Data from FDA (Food and Drug Administration, USA) - Curated by Marshall Pearce - 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

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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.