Get to know GLASSIA’s legacy of firsts.
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.
GLASSIA may be administered in the following settings—you and your patients decide what works best1
†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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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.
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.
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.
Help your patients enroll in OnePath after you and your patient choose a treatment path.
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.¶
¶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.
Call 1‑866‑888‑0660 Monday through Friday, 8:30 AM to 8:00 PM ET.Visit OnePath.com
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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.
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.
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.
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