Prescribed since 20021

ARALAST® NP [Alpha1-Proteinase Inhibitor (Human)] is an Alpha1-Proteinase Inhibitor (Alpha1-PI) indicated for chronic augmentation therapy in adults with clinically evident emphysema due to severe congenital deficiency of Alpha1-PI (alpha1-antitrypsin deficiency).

ARALAST NP increases antigenic and functional (anti-neutrophil elastase capacity, ANEC) serum levels and antigenic lung epithelial lining fluid levels of Alpha1-PI. No randomized, controlled trials have demonstrated effects of augmentation therapy on pulmonary exacerbations or emphysema progression. Clinical data on long-term effects of ARALAST NP therapy are not available.

Please see full Indication and Limitations of Use below.

Aralast product

Know Alpha1-antitrypsin deficiency

Treating your patients with clinically evident emphysema due to severe congenital Alpha1-antitrypsin deficiency begins with understanding their condition.

Alpha1 deficiency is a hereditary disorder characterized by low serum and lung levels of Alpha1-PI.1

Severe variants are associated with slowly progressive emphysema, which manifests in the third to fourth decades of life.1

Augmentation therapy is indicated in patients with severe phenotypic variants who have clinically evident emphysema.1

Inheritance is in an autosomal codominant fashion.1

Learn about augmentation therapy

ARALAST NP is lyophilized for reconstitution and administered to patients as a once-weekly infusion.1

The recommended weekly dosage for ARALAST NP is 60 mg/kg.1

Administer ARALAST NP at a rate not to exceed 0.2 mL per kg body weight per minute, and as determined by the response and comfort of the patient.1

You and your patients can decide which setting is right for them.

Physician’s office

Infusion center

Home infusion via a home health agency

ARALAST NP was proven to increase Alpha1-PI levels in a clinical trial.1

In a clinical trial, augmentation therapy with ARALAST NP was administered once weekly to patients with congenital Alpha1 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 Alpha1-PI remained above the 11 µM theoretical protective level.1

There were no deaths and no serious adverse reactions associated with ARALAST NP or ARALAST administration in clinical trials. The most common adverse reactions (>0.5% of infusions) in clinical trials were headache and upper respiratory infection.1

*Study Design: ARALAST NP was evaluated in a randomized, double-blind trial with partial crossover involving 26 Alpha1-PI deficient patients receiving ARALAST NP (n=13) or the comparator (n=13) at a dose of 60 mg/kg IV per week for 10 consecutive weeks. Following the first 10 weekly infusions, all patients received ARALAST NP at 60 mg/kg IV per week. The objectives of the study were to: demonstrate the pharmacokinetics of antigenic and/or functional Alpha1-PI in ARALAST NP were not inferior to the control; and determine whether ARALAST NP maintained antigenic and/or functional Alpha1-PI of at least 11 µM (57 mg/dL). A second clinical trial in 13 patients with severe congenital Alpha1-PI deficiency evaluated safety and effects of weekly augmentation therapy on levels of Alpha1-PI in the epithelial lining fluid.1

†The effect of augmentation therapy on pulmonary exacerbations and on the progression of emphysema in Alpha1-antitrypsin deficiency has not been conclusively demonstrated in randomized, controlled clinical trials.1

Access resources for your practice

A variety of resources are available to help you get your patient started on treatment.

ARALAST NP Brochure
ARALAST NP Brochure
ARALAST NP Brochure

ARALAST NP Brochure

Use the brochure for additional information on ARALAST NP as well as product support for your patients.
Dosage and Administration Guide
Dosage and Administration Guide
Dosage and Administration Guide

Dosage and Administration Guide

Learn how ARALAST NP is lyophilized for reconstitution and administered as a once-weekly infusion.
Specialty Pharmacy Ordering Sheet
Specialty Pharmacy Ordering Sheet
Specialty Pharmacy Ordering Sheet

Specialty Pharmacy Ordering Sheet

Use the ordering sheet as you work with your patients to determine which specialty pharmacy is right for them.

OnePath is personalized product support after you and your patient choose a treatment plan.

