Know Alpha₁-antitrypsin deficiency

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

Double helix DNA indicating Alpha1 deficiency is a hereditary disorder.

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

Family tree depicting inheritance of normal Alpha1 gene vs deficient Alpha1 gene.

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 occurring in ≥5% of infusions in clinical studies were headache, musculoskeletal discomfort, vessel puncture site bruise, nausea, and rhinorrhea.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.

Tailored support for your patient’s prescribed Alpha₁ augmentation therapy

Because AATD looks different for everyone

After you and your patient choose a treatment path, Takeda Patient Support is here with a range of personalized services for them.

We know living with Alpha₁-antitrypsin deficiency looks different for everyone. Whether they’ve just been diagnosed or have been on treatment for a long time, we get to know your patient. We work to understand who they are, and we learn what’s most important to them—so we can help provide the support they need when it comes to their treatment.

From the moment they enroll, dedicated support specialists will work with them.

Need to enroll your patient? Download and fax a printed start form to 1-844-755-5751. To learn more about Takeda Patient Support, visit www.takedapatientsupport.com/hcp/aralastnp.

Benefits investigation to help determine your patient’s insurance benefits and eligibility for certain services

Prior authorization (PA), reauthorization, and appeals information

Enrollment into the Takeda Patient Support Co-Pay Assistance Program, if they qualify*

Information about financial assistance options, if they’re eligible

Specialty pharmacy (or site of care) triage and coordination

Takeda product infusion training for healthcare providers, as well as home treatment support and education for your patient

Directing your patient to community support resources

*To be eligible, your patient must be enrolled in Takeda Patient Support and have commercial insurance. Other terms and conditions apply.
Call us for more details.

How to get your patients started on ARALAST NP:

Complete and sign the Start Form
Have your patient sign the Patient Authorization section
Takeda Patient Support will review the Start Form and confirm patient eligibility
Your patient will then receive a welcome call from their dedicated support specialist
The support specialist will get them started with Takeda Patient Support

DOWNLOAD AND FAX

Explore patient assistance programs.

Financial assistance options
At Takeda Patient Support, our support specialists will review your patient’s coverage and help them understand what financial options may be available.

For commercially insured patients
The Takeda Patient Support Co-Pay Assistance Program helps eligible, commercially insured patients pay as little as $0 per prescription.^†

See below for terms and conditions.

Need assistance?

Our support specialists are never more than a tap or a call away–1-866-888-0660, Monday through Friday, 8:30 AM to 8 PM ET. If English is not your patient’s preferred language, Takeda Patient Support can communicate with them over the phone using a translation service.

^†IMPORTANT NOTICE: Takeda's Co-pay Assistance Program ("the Program") provides financial support for commercially insured patients who qualify for the Program. Participation in the Program and provision of financial support is subject to all Program terms and conditions, including but not limited to eligibility requirements, the Program maximum benefit per claim and the annual calendar year Program maximum ("Annual Program Maximum"). The Annual Program Maximum for your prescribed Takeda product can be found by visiting: www.takedapatientsupport.com/copay.

By enrolling in the Program, you agree that the Program is intended solely for the benefit of you—not health plans and/or their partners. Further, you agree to comply with all applicable requirements of your health plan. The Program cannot be used if the patient is a beneficiary of, or any part of the prescription is covered by: 1) any federal, state, or government-funded healthcare program (Medicare, Medicare Advantage, Medicaid, TRICARE, etc.), including a state pharmaceutical assistance program (the Federal Employees Health Benefit (FEHB) Program is not a government-funded healthcare program for the purpose of this offer), 2) the Medicare Prescription Drug Program (Part D), or if the patient is currently in the coverage gap, or 3) insurance that is paying the entire cost of the prescription. 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.

Some health plans have established programs referred to as ‘co-pay maximizer' programs. A co-pay maximizer program is one in which the amount of a patient's out-of-pocket costs is adjusted to reflect the availability of support offered by a manufacturer's co-pay assistance program. If you are enrolled in a co-pay maximizer program, your Annual Program Maximum may vary over time to ensure the program funds are used for your benefit (for the benefit of the patient). Takeda also reserves the right to reduce or eliminate the co-pay assistance available to patients enrolled in an insurance plan that utilizes a co-pay maximizer program.

If you learn your health plan has implemented a co-pay maximizer program, you agree to notify the Program immediately by calling 1-866-888-0660. It may be possible that you are unaware whether you are subject to a co-pay maximizer program when you enroll or re-enroll in the Program. Takeda will monitor program utilization data and reserves the right to discontinue assistance under the Program at any time if Takeda determines that you are subject to a co-pay maximizer, or similar program.

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.

This Program offer is not transferable and is limited to one offer per person and may not be combined with any other coupon, discount, prescription savings card, rebate, free trial, patient assistance, co-pay maximizer, alternative funding program, co-pay accumulator, or other offer, including those from third parties and companies that help insurers or health plan manage costs. Not valid if reproduced.

By utilizing the Program, you hereby accept and agree to abide by these terms and conditions. Any individual or entity who enrolls or assists in the enrollment of a patient in the Program represents that the patient meets the eligibility criteria and other requirements described herein. You must meet the Program eligibility requirements every time you use the Program. Takeda reserves the right to rescind, revoke, or amend the Program at any time without notice, and other terms and conditions may apply.

Prescribed since 2002¹