FDA (Food and Drug Administration, USA)
- IgA deficient patients with antibodies against IgA (4).
- History of severe immediate hypersensitivity reactions, including anaphylaxis, to Alpha1-PI products (4).
- 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).
The most common product-related adverse reactions (>3%) in clinical studies were headache and dizziness (6.1).
- 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).
|Date First Approved||31-05-2011|
|Marketing authorisation holder||Baxalta US Inc.|