Explore GLASSIA’s formulation, dosing, and administration settings.
Infusions take ~15 minutes.
With no reconstitution required, GLASSIA’s ready-to-administer formulation helps decrease administration steps—and the potential for preparation errors.1,2
†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.
Review GLASSIA’s demonstrated efficacy and safety profile.
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.
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.
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.
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:
||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.
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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.
GLASSIA is an Alpha1-Proteinase Inhibitor (Alpha1-PI) for chronic augmentation and maintenance therapy in adults with clinically evident emphysema due to severe hereditary deficiency of Alpha1‑PI. GLASSIA increases antigenic and functional serum levels ... and antigenic lung epithelial lining fluid levels of Alpha1‑PI. No randomized, controlled trials have demonstrated effects of Alpha1‑PI augmentation therapy on pulmonary exacerbations or emphysema progression. Clinical data on long-term effects of treatment with GLASSIA are not available.