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Alpha-1-Proteinase Inhibitor (Human) - Np (Aralast)

Trade Name : Aralast

Baxalta U.S. Inc.

KIT, PLASMA DERIVATIVE

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Alpha-1-Proteinase Inhibitor (Human) - Np (Aralast) which is also known as Aralast and Manufactured by Baxalta U.S. Inc.. It is available in strength of per ml. Read more

Alpha-1-Proteinase Inhibitor (Human) - Np (Aralast) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • ARALAST NP is an Alpha-Proteinase Inhibitor (Alpha-PI) indicated for chronic augmentation therapy in adults with clinically evident emphysema due to severe congenital deficiency of Alpha-PI (alpha-antitrypsin deficiency). ARALAST NP increases antigenic and functional (anti-neutrophil elastase capacity, ANEC) serum levels and antigenic lung epithelial lining fluid levels of Alpha-PI.
  • The effect of augmentation therapy with any Alpha-PI, including ARALAST NP, on pulmonary exacerbations and on the progression of emphysema in alpha-antitrypsin deficiency has not been conclusively demonstrated in randomized, controlled clinical trials.
  • Clinical data demonstrating the long-term effects of chronic augmentation and maintenance therapy with ARALAST NP or ARALAST are not available.
  • ARALAST NP is not indicated as therapy for lung disease in patients in whom severe congenital Alpha-PI deficiency has not been established.
  • ARALAST NP is an Alpha-Proteinase Inhibitor (Human) (Alpha-PI) indicated for chronic augmentation therapy in adults with clinically evident emphysema due to severe congenital deficiency of Alpha-PI (alpha-antitrypsin deficiency). ARALAST NP increases antigenic and functional (anti-neutrophil elastase capacity, ANEC) serum levels and antigenic lung epithelial lining fluid levels of Alpha-PI. ()
  • The effect of augmentation therapy with any Alpha-PI, including ARALASTu00a0NP, on pulmonary exacerbations and on the progression of emphysema in alpha-antitrypsin deficiency has not been conclusively 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 Alpha-PI deficiency has not been established. ()
  • For Intravenous Use Only
  • For Intravenous Use Only
  • ARALAST NP is available as a lyophilized powder in single dose vials containing 0.5 gram or 1 gram of functional Alpha-PI.
  • Available as a lyophilized powder in single dose vials containing 0.5u00a0gram or 1 gram of functional Alpha-PI. ()
  • ARALAST NP is contraindicated in immunoglobulin A (IgA) deficient patients with antibodies against IgA, due to the risk of severe hypersensitivity.
  • Immunoglobulin A (IgA) deficient patients with antibodies against IgA. ()
  • No data
  • Hypersensitivity reactions have been reported in patients following administration of ARALAST/ARALAST NP [see ].
  • No serious adverse reactions related to the use of ARALAST NP were reported in clinical trials. The most common adverse reactions occurring in u22655% of infusions in clinical trials were headache, musculoskeletal discomfort, vessel puncture site bruise, nausea, and rhinorrhea.
  • The most common adverse reactions occurring in u22655% of infusions in clinical studies were headache, musculoskeletal discomfort, vessel puncture site bruise, nausea, and rhinorrhea. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Baxalta US Inc. at 1-800-999-1785 or FDA at 1-800-FDA-1088 or .
  • No data
  • ARALAST NP contains approximately 2% Alpha-PI with truncated C-terminal lysine (removal of Lys394), whereas ARALAST contains approximately 67% Alpha-PI with the C-terminal lysine truncation. No known data suggest influence of these structural modifications on the functional activity and immunogenicity of Alpha-PI.n
  • ARALAST NP is a sterile, lyophilized preparation of purified human alpha-proteinase inhibitor (Alpha-PI), also known as alpha-antitrypsin (AAT). ARALAST NP is a similar product to ARALAST, containing the same active components of plasma Alpha-PI with identical formulations.
  • ARALAST NP 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.