OnePath provides a range of product support services throughout your patient’s ARALAST NP treatment journey.

From the moment your patients enroll in OnePath, a dedicated Patient Support Manager will work with them one-on-one to help them access their prescribed Takeda medication.

OnePath helps your patient:

Navigate the health insurance process

Enroll in the OnePath Co-Pay Assistance Program (if eligible) or discuss financial assistance options

Coordinate medication delivery with their specialty pharmacy (if applicable)

Learn about additional support, education, and community resources

The OnePath Co-Pay Assistance Program helps cover certain out-of-pocket treatment costs for eligible commercially insured patients prescribed ARALAST NP who are enrolled in OnePath.*

The following are covered up to the program maximum and may be paid directly to the provider:

  • 100% of eligible out-of-pocket costs, which may include deductibles, co-pays, and co-insurance
  • Out-of-pocket costs of eligible infusion charges, where applicable by law

At a minimum, to be eligible for the program, a patient must:

  • Be enrolled in OnePath
  • Have commercial insurance

For more information, please contact OnePath at 1-866-888-0660, Monday through Friday, 8:30 AM to 8:00 PM ET, or visit www.onepath.com.

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Other eligibility requirements apply.

*IMPORTANT NOTICE: The OnePath Copay Assistance Program (the Program) is not valid for prescriptions eligible to be reimbursed, in whole or in part, by Medicaid, Medicare (including Medicare Part D), Tricare, Medigap, VA, DoD, or other federal or state programs (including any medical or state prescription drug assistance programs). No claim for reimbursement of the out-of-pocket expense amount covered by the Program shall be submitted to any third party payer, whether public or private. The Program cannot be combined with any other rebate/coupon, free trial, or similar offer. 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. Void where use is prohibited by your insurance provider. If your insurance situation changes, you must notify the Program immediately at 1-866-888-0660. Coverage of certain administration charges will not apply for patients residing in states where it is prohibited by law. Takeda reserves the right to rescind, revoke, or amend the Program at any time without notice.

Indication

ARALAST NP is an Alpha1-Proteinase Inhibitor (Alpha1-PI) indicated for chronic augmentation therapy in adults with clinically evident emphysema due to severe congenital deficiency of Alpha1-PI (alpha1-antitrypsin deficiency). ARALAST NP increases antigenic and functional (anti-neutrophil elastase capacity, ANEC) serum levels and antigenic lung epithelial lining fluid levels of Alpha1-PI.

  • The effect of augmentation therapy with any Alpha1-PI, including ARALAST NP, on pulmonary exacerbations and on the progression of emphysema in alpha1-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 Alpha1 PI deficiency has not been established.

Important Safety Information

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

Warnings and Precautions

Hypersensitivity Reactions: ARALAST NP may contain trace amounts of IgA. Patients with known antibodies to IgA have a greater risk of developing severe hypersensitivity and anaphylactic reactions. Closely follow the recommended infusion rate, monitor vital signs continuously, and observe the patient carefully throughout the infusion. If hypersensitivity symptoms occur, discontinue the infusion and administer appropriate emergency treatment. Have appropriate supportive therapy available for any acute anaphylactic or anaphylactoid reaction.

Transmissible Infectious Agents: Because ARALAST NP is derived from pooled human plasma it may carry a risk of transmitting infectious agents such as viruses, the variant Creutzfeldt-Jakob disease (vCJD) and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. No seroconversions for hepatitis B or C or human immunodeficiency virus or any other known infectious agent were reported with the use of ARALAST NP during the clinical trials.

Adverse Reactions

Hypersensitivity reactions have been reported in patients following administration of ARALAST NP.

The most common adverse reactions (>0.5% of infusions) in clinical trials were headache, musculoskeletal discomfort, vessel puncture site bruise, nausea, and rhinorrhea.

Please click for ARALAST NP Full Prescribing Information.

Reference

  1. ARALAST NP [Alpha1-Proteinase Inhibitor (Human)] Injection Solution, prescribing information. Lexington, MA: Baxalta U.S. Inc. June 2017.