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aralast np patient assistance

by Mara Schuppe IV Published 1 year ago Updated 1 year ago
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Patient Assistance & Copay Programs for Aralast NP Patient assistance programs (PAPs) are usually sponsored by pharmaceutical companies and provide free or discounted medicines and copay programs to low income or uninsured and under-insured people who meet specific guidelines. Eligibility requirements vary for each program.

Full Answer

What is Aralast NP used to treat?

It is used to treat adults with lung disease (emphysema) caused by severe Alpha 1 antitrypsin (AAT) deficiency. It is not known how increasing AAT levels with ARALAST NP or other Alpha 1 -PI products impacts worsening lung function or emphysema. The long-term effects of AAT with ARALAST NP have not been studied.

How is congenital alpha 1 deficiency treated with Aralast NP?

In a clinical trial, augmentation therapy with ARALAST NP was administered once weekly to patients with congenital Alpha 1 deficiency at a dose of 60 mg/kg. *†1 During weeks 8 through 11 of the clinical trial, steady-stage trough levels of serum antigenic and functional Alpha 1 -PI remained above the 11 µM theoretical protective level. 1

What is the typical dose of Aralast NP?

Following the first 10 weekly infusions, all patients received ARALAST NP at 60 mg/kg IV per week.

What is the efficacy of Aralast in the treatment of nephropathy?

Aralast NP augmentation therapy resulted in a significant increase (p<0.0001; n=12) in the mean plasma of antigenic Alpha 1 -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.

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What is Aralast NP?

Aralast NP offers may be in the form of a printable coupon, rebate, savings card, trial offer, or free samples. Some offers may be printed right from a website, others require registration, completing a questionnaire, or obtaining a sample from the doctor's office.

How much does Aralast cost?

The cost for Aralast NP intravenous powder for injection human is around $10 for a supply of 1 powder for injection, depending on the pharmacy you visit. Prices are for cash paying customers only and are not valid with insurance plans.

What is Aralast used for?

Aralast has been approved by the FDA for treatment in patients with emphysema. Aralast is administered as an injection.

How to enroll in Baxter Healthcare?

Fill out the program enrollment form located to your right. If you don't see an enrollment form available please call Baxter Healthcare Corporation program directly. After filling out the enrollment form please bring the form to your doctor for proper signatures and procedures. Do not forget a self stamped envelope for them to mail in your application to the program.

Does Baxter Healthcare offer Aralast?

Ara-Assist Program , a patient assistance program provided by Baxter Healthcare Corporation , offers Aralast at no cost to those who are eligible for the program. Eligibility is based off of the following requirements:

What is the purpose of Aralast NP?

Aralast NP administration is intended to inhibit serine proteases such as neutrophil elastase (NE), which is capable of degrading protein components of the alveolar walls and which is chronically present in the lung.

How many respiratory infections were reported in the ARALAST trial?

Twenty-six (26) of 27 (96.3%) subjects experienced a total of 94 upper and lower respiratory-tract infections during the 96-week trial (median: 3.0; range: 1 to 8; mean ± SD: 3.6 ± 2.3 infections). Twenty-eight (29.8%) of the respiratory infections occurred in 19 (70.4%) subjects during the first 24 weeks of the 96-week trial suggesting that the risk of infection did not change with time on ARALAST. In a post-hoc analysis, subjects experienced a range of 0 to 8 exacerbations of COPD over the 96-week trial with a median of less than one exacerbation per year (median: 0.61; mean ± SD: 0.83 ± 0.87 exacerbations per year).

What is the Alpha 1 versus Prolastin trial?

A clinical trial (ARALAST versus PROLASTIN trial) was conducted to compare the predecessor product ARALAST to a commercially available preparation of Alpha 1 -PI (PROLASTIN) in 28 subjects with congenital Alpha 1 - PI de ficiency and emphysema, who had not received Alpha 1 -PI augmentation therapy within the preceding six months.

How long is ARALAST trial?

ARALAST was evaluated for up to 96 weeks in 27 subjects with a congenital deficiency of Alpha 1 -PI and clinically evident emphysema. During the initial 10 weeks of the trial, subjects were randomized to receive either ARALAST or a commercially available preparation of Alpha 1 -PI (PROLASTIN).

How much lysine is in Aralast?

Aralast NP contains approximately 2% Alpha 1 -PI with truncated C-terminal lysine (removal of Lys394), whereas ARALAST contains approximately 67% Alpha 1 -PI with the C-terminal lysine truncation. 8 No known data suggest influence of these structural modifications on the functional activity and immunogenicity of Alpha 1 -PI. 9

How long does it take to reconstitute a 0.5 gram vial?

Reconstitution requires no more than five minutes for a 0.5 gram vial and no more than 10 minutes for a 1 gram vial. Note: Do not shake the content of the vial.

Is Aralast NP contraindicated?

Aralast NP is contraindicated in immunoglobulin A (IgA) deficient patients with antibodies against IgA, due to the risk of severe hypersensitivity.