  • To reduce the risk of viral transmission, the manufacturing process includes treatment with a solvent detergent (S/D) mixture [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). In addition, a nanofiltration step is incorporated into the manufacturing process to reduce the risk of transmission of enveloped and non-enveloped viral agents. Based on studies, the process used to produce ARALASTu00a0NP has been shown to inactivate and/or partition various viruses as shown in below.
  • The unreconstituted, lyophilized cake should be white or off-white to slightly yellow-green or yellow in color. When reconstituted as directed, the concentration of functionally active Alpha-PI is u226516 mg/mL and the specific activity is u22650.55 mg active Alpha-PI/mg total protein. The composition of the reconstituted product is as follows:
  • Each vial of ARALAST NP has the functional activity, as determined by inhibition of porcine pancreatic elastase, stated on the label. The formulation contains no preservative. The pH of the solution ranges from 7.2 to 7.8. Product must only be administered intravenously.
  • No data
  • Long-term studies in animals to evaluate the carcinogenic potential of ARALAST NP have not been conducted.u00a0 and testing of ARALAST NP for mutagenesis or impairment of fertility was not performed.
  • A clinical trial (ARALAST versus PROLASTIN trial) was conducted to compare the predecessor product ARALAST to a commercially available preparation of Alpha-PI (PROLASTIN) in 28 subjects with congenital Alpha-PI deficiency and emphysema, who had not received Alpha-PI augmentation therapy within the preceding six months.
  • Subjects were randomized to receive either ARALAST or PROLASTIN, 60 mg/kg intravenously per week for 10 consecutive weeks. Following their first 10 weekly infusions, the subjects who were receiving PROLASTIN were switched to ARALAST while those who already were receiving ARALAST continued to receive it. summarizes the mean serum antigenic and functional Alpha-PI trough levels measured prior to infusion at steady state (Weeks 8 through 11).
  • Following weekly augmentation therapy with ARALAST or PROLASTIN, a gradual increase in peak and trough serum Alpha-PI levels was noted, with stabilization after several weeks. The metabolic half-life of ARALAST was 5.9 days. Serum ANEC trough levels rose substantially in all subjects by Week 2, and by Week 3, serum ANEC trough levels exceeded 11 microM in the majority of subjects. With few exceptions, levels in both treatment groups remained above this level in individual subjects for the duration of the period Weeks 3 through 24. Although only five of fourteen subjects (35.7%) receiving ARALAST had BALs meeting acceptance criteria for analysis at both baseline and Week 7, a statistically significant increase in the antigenic level of Alpha-PI in epithelial lining fluid (ELF) was observed. No statistically significant increase in the ANEC in the ELF was detected.
  • It was concluded that at a dose of 60 mg/kg administered intravenously once weekly, ARALAST and PROLASTIN had similar effects in maintaining target serum Alpha-PI trough levels and increasing antigenic levels of Alpha-PI in the ELF with maintenance augmentation therapy.
  • The pharmacokinetic comparability of ARALAST NP and the predecessor product ARALAST was demonstrated in a randomized, double-blind, crossover trial in 25 subjects with severe Alpha-PI deficiency [see ].
