ARALAST NP
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 alpha-1 antitrypsin deficiency has not been demonstrated in randomized, controlled clinical trials.1 Clinical data demonstrating the long term effects of chronic augmentation or replacement therapy of individuals with ARALAST NP or ARALAST are not available.
ARALAST NP is made with a two-step viral treatment process, solvent detergent and nanofiltration, to reduce the risk of viral transmission.1 The solvent detergent method destroys lipid membranes, thereby inactivating lipid-enveloped viruses. The nanofiltration process removes pathogens by size exclusion.2
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.1
What does ARALAST NP do?
Studies show that ARALAST NP augments the concentration of A1-PI in the blood and lungs.1
The most common adverse events deemed related to ARALAST NP included headache and musculoskeletal discomfort.1
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.
- 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.
- Clinical data demonstrating the long-term effects of chronic augmentation or replacement therapy of individuals with ARALAST NP or ARALAST are not available.
- ARALAST NP is not indicated as therapy for lung disease patients in whom congenital A1-PI deficiency has not been established.
Detailed 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 (≤0.08 mL/kg/min) should be closely followed and vital signs monitored continuously. If anaphylactic or severe anaphylactoid 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 Full Prescribing Information for full prescribing details.
References
- ARALAST NP [Alpha1–Proteinase Inhibitor (Human)] Prescribing Information. Baxter Healthcare Corporation, April 2010.
- Pathogen Safety Monograph. Baxter Healthcare Corporation, 2010.