What is Aralast NP?from drugs.com

Aralast NP is a protein (alpha 1-antitrypsin) that occurs naturally in the body and helps prevent breakdown of tissues in the lungs. People who lack this protein because of a genetic deficiency can develop damage to the air sacs in the lungs ( emphysema ).

What should I tell my doctor before using ARALAST NP?from aralastnp.com

Before starting ARALAST NP, tell your doctor if you have IgA deficiency with antibodies to IgA .

How much Aralast NP should I take?from drugs.com

Chronic augmentation therapy with a weekly dose of Aralast NP at 60 mg/kg body weight to patients with Alpha 1 -PI deficiency increases the level of the deficient protein in plasma and in the epithelial lining fluid (ELF) as determined by antigenic assay. Normal individuals have plasma levels of Alpha 1 -PI greater than 20 microM. The clinical benefit of increased blood and ELF levels of Alpha 1 -PI at the recommended dose has not been demonstrated in adequately powered, randomized, double-blind, placebo-controlled trials for any Alpha 1 -PI product.

What is the Alpha 1 versus Prolastin trial?from drugs.com

A clinical trial (ARALAST versus PROLASTIN trial) was conducted to compare the predecessor product ARALAST to a commercially available preparation of Alpha 1 -PI (PROLASTIN) in 28 subjects with congenital Alpha 1 - PI de ficiency and emphysema, who had not received Alpha 1 -PI augmentation therapy within the preceding six months.

How is Aralast NP prepared?from drugs.com

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.

What temperature should Aralast be stored at?from drugs.com

Store Aralast NP at temperatures not to exceed 25°C (77°F).

How long is ARALAST trial?from drugs.com

ARALAST was evaluated for up to 96 weeks in 27 subjects with a congenital deficiency of Alpha 1 -PI and clinically evident emphysema. During the initial 10 weeks of the trial, subjects were randomized to receive either ARALAST or a commercially available preparation of Alpha 1 -PI (PROLASTIN).

How much does Amitiza (lubiprostone) cost?from goodrx.com

Amitiza (lubiprostone) is available as a generic medication and may be significantly cheaper compared to the brand version. Unless there is a specific reason you need the brand, the generic medication will be a better value. For even more savings, use a GoodRx coupon and pay just a fraction of the retail price.

What are the risks and warnings for Amitiza (lubiprostone)?from goodrx.com

Amitiza (lubiprostone) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options

What is Amitiza (lubiprostone)?from goodrx.com

Amitiza (lubiprostone) is a chloride channel activator. It raises the amount of chloride and fluid in the intestines, so that stool can pass more loosely and easily.

How should I take Amitiza?from drugs.com

Amitiza is usually taken twice daily. Follow all directions on your prescription label and read all medication guides or instruction sheets.

What is lansoprazole used for?from takeda.com

Lansoprazole is a treatment for gastric acid-related disorders like gastroesophageal reflux disease (GERD).

Does Amitiza cause dyspnea?from drugs.com

There have been postmarketing reports of dyspnea when using Amitiza 24 mcg twice daily. Some patients have discontinued treatment because of dyspnea. These events have usually been described as a sensation of chest tightness and difficulty taking in a breath, and generally have an acute onset within 30 to 60 minutes after taking the first dose. They generally resolve within a few hours after taking the dose, but recurrence has been frequently reported with subsequent doses. Instruct patients to contact their healthcare provider if dyspnea occurs.

Is Amitiza contraindicated for mechanical gastrointestinal obstruction?from drugs.com

Amitiza is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction [see Warnings and Precautions (5.5)].

What is the phone number for OnePath?from glassialiquid.com

PATIENT SUPPORT MANAGERS ARE READY TO ASSIST YOU. Call OnePath at 1-866-888-0660. OnePath is available Monday through Friday, 8:30 AM to 8:00 PM ET. Keep the OnePath number (1-866-888-0660) in your phone so you don’t confuse us with spam calls.

How does Alpha 1 help the lungs?from glassialiquid.com

Alpha 1 circulates in your bloodstream and helps protect the elastic structures of your lungs from an enzyme that can attack normal body tissue. Without enough functional Alpha 1, lung damage can develop, usually in people between 20 and 50 years of age.

How many people have Alpha 1?from glassialiquid.com

Alpha 1 deficiency is caused by a genetic mutation that occurs in about 1 of every 3,000 to 5,000 people in the U.S. It’s also the most common genetic cause of emphysema.

Is Copayment Assistance transferable?from glassialiquid.com

Copayment assistance under the Program is not transferable. The Program only applies in the United States, including Puerto Rico and other U.S. territories, and does not apply where prohibited by law, taxed, or restricted. This does not constitute health insurance.

How much prolastin should I take?from rxlist.com

The recommended dosage of Prolastin (alpha) is 60 mg/kg body weight ad ministered once weekly. This dose is intended to increase and maintain a level of functional alpha 1 -PI in the epithelial lining of the lower respiratory tract, providing adequate anti-elastase activity in the lung of individuals with alpha 1 -antitrypsin deficiency.

