GLASSIA: Utilizare, Dozaj, Efecte adverse și Măsuri de precauție

If you’ve been diagnosed with emphysema (a lung disease) or are experiencing symptoms similar to emphysema due to alpha-1 antitrypsin deficiency (AATD), your healthcare provider may prescribe a medication called GLASSIA. 

GLASSIA, also known by its generic name, alpha-1 proteinase inhibitor (Alpha 1-PI), was approved by the FDA on July 1, 2010, for AATD. This medication replaces the missing Alpha 1-PI in adults with AATD and helps prevent further lung damage. 

Read on to learn important details about this drug, such as its usage, dosage, working mechanisms, associated side effects, warnings, and precautionary measures. 

GLASSIA Indication and Usage

GLASSIA is FDA-approved for chronic augmentation and maintenance therapy in adults who have emphysema due to severe hereditary deficiency of alpha-1 proteinase inhibitor.

Nota: Alpha-1 proteinase inhibitor (Alpha 1-PI) and alpha-1 antitrypsin (AAT) are both terms that refer to the same protein. 

Composition and Mechanism of Action

GLASSIA is made from human plasma (the liquid part of the blood), which contains alpha-1 proteinase inhibitor protein. 

Normally, alpha 1-PI or ATT protein protects the lungs by stopping the activity of an enzyme (a protein) called neutrophil elastase, which kills bacteria in the lungs. However, in people with AAT deficiency, elastase doesn’t stop working and eventually damages the lungs. This typically leads to emphysema, which causes symptoms like shortness of breath, wheezing, and chronic cough. 

• Mechanism of Action

GLASSIA works by raising the alpha-1 PI levels in the bloodstream. This helps lower inflammation and prevent further damage to lung tissue, thus slowing down the worsening of lung disease. 

Nota: GLASSIA is not a cure for AAT deficiency; it only helps to manage the condition and slow down or prevent further lung damage. 

Dosage and Administration

GLASSIA is available as a single-dose vial containing approximately 1 gram (1,000 mg) of functional Alpha-1 PI in 50 ml of ready-to-use solution. This liquid medication is administered through intravenous (IV) infusions once a week. 

The recommended dosage of GLASSIA is 60 mg/kg of body weight, which is infused at a rate of 0.2 ml per kg per minute. The infusion takes approximately 15 minutes.

The dosage of GLASSIA is based on your body weight; your dose may change if you lose or gain weight. 

GLASSIA: Side Effects

The most common side effects are headaches and upper respiratory tract infections. Other possible side effects of GLASSIA include:

• Tuse
• Sinus infection
• Chest discomfort
• Ameţeală
• Increased liver enzymes
• Dificultăți de respirație
• Greaţă
• Oboseală

The serious side effects observed during clinical trials include:

• Worsening or flare-up of chronic obstructive pulmonary disease (COPD)

Get medical help immediately if you notice signs of an allergic reaction to GLASSIA. Common signs include:

• Hives and rash
• Swelling in the mouth or throat
• Itching
• Chest discomfort
• Trouble breathing and wheezing
• Fainting or dizziness

Your healthcare provider may prescribe epinephrine or provide other supportive care for certain severe allergic reactions. 

GLASSIA: Contraindications and Warnings

GLASSIA is contraindicated in patients who have:

• Immunoglobulin A (IgA) deficiency with antibodies against IgA
• A history of severe allergic reaction to alpha 1-PI products
• Active lung infections

Furthermore, you may get an infection from GLASSIA. Although this medication is made from human blood and undergoes a rigorous testing and screening process, there is still a chance that it might contain infectious agents such as viruses, the variant Creutzfeldt-Jakob disease (vCJD), and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

Precautionary Measures

Before opting for GLASSIA, tell your healthcare provider if you are/have:

• Pregnant or plan to become pregnant because it is not known whether GLASSIA can cause harm to an unborn baby.
• Breastfeeding or plan to breastfeed because there is no information on the effect Glassia may have on breastfed infants or milk production 
• Taking any over-the-counter medications, supplements, or herbal products
• Any health problem like liver disease, chronic obstructive pulmonary disease (COPD), or other breathing problems

Estimated Cost

One single-use vial of GLASSIA (for intravenous use) typically costs around $10. But the cost could differ depending on your pharmacy. 

Alternatives to GLASSIA

Your healthcare provider might prescribe other medications in place of GLASSIA. Some possible alternatives are Aralast, Aralast NP, Zemaira, and Prolastin. Talk to your healthcare provider about which medication is best for you.

Frequently Asked Questions (FAQs)

1. Can GLASSIA cure AATD? 

No, it does not cure AATD; it only helps slow the progression of lung disease by increasing the levels of alpha-1 antitrypsin protein (AAT) in the blood and lungs. There currently isn’t a cure for AATD.

2. How long do I need to take GLASSIA?

AATD is a lifelong condition, so treatment with GLASSIA is ongoing. Your healthcare provider will likely have you continue taking GLASSIA as long as it’s helping your condition and you’re not having any significant side effects. Talk to your healthcare provider if you have questions or concerns about your GLASSIA treatment. 

3. Can I receive this medication at home? 

Yes, many patients receive GLASSIA at home after proper training or with the help of a nurse. But your healthcare provider will likely have you receive the first few doses in a clinic or infusion center. GLASSIA comes in a ready-to-administer formulation, so you don’t need to mix anything before infusion. 

4. Is GLASSIA the same as other AAT therapies? 

GLASSIA is similar to other Alpha 1-PI therapies like Prolastin-C, Aralast NP, and Zemaira. Still, it is unique because it is a ready-to-use liquid rather than a powder that requires mixing.

5. What should I do if I miss a dose? 

If you miss a dose, contact your healthcare provider for further instructions. Do not double the next dose to make up for the missed one. 

6. Is this medication FDA-approved?

Yes, GLASSIA is FDA-approved. The 1-gram vial size was approved by the FDA in 2010, and the new larger vial sizes (4 and 5 grams) will be available beginning July 2025. 

7.  Is GLASSIA a biologic?

Yes, it (Alpha1-Proteinase Inhibitor [Human]) is a biologic, meaning it’s made from human blood plasma. 

8. What is the maximum infusion rate?

The maximum recommended infusion rate for GLASSIA is 0.2 ml/kg/min. Your infusion should only take approximately 15 minutes at the recommended dose and maximum infusion rate.