GLASSIA® [Alpha1-Proteinase Inhibitor (Human)]

IGLASSIA® is a brand-name medication that contains Alpha1-Proteinase Inhibitor (Human). It is primarily used to treat individuals with alpha-1 antitrypsin deficiency (AATD), a genetic disorder that can lead to lung and liver problems. GLASSIA® is a sterile, highly purified preparation of human Alpha1-Proteinase Inhibitor. It is used to augment or replace the deficient or dysfunctional Alpha1-proteinase inhibitor in individuals with AATD.

Indications and Uses 

GLASSIA® is indicated for the following purposes:

• Treatment of individuals with alpha-1 antitrypsin deficiency (AATD) to raise the level of functional AAT in the blood and lungs.

• It is used to help prevent or slow down the progression of lung damage associated with AATD.

• The product has limited data on its use for other medical conditions.

Dosage and Administration

The dosage of GLASSIA® is determined by a healthcare provider based on the patient's specific condition and AAT levels. The medication is administered through intravenous (IV) infusion. The dose and frequency of administration are individualized to the patient's needs.

Contraindications

GLASSIA® should not be used in individuals with known hypersensitivity to Alpha1-Proteinase Inhibitor (Human) or any of its components. It is essential to discuss any allergies or potential reactions with a healthcare provider.

Adverse Effects and Side Effects

Common side effects of GLASSIA® may include:

• Headache.

• Fatigue.

• Dizziness.

• Rash.

• Nausea.

Serious side effects are rare but may include:

• Anaphylactic or severe allergic reactions, which can manifest as hives, difficulty breathing, and swelling of the face, lips, or tongue.

• Formation of immune complexes in the blood.

It is crucial to report any severe or unusual side effects to your healthcare provider.

Storage and Shelf Life

Store GLASSIA® at room temperature (20-25°C or 68-77°F). Protect it from excessive heat. Do not use GLASSIA® after the expiration date.

Packaging and Presentation

GLASSIA® is available as a sterile, white, lyophilized powder in a single-use vial for reconstitution before IV infusion.

Regulatory Information

GLASSIA® is subject to regulation by health authorities to ensure its safety and efficacy. It is essential to use this medication as directed by a healthcare professional and in accordance with local regulations.

References

Always consult with your healthcare provider and refer to the official prescribing information and product labeling for the most up-to-date and comprehensive information on GLASSIA®. Your healthcare provider will guide you in the proper use of this medication, monitor your progress, and tailor the treatment to your specific medical condition.