  • Another clinical trial (BAL TRIAL) was conducted to determine the effects of open-label, weekly intravenous augmentation therapy with 60 mg/kg ARALAST NP on ELF levels of Alpha-PI, ANEC, and Alpha-PI: human neutrophil elastase (HNE) complexes in subjects with severe, congenital Alpha-PI deficiency. A total of 13 subjects completed 8 weekly infusions of ARALAST NP at a median dose of 63 (range: 58 to 67) mg/kg body weight at an infusion rate of 0.2 mL/kg/min. Of the 13 subjects, 12 had both baseline and post-treatment bronchoalveolar lavage samples. ARALAST NP augmentation therapy resulted in a significant increase (p<0.0001; n=12) in the mean plasma of antigenic Alpha-PI levels, from a median baseline level of 4.0 (range: 3.1 to 6.3) microM to a median post-treatment level of 14.6 (range: 11.1 to 18.1) microM. Post-treatment values of plasma Alpha-PI were above 11 microM in all 12 subjects. Median plasma functional Alpha-PI (ANEC) levels also increased significantly (p<0.0001; n=12) from a median baseline level of 2.5 (range: 1.6 to 3.0) microM to a median post-treatment level of 11.4 (range: 7.8 to 16.9) microM. While antigenic Alpha-PI levels in the ELF also increased significantly (p=0.0195; n=10) (Figure 2), only 4 out of 12 subjects were observed to have measurable ELF ANEC level in either or both lung lobes following 8 weekly infusions of ARALAST NP and the difference from baseline among these subjects did not reach statistical significance. Changes in the ELF analytes free and total human neutrophil elastase, Alpha-PI:HNE complexes, IL-8, and TNF alpha were either not statistically significant, or could not be analyzed due to limited data.
  • Figure 2 Changes in ELF Alpha-PI (AAT) Levels Following Intravenous Treatment with ARALAST NP (60 mg/kg/week) for 8 Weeks in Subjects with Severe Congenital Alpha-PI Deficiency
  • The clinical efficacy of ARALAST NP or any Alpha-PI product in influencing the clinical course of pulmonary emphysema in Alpha-PI deficiency has not been conclusively demonstrated in adequately powered, randomized, controlled clinical trials.
  • No data
  • How Supplied
  • ARALAST NP is available in the following kits:
  • Each kit contains a suitable volume of Sterile Water for Injection, USP diluent (25 mL for 0.5 gram vial; 50 mL for 1 gram vial), one sterile double-ended transfer needle, one sterile 20 micron filter and one package insert.
  • Storage and Handling
  • ARALAST NP is a trademark of Baxalta Incorporated, a wholly-owned, indirect subsidiary of Shire plc. SHIRE and the Shire Logo are trademarks or registered trademarks of Shire Pharmaceutical Holdings Ireland Limited or its affiliates.Prolastin is a trademark of Talecris Biotherapeutics, Inc.
  • Manufactured by:Baxalta US Inc.Lexington, MA 02421 USAU.S. License No. 2020
  • NDC 0944-2814-01 0.5 gram
  • Alpha-Proteinase Inhibitor (Human) Aralast NP
  • Solvent Detergent Treated Nanofiltered
  • Lyophilized powder for solution For intravenous use only
  • Shire
  • Shire NDC 0944-2803-03
  • 0.5 gram Alpha-Proteinase Inhibitor (Human) Aralast NP
  • Solvent Detergent Treated Nanofiltered Lyophilized powder for solution
  • ARALAST NP is a trademark of Baxalta Incorporated,a wholly-owned, indirect subsidiary of Shire plc.
  • Rx only
  • 25 mL NDC 52919-014-12 Shire
  • Sterile Water for Injection, USPfor reconstitution of accompanying product
  • See accompanying directions for use. Do not use unless clear. No antimicrobial agentor other substance has been added. Do not use for intravascular injection withoutmaking approximately isotonic by addition of suitable solute. Discard unused portion.Rx Only.
  • Single-Dose ContainerNonpyrogenic
  • 0742217
  • NDC 0944-2815-011 gram
  • Alpha-Proteinase Inhibitor (Human) Aralast NP
  • Solvent Detergent Treated Nanofiltered
  • Lyophilized powder for solution For intravenous use only
  • Shire
  • Shire NDC 0944-2804-04
  • 1 gram Alpha-Proteinase Inhibitor (Human) Aralast NP
  • Solvent Detergent TreatedNanofiltered Lyophilized powder for solution
  • ARALAST NP is a trademark of Baxalta Incorporated,a wholly-owned, indirect subsidiary of Shire plc.
  • Rx only
  • 50 mL NDC 52919-011-04 Shire
  • Sterile Water for Injection, USPfor reconstitution of accompanying product
  • Do not use unless clear. No antimicrobial agent or other substance has been added.Do not use for intravascular injection without making approximately isotonic byaddition of suitable solute. Discard unused portion.Rx Only
  • Single-Dose ContainerNonpyrogenic
  • 0742218

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