What is the specific activity of prolastin?from rxlist.com

The specific activity of Prolastin is ≥ 0.35 mg functional alpha 1 -PI/mg protein and when reconstituted as directed, the concentration of alpha 1 -PI is ≥ 20 mg/mL. When reconstituted, Prolastin (alpha) has a pH of 6.6–7.4, a sodium content of 100–210 mEq/L, a chloride content of 60–180 mEq/L, a sodium phosphate content of 0.015–0.025 M, a polyethylene glycol content of not more than (NMT) 5 ppm, and NMT 0.1% sucrose. Prolastin (alpha) contains small amounts of other plasma proteins including alpha2-plasmin inhibitor, alpha 1 - antichymotrypsin, C 1 -esterase inhibitor, haptoglobin, antithrombinIII, alpha 1 -lipoprotein, albumin, and IgA. 1 Each vial of Prolastin (alpha) contains the labeled amount of functionally active alpha 1 -PI in milligrams per vial (mg/vial), as determined by capacity to neutralize porcine pancreatic elastase. 1 Prolastin (alpha) contains no preservative and must be administered by the intravenous route.

What is Alpha 1 PI?from rxlist.com

Alpha 1 -antitrypsin deficiency is a chronic, hereditary, usually fatal, autosomal recessive disorder in which a low concentration of alpha 1 -PI (alpha 1 -antitrypsin) is associated with slowly progressive, severe panacinar emphysema that most often manifests itself in the third to fourth decades of life. 2-9 [Although the terms “alpha 1 - Proteinase Inhibitor” and “alpha 1 -antitrypsin” are used interchangeably in the scientific literature, the hereditary disorder associated with a reduction in the serum level of alpha 1 -PI is conventionally referred to as “alpha 1 - antitrypsin deficiency” while the deficient protein is referred to as “Alpha1-Proteinase Inhibitor” 10 ]. The emphysema is typically worse in the lower lung zones. 4,8,9 The pathogenesis of development of emphysema in alpha 1 -antitrypsin deficiency is not well understood at this time. It is believed, however, to be due to a chronic biochemical imbalance between elastase (an enzyme capable of degrading elastin tissues, released by inflammatory cells, primarily neutrophils, in the lower respiratory tract) and alpha 1 -PI (the principal inhibitor of neutrophil elastase), which is deficient in alpha 1 -antitrypsin disease. 11-15 As a result, it is believed that alveolar structures are unprotected from chronic exposure to elastase released from a chronic, low-level burden of neutrophils in the lower respiratory tract, resulting in progressive degradation of elastin tissues. 11-15 The eventual outcome is the development of emphysema. Neonatal hepatitis with cholestatic jaundice appears in approximately 10% of newborns with alpha 1 -antitrypsin deficiency. 15 In some adults, alpha 1 - antitrypsin deficiency is complicated by cirrhosis. 15

What temperature should prolastin be stored at?from rxlist.com

Prolastin (alpha) should be stored at temperatures not to exceed 25°C (77°F). Freezing should be avoided as breakage of the diluent bottle might occur. REFERENCES. 1.Coan MH, Brockway WJ, Eguizabal H, et al: Preparation and properties of alpha 1 -proteinase inhibitor concentrate from human plasma.

How is prolastin prepared?from rxlist.com

Prolastin (alpha) is prepared from pooled human plasma of normal donors by modification and refinements of the cold ethanol method of Cohn. 1 Part of the fractionation may be performed by another licensed manufacturer. In order to reduce the potential risk of transmission of infectious agents, Prolastin (alpha) has been heat-treated in solution at 60±0.5°C for not less than 10 hours. However, no procedure has been found to be totally effective in removing viral infectivity from plasma fractionation products. In vitro studies designed to evaluate the capacity of the Prolastin (alpha) manufacturing process to remove/inactivate viruses have been conducted to provide additional assurance of the viral safety profile as shown in the table below.

How long does Alpha 1 PI last?from rxlist.com

18,19 The half-life of alpha 1 -PI in vivo was approximately 4.5 days. 18,19 Based on these observations, a program of chronic replacement therapy was developed. Nineteen of the subjects in these studies received Prolastin (alpha) replacement therapy, 60 mg/kg body weight, once weekly for up to 26 weeks (average 24 weeks of therapy). With this schedule of replacement therapy, blood levels of alpha 1 -PI were maintained above 80 mg/dL (based on the commercial standards for alpha 1 -PI immunologic assay). 18-20 Within a few weeks of commencing this program, bronchoalveolar lavage studies demonstrated significantly increased levels of alpha 1 -PI and functional antineutrophil elastase capacity in the epithelial lining fluid of the lower respiratory tract of the lung, as compared to levels prior to commencing the program of chronic replacement therapy with Alpha 1 -Proteinase Inhibitor (Human), Prolastin (alpha) . 18-20

How long does it take to infuse prolastin?from rxlist.com

The recommended dosage of 60 mg/kg takes approximately 30 minutes to infuse.

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