Data from FDA (Food and Drug Administration, USA) - Curated by Toby Galbraith - Last updated 25 May 2017

Indication(s)

GLASSIA is an alpha1-proteinase inhibitor that is indicated for chronic augmentation and maintenance therapy in adults with emphysema due to congenital deficiency of alpha1-proteinase inhibitor (Alpha1-PI), also known as alpha1-antitrypsin deficiency (1).
- The effect of augmentation therapy with any alpha1-proteinase inhibitor on pulmonary exacerbations and on the progression of emphysema in Alpha1-PI deficiency has not been demonstrated in randomized, controlled clinical trials (1).
- Clinical data demonstrating the long-term effects of chronic augmentation and maintenance therapy of individuals with GLASSIA are not available (1).
- GLASSIA is not indicated as therapy for lung disease in patients in whom severe Alpha1-PI deficiency has not been established (1).

Full Prescribing information

Learning Zones

An epgonline.org Learning Zone (LZ) is an area of the site dedicated to providing detailed self-directed medical education about a disease, condition or procedure.

Airway Disease

The Airway Disease Learning Zone is an area where you can access the information about VisionAir and see video presentations from the forum. The Inhalation Technology page features a video presentation from the live broadcast presented by key faculty.

Visit Airway Disease

Hyperammonaemia

Hyperammonaemia can result in serious neurological damage or death. Could you recognise the signs and symptoms?

Visit Hyperammonaemia

Related Content

Advisory information

contraindications

- IgA deficient patients with antibodies against IgA (4).
- History of severe immediate hypersensitivity reactions, including anaphylaxis, to Alpha1-PI products (4).

Special warnings and precautions

- IgA deficient patients with antibodies against IgA may develop severe hypersensitivity and anaphylactic reactions (5.1).
- May carry a risk of transmitting infectious agents such as viruses and theoretically, the Creutzfeldt-Jakob disease (CJD) agent, despite manufacturing steps designed to minimize the risk of viral transmission (5.2, 11).

Adverse reactions

The most common product-related adverse reactions (>3%) in clinical studies were headache and dizziness (6.1).

Usage information

Dosing and administration

- For intravenous use only (2).
- Do not mix with other agents or diluting solutions (2).
- Dose = 60 mg/kg body weight once weekly (2.1).
- Dose ranging studies using efficacy endpoints have not been performed (2.1).
- Use filter needle as indicated in the "Preparation" section (2.2).
- The infusion rate should not exceed 0.04 mL/kg body weight per minute (2.3).
- If adverse events occur, reduce the rate or interrupt the infusion until the symptoms subside. You may then resume the infusion at a rate tolerated by the patient (2.3).

Use in special populations
- Pregnancy: No human or animal data. Use only if clearly needed (8.1).

More information

Category Value
Authorisation number BLA125325
Orphan designation No
Product NDC 0944-2884
Date First Approved 31-05-2011
Marketing authorisation holder Baxalta US Inc.