Glassia is an alpha-1 proteinase inhibitor (also known as alpha-1 PI). It's an enzyme replacement that's used as augmentation therapy to manage lung problems (emphysema) in adults with a genetic condition called alpha-1 antitrypsin (AAT) deficiency. Glassia is given as an infusion into the veins (IV) once a week. Side effects aren't common, but can include headache and common cold symptoms.
Augmentation therapy for lung damage (emphysema) due to severe alpha-1 antitrypsin (AAT) deficiency
People with alpha-1 antitrypsin (AAT) deficiency have little to no AAT in their body. AAT, also known as alpha-1 proteinase inhibitor, is an enzyme that your body normally makes to help protect the lungs from damage. Without enough AAT, there's a higher risk for lung problems, like emphysema.
Glassia is an enzyme replacement therapy. It helps restore the levels of AAT in the body to help protect the lungs.
Source: DailyMed
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
More common
Bladder pain
bloody or cloudy urine
body aches or pain
chills
difficult, burning, or painful urination
difficulty with breathing
ear congestion
frequent urge to urinate
headache
loss of voice
lower back or side pain
runny or stuffy nose
unusual tiredness or weakness
Rare
Bloating or swelling of the face, arms, hands, lower legs, or feet
blurred vision
cough producing mucus
difficult or labored breathing
dizziness
feeling faint, dizzy, or lightheadedness
flushing or redness of the skin, especially on the face and neck
general feeling of discomfort or illness
joint pain
loss of appetite
muscle aches and pains
nervousness
noisy breathing
pounding in the ears
rapid weight gain
shivering
slow or fast heartbeat
sweating
tightness in the chest
tingling of the hands or feet
trouble sleeping
unusual weight gain or loss
vomiting
Incidence not known
Confusion
difficulty with swallowing
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
fast, pounding, or irregular heartbeat or pulse
hives or skin rash
itching, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Helps replace missing AAT in your body
Can be given by a provider, caregiver, or yourself
Only need to take once a week
Available as a liquid that's already mixed and ready to inject
Not clear if it can slow the worsening of emphysema due to AAT deficiency
Needs to be given as an infusion into the vein
Might be difficult for some people to prepare and administer properly
Mark your once-weekly Glassia infusions, any blood work appointments, and visits to your provider in your calendar. This will help you and your provider keep track of your treatment.
You might experience an allergic reaction or infusion-related reaction during or after your Glassia infusion. Get medical help right away if you have any signs or symptoms of an allergic reaction, including trouble breathing or rash, so you can get treated as soon as possible.
How to infuse Glassia by yourself at home (if instructed by your provider):
Make sure you or your caregiver gets trained on how to prepare your dose and infuse Glassia into your vein properly and safely. Carefully read the instructions for use, and contact your provider or pharmacist if you have any questions on how to use this medication.
Keep a treatment infusion log to help you and your provider keep track of your infusions. Write down the lot number of the vial you use, the time and date of your infusion, and any reactions that you have.
Store Glassia vials in the refrigerator and in the original container to protect them from light. The medication can also be stored at room temperature for up to 1 month, which might be helpful if you're traveling or if you don't have access to a refrigerator. Once the medication is at room temperature, don't put it back in the refrigerator.
When it's time for your Glassia infusion, take the medication out of the refrigerator and let it reach room temperature. Don't shake it or try to warm it up any other way because this can damage the medication.
Always check that the liquid inside the vial is clear and colorless to yellow-green before using it. It also might contain a few protein particles, which is normal. Don't use the vial if it's cloudy or if it has particles. Use a different vial if this happens.
After washing your hands and putting on gloves, follow your provider's instructions to prepare the Glassia vial(s). Your provider will also tell you whether you should infuse the medication directly from the vial(s) or put the medication into an empty sterile bag that's then infused.
Use Glassia within 3 hours of preparing your dose. Don't use the medication if it's been more than 3 hours since you've prepared it. The medication doesn't contain any preservatives, so bacteria might start to grow in the solution if it hasn't been used for some time.
For each Glassia infusion, use an infusion site that's different from the last time. This will help prevent bruising or irritation to your skin.
Each Glassia vial is for a one-time use only. Throw away any unused solution, used syringes, and used needles by placing them in a sharps container or something made of heavy-duty plastic (e.g., laundry detergent bottle). This lowers the risk of needle-stick injuries. Don't throw them away in the trash. Visit the FDA's website to learn more about following your state regulations to dispose your sharps safely.
Glassia can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Risk factors: Immunoglobulin A (IgA) deficiency
Glassia might contain a tiny amount of immunoglobulin A (IgA), which is a type of protein that's naturally found in the body. People who have IgA deficiency can have antibodies against IgA. Having antibodies against IgA raises the risk of having an allergic reaction, including anaphylaxis, to Glassia.
Let your provider know right away or contact emergency medical help if you have any signs or symptoms of a severe allergic reaction, such as hives, itching, swelling in the mouth or throat, chest tightness, trouble breathing, wheezing, or feeling faint or lightheaded. Your provider might prescribe an epinephrine pen (EpiPen) for you to use in case of a severe allergic reaction.
Because Glassia is made from human blood products, there's a risk that it might contain viruses and other germs that can make you sick. But your risk of infection is low since the donors of these blood products are carefully screened. Also, there are high manufacturing standards put into place to make sure the germs are killed or removed.
To prevent serious infections in the rare case that your doses of Glassia are affected, let your provider know right away if you start to feel sick or have symptoms, such as feeling confused and anxious or having trouble maintaining your balance.
The typical dose is 60 mg/kg of body weight, given as an infusion into the vein (intravenous or IV) once a week.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
People who are immunoglobulin A (IgA) deficient with antibodies against IgA
Severe allergy to other alpha 1-proteinase inhibitors
Augmentation therapy for lung damage (emphysema) due to severe alpha-1 antitrypsin (AAT) deficiency
Augmentation therapy for lung damage (emphysema) due to severe alpha-1 antitrypsin (AAT) deficiency
Augmentation therapy for lung damage (emphysema) due to severe alpha-1 antitrypsin (AAT) deficiency
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American Lung Association. (2023). Treating and managing alpha-1 antitrypsin deficiency.
Li, Z., et al. (2022). Comparative biochemical efficacy analysis of an alpha1-proteinase inhibitor (Glassia®) in patients with alpha-1 antitrypsin deficiency. Pulmonary Pharmacology & Therapeutics.
Losseff, M. S., et al. (2010). Alpha(1)-proteinase inhibitor (human). P&T.
MedlinePlus. (2022). Selective deficiency of IgA.
National Human Genome Research Institute. (2024). Antibody.
National Heart, Lung, and Blood Institute. (2023). Alpha-1 antitrypsin deficiency.
Patel, A., et al. (2023). Biochemistry, immunoglobulin A. StatPearls.
Takeda Pharmaceuticals Inc. (2023). Glassia dosage and administration guide.
Takeda Pharmaceuticals Inc. (2023). Glassia [package insert].
U.S. Food and Drug Administration. (2021). Safely using sharps (needles and syringes) at home, at work and on travel.
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