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For 10 years running, pulmonologists
have PRESCRIBED GLASSIA®

The first FDA‑approved liquid Alpha1 augmentation therapy

GLASSIA is for chronic augmentation and maintenance therapy in adults with clinically evident emphysema due to severe hereditary deficiency of Alpha1‑PI (alpha1‑antitrypsin deficiency).

The effect of augmentation therapy with GLASSIA or any Alpha1‑PI product on pulmonary exacerbations and on the progression of emphysema in Alpha1‑PI 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 GLASSIA are not available. GLASSIA is not indicated as therapy for lung disease in patients in whom severe Alpha1‑PI deficiency has not been established.

Ready to know more about GLASSIA?

Paving the way forward for liquid

innovation

Get to know GLASSIA’s legacy of firsts.

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The first FDA‑approved* liquid formulation

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 solution.1

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

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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.

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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/kg.1

WHEN YOU AND YOUR PATIENT HAVE CHOSEN A TREATMENT PATH

Initiate treatment and enroll your patient in product support.

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Clinical

clarity

for you and your patients

Get a clear understanding of our demonstrated efficacy and safety profile.

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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 50 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 with pulmonary exacerbations and on the progression of emphysema in Alpha1 deficiency has not been conclusively demonstrated in randomized, controlled trials.

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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.

INCREASED ALPHA1-PI IN THE BLOOD AND LUNGS1

Talk to your patients about the role Alpha1-PI plays in the blood and lungs, and if GLASSIA is the right treatment path for them.

Moving patients forward, with OnePath® personalized

product
support

Help your patients enroll in OnePath after you and your patient choose a treatment path.

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OnePath IS PERSONALIZED PRODUCT SUPPORT

After your patient enrolls in OnePath, he or she will receive a dedicated Patient Support Manager who will be his or her main point of contact throughout the treatment journey. The Patient Support Manager will work with your patient one-on-one to make sure he or she has access to the prescribed Takeda medication.

The Patient Support Manager will help your patient navigate many different aspects of therapy, from insurance and financial options to training and prescription fulfillment.

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OnePath helps your patients:

  • Navigate the health insurance process
  • Enroll in the OnePath Co-Pay Assistance Program or discuss financial assistance options
  • Coordinate medication delivery with the specialty pharmacy
  • Receive free self-administration training with a nurse (if appropriate)
  • Learn about additional support, education, and community resources
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ENROLLING YOUR PATIENTS IN ONEPATH

  • Ensure a OnePath start form is completed by the prescriber and is signed by both the prescriber and the patient
  • Fax the completed start form to OnePath at 1‑855‑ONEPATH (663‑7284)
  • Let the patient know to expect a call from the OnePath team and to add the OnePath phone number (1‑866‑888‑0660) to their phone so they don’t confuse the number for spam and miss the call
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The OnePath Co-Pay Assistance Program

OnePath offers eligible patients help covering the expense of their co-pays, including co-pay coverage for certain administration charges:

  • May provide 100% coverage, or coverage up to the program maximum#, for eligible commercially insured patients

OnePath is open to all patients taking GLASSIA for its indicated use and who complete the GLASSIA OnePath Start Form, which provides OnePath with consent to provide services.

#The OnePath CoPay Assistance Program (the Program) is not valid for prescriptions eligible to be reimbursed, in whole or 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 patient's insurance provider. If the patient's insurance situation changes the patient must notify the Program immediately at 1‑866‑888‑0660. Coverage of certain administration charges does not apply for patients residing in Massachusetts, Michigan, Minnesota, Rhode Island, and Vermont. Takeda reserves the right to rescind, revoke, or amend the Program at any time without notice.

Contacting OnePath is easy

Call 1‑866‑888‑0660 Monday through Friday, 8:30 AM to 8:00 PM ET.

Visit OnePath.com

Stay in the

KNOW

Sign up here to get the latest GLASSIA news and Alpha1 information. Want to learn about Takeda’s augmentation products and services, sites of care, and flexible network of specialty pharmacy providers? Request a call with a Takeda Sales Representative to connect with a resource focused on Alpha1 deficiency.


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Tools and
resources

for your practice

GLASSIA Dosage and Administration Guide

Dosing, ordering information, and step-by-step details on administration, for in-office or at-home infusion.

Download guide

Start your patient on GLASSIA

Initiate treatment and enroll your patient in OnePath.

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Indication and Limitations of Use:

GLASSIA is an Alpha1-Proteinase Inhibitor (Human) (Alpha1‑PI) indicated for chronic augmentation and maintenance therapy in adults with clinically evident emphysema due to severe hereditary deficiency of Alpha1‑PI (alpha1-antitrypsin deficiency). GLASSIA 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 GLASSIA or any Alpha1‑PI product on pulmonary exacerbations and on the progression of emphysema in Alpha1‑PI 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 GLASSIA are not available. GLASSIA is not indicated as therapy for lung disease in patients in whom severe Alpha1- PI deficiency has not been established.

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Important Safety Information

Contraindications

  • Immunoglobulin A (IgA) deficient patients with antibodies against IgA
  • History of anaphylaxis or other severe systemic reaction to Alpha1‑PI products.

Warnings and Precautions

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.

Transmissible Infectious Agents: Because GLASSIA is made from 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 and other pathogens. No seroconversions for hepatitis B or C or human immunodeficiency virus or any other known infectious agent were reported with the use of GLASSIA during the clinical trials.

Adverse Reactions

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

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

Please click for GLASSIA Full Prescribing Information.