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About ARALAST NP Therapy

ARALAST NP ARALAST NP

ARALAST NP Efficacy

ARALAST NP therapy replaces or augments the concentration of alpha1-proteinase inhibitor (A1-PI) in the blood of AAT-deficient patients. Ultimately, this leads to elevated concentrations of A1-PI in the epithelial lining fluid (ELF) of the lower respiratory tract.

Important Risk Information for
ARALAST NP

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.

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 rate of administration 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.

Please refer to the ARALAST NP Important Risk Information at the bottom of the page for detailed risk information and the ARALAST NP Prescribing Information link for full prescribing details.

In the ELF:

  • Data from a randomized, double blind study demonstrate ARALAST therapy* increases A1-PI activity in the ELF ≈ 6- fold (mean rise: 1, 103 µM) at 7 weeks.1

In serum:

  • The ATS/ERS considers 11 µM to be the "protective threshold," above which the lung appears to be able to protect itself adequately.2 Study data demonstrates that ARALAST therapy* exceeds ATS/ERS standards for A1-PI serum concentrations by 31%.

*ARALAST NP therapy is a similar product to ARALAST therapy, containing the same active components of plasma α1-PI with identical formulations. The pharmacokinetics profile of ARALAST NP therapy was compared with ARALAST therapy in a multicenter, single-dose, randomize, double-blind, crossover clinical study.3 Results showed that plasma A1-PI concentration levels were statistically similar for both therapies.

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

  1. 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.
  2. American Thoracic Society/European Respiratory Society Statement. Standards for the diagnosis and management of individuals with alpha-1 antitrypsin deficiency. Am J Respir Crit Care Med. 2003; 168:818-900.
  3. ARALAST NP [Alpha1–Proteinase Inhibitor (Human)] Prescribing Information, Baxter International Inc., Westlake Village, CA; April 2010.