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About ARALAST NP Therapy

ARALAST NP ARALAST NP

ARALAST NP Therapy Safety Profile

The processing of ARALAST NP therapy is designed to help reduce the risk of viral transmission with two key steps.

  • Solvent Detergent (S/D) treatment using tri-n-butyl phosphate and polysorbate 80 to inactivate enveloped viral agents such as human immunodeficiency virus (HIV), hepatitis B (HBV), and hepatitis C (HCV)
  • Nanofiltration to reduce the risk of transmission of enveloped and non-enveloped viral agents
  • As with all plasma-derived therapeutics, the potential to transmit infectious agents, e.g. viruses, and theoretically, the Creutzfeld-Jakob disease (CJD) agent can not be totally eliminated. Please refer to the ARALAST NP Important Risk Information on this page for more detailed information.

ARALAST NP therapy is prepared from large pools of human plasma by using the cold ethanol fractionation process, followed by purification steps including polyethylene glycol and zinc chloride precipitations and ion exchange chromatography.

Based on in vitro studies, the process used to produce ARALAST NP therapy has been shown to inactivate and/or partition various viruses as shown in Table 1 below.

Table 1: Virus Log Reduction in ARALAST NP Manufacturing Process1

Processing Step Virus Log Reduction Factors
HIV-1 BVDV PRV HAV MMV
Cold ethanol fractionation 4.6 1.4 2.1 1.4 ≤1.0*
Solvent Detergent-treatment >5.8 >6.0 >5.5 N/A N/A
15 N nanofiltration >5.3 >6.0 >5.6 >5.1 4.9
Overall reduction factor >15.7 >13.4 >13.2 >6.5 4.9
*
Reduction factors ≤ 1.0 are not used for calculation of the overall reduction factor
N/A
Not applicable; study did not test for virus indicated
HIV-1
Human immunodeficiency virus-1
BVDV
Bovine Viral Diarrhea Virus, model for Hepatitis C Virus and other lipid enveloped RNA viruses
PRV
Pseudorabies Virus, model for lipid enveloped DNA viruses, to which also hepatitis B belongs
HAV
Hepatitis A Virus
MMV
Mice Minute Virus, model for small non-lipid enveloped DNA viruses

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.

Important Risk Information for ARALAST NP

ARALAST NP is contraindicated in individuals with selective IgA deficiencies (IgA level less than 15 mg/dL) who have known antibody against IgA, since they may experience severe reactions, including anaphylaxis.

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.

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

  1. ARALAST NP [Alpha1–Proteinase Inhibitor (Human)] Prescribing Information, Baxter Healthcare Corporation; May 2007.