Glassia | The First FDA-Approved Liquid Augmentation Therapy for Severe Alpha1-Antitrypsin Deficiency with Emphysema

A LEGACY OF FIRSTS

Explore GLASSIA’s formulation, dosing, and administration settings.

The first FDA-approved^† liquid Alpha₁ augmentation therapy

Infusions take ~15 minutes.

Infusion time is based on a maximum rate of 0.2 mL/kg/min and a recommended dosage of 60 mg/kg¹

With no reconstitution required, GLASSIA’s ready-to-administer formulation helps decrease administration steps—and the potential for preparation errors.^1,2

Each single-use vial of GLASSIA contains approximately 1 gram (1000 mg) of functional Alpha₁‑PI in 50 mL of solution¹

^†GLASSIA was approved by the FDA on July 1, 2010.

The first and only Alpha₁ augmentation therapy approved for self-administration^‡

GLASSIA may be administered in the following settings—you and your patients decide what works best¹:

Physician’s office
Infusion center
Home infusion via a home health agency
Self-administration by a patient or caregiver, after appropriate training^‡

^‡If self-administration is deemed appropriate, ensure that the patient/caregiver receives detailed instructions and adequate training on how to administer in the home or other appropriate setting and has demonstrated the ability to independently administer GLASSIA.

CLINICALLY PROVEN TO INCREASE ALPHA₁ LEVELS

Review GLASSIA’s demonstrated efficacy and safety profile.

Proven to increase Alpha₁ levels

In a clinical trial,^§¶ patients taking GLASSIA were found to have increased levels of Alpha₁‑PI in their blood and lungs.¹

100% of the 33 GLASSIA-treated subjects had mean trough antigenic Alpha₁‑PI levels greater than 11 µM during Weeks 7–12 of the study.¹

66.7% of GLASSIA-treated subjects (22/33) had mean steady-state functional PI levels above the 11 µM threshold, while 33.3% of subjects (11/33) did not.¹

^§Study Design: The study was a randomized, double-blind trial with partial crossover involving 50 Alpha₁‑PI deficient patients receiving GLASSIA (n=33) or the comparator (n=17) at a dose of 60 mg/kg IV per week for 12 weeks. From Weeks 13 to 24, all patients received open-label GLASSIA 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 GLASSIA were not inferior to the control; and determine whether GLASSIA maintained antigenic and/or functional Alpha₁‑PI of at least 11 µM (57 mg/dL).¹

^¶The effect of augmentation therapy on pulmonary exacerbations and on the progression of emphysema in Alpha₁ deficiency has not been conclusively demonstrated in randomized, controlled trials.

Demonstrated safety profile

The serious adverse reaction observed during clinical trials^# with GLASSIA was exacerbation of chronic obstructive pulmonary disease (COPD).¹

The most common adverse reactions (>0.5% of infusions) in clinical trials were headache and upper respiratory infection.¹

^#Safety of GLASSIA was evaluated in the clinical study and an open-label, non-parallel, dose-escalation trial involving 65 subjects with pre-augmentation therapy serum Alpha₁‑PI levels less than 11 μM.

Hypersensitivity: GLASSIA may contain trace amounts of IgA. Monitor vital signs continuously and observe the patient throughout the infusion. If hypersensitivity symptoms occur, discontinue the infusion and administer appropriate emergency treatment. Have epinephrine and/or other appropriate supportive therapy available for any acute anaphylactic or anaphylactoid reaction.

TAILORED SUPPORT FOR YOUR PATIENTS

When you prescribe GLASSIA for your patients, OnePath is here to provide them dedicated product support.

At OnePath, 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 understand who they are, and we learn what’s most important to them—so we can focus on what they specifically need when it comes to their prescribed Takeda therapy.

We’ll connect your patient with a Patient Support Manager (PSM) who acts as their go-to person. They will:

Work with your patient’s insurance provider to help them receive their prescribed Takeda treatment

Enroll your patient in the OnePath Co-Pay Assistance Program, if they qualify^||

Coordinate the shipment and delivery of your patient’s medication by working with a specialty pharmacy

Address your patient’s questions and concerns

Get your patient the information they need or find the right person who can

Arrange for a trained nursing professional to teach your patient or their caregiver how to infuse GLASSIA at home, once requested by your office

Provide ongoing support to your patient throughout their GLASSIA treatment, which includes directing them to educational resources and much more

The OnePath Co-Pay Assistance Program can help your patients save on their prescribed Takeda treatment.^**

The program can cover up to 100% of your patient’s out-of-pocket co-pay costs, if they’re eligible. To be eligible for this program, your patients must:

Be prescribed a Takeda treatment for an FDA-approved indication.
Have commercial insurance. This includes Health Insurance Marketplace plans.
- Commercial insurance does not include Medicare, Medicaid, Veterans Affairs (VA), or other federal or state health plans
Be enrolled in OnePath.

SEE BELOW FOR TERMS AND CONDITIONS.

If you have questions, call OnePath at 1‑866‑888‑0660, Monday through Friday, 8:30 AM to 8:00 PM ET, or visit www.onepath.com.

If English is not your patient’s preferred language, we can communicate with them over the phone using a translation service.

^||To be eligible, patients must be enrolled in OnePath and have commercial insurance. Other terms and conditions apply. Call OnePath for more details.

^**IMPORTANT NOTICE: The OnePath Co-Pay 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.

How to get your patients started

Complete and sign the Start Form
Have your patients sign the Patient Authorization section

Access OnePath Start Form

What your patients can expect next

OnePath will review the Start Form and confirm patient eligibility
Your patients will then receive a welcome call from their dedicated PSM
The PSM will get them started on OnePath

THE MOST ADMINISTRATION OPTIONS

A LEGACY OF FIRSTS

The first FDA-approved^† liquid Alpha₁ augmentation therapy

The first and only Alpha₁ augmentation therapy approved for self-administration^‡

When you and your patient have chosen a treatment path