proteinase Inhibitor (Human)] is an augmentation therapy which works by increasing the levels of alpha-1 antitrypsin (AAT) in your blood and lungs.
Why AAT is Important
If you have AAT deficiency, your body does not produce enough A1-PI. Having the right amount of A1-PI, also called alpha-1 antitrypsin (AAT), is important to protect your lungs from damage caused by neutrophil elastase (NE), an enzyme released by white blood cells. To learn more about the important role AAT plays in protecting your lungs, read About Alpha-1.
How ARALAST NP Therapy Works
ARALAST NP therapy is administered by intravenous infusion once a week. With augmentation therapy, blood levels of A1-PI rise to levels exceeding the "protective threshold," as recommended by the American Thoracic Society and European Respiratory Society.1
It is important to understand that ARALAST NP augmentation therapy is not a cure for AAT deficiency. It cannot repair damage that has already occurred in your lungs. However, augmentation therapy with ARALAST NP therapy may slow further progression of lung disease.
About ARALAST NP Therapy
ARALAST NP therapy is a similar product to ARALAST therapy, containing the same active components of plasma α1-PI with identical formulations.2
ARALAST NP [Alpha1-Proteinase Inhibitor (Human)]
ARALAST NP is indicated for chronic augmentation therapy in patients having congenital deficiency of A1-PI with clinically evident emphysema. ARALAST NP is not indicated as therapy for lung disease patients in whom congenital A1-PI deficiency has not been established.
The effect of augmentation therapy with ARALAST NP on pulmonary exacerbations and on the progression of emphysema in alpha1-antitrypsin deficiency has not been demonstrated in randomized, controlled clinical trials.
Important Risk Information for ARALAST NP
ARALAST NP is contraindicated in IgA deficient patients with antibodies against IgA, due to the risk of severe hypersensitivity.
ARALAST NP is derived from pooled human plasma. It may carry a risk of transmitting infectious agents, e.g., viruses and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
The recommended rate of administration (≤ 0.08mL/kg/min) should be closely followed and vital signs monitored continuously. If anaphylactic or severe anaphylactic reactions occur, the infusion should be discontinued immediately.
Safety and effectiveness in patients over age 65 years of age have not been established.
ARALAST NP should be administered at room temperature within three (3) hours after reconstitution and should be administered alone, without mixing with other agents or diluting solutions.
The safety of ARALAST NP was evaluated with ARALAST in a crossover clinical PK comparability study. The most common adverse events deemed related to ARALAST NP included headache and musculoskeletal discomfort. No serious adverse reactions or deaths were reported in the study. In the ARALAST pivotal study, the most common adverse events were headache and somnolence.
Please see ARALAST NP Prescribing Information for full prescribing details.
References
- Stoller JK, Rouhani F, Brantly M, et al. Biochemical efficacy and safety of a new pooled human plasma alpha (1)-antitrypsin, Respitin. Chest. 2002; 122:66-74.
- ARALAST NP [Alpha1–Proteinase Inhibitor (Human)] Prescribing Information, Baxter International Inc., Westlake Village, CA; April 2010.
