Data from FDA - Curated by Toby Galbraith - Last updated 21 April 2017
FDA (Food and Drug Administration, USA)
• Do not use in patients with a history of life-threatening immediate hypersensitivity reactions, including anaphylaxis, to C1 esterase inhibitor preparations (4).
• Hypersensitivity reactions may occur. Epinephrine should be immediately available to treat any acute severe hypersensitivity reactions following discontinuation of administration (5.1).
• Serious arterial and venous thromboembolic (TE) events have been reported at the recommended dose of C1 Esterase Inhibitor (Human) products, including Berinert, following administration in patients with HAE. Risk factors may include the presence of an indwelling venous catheter/access device, prior history of thrombosis, underlying atherosclerosis, use of oral contraceptives or certain androgens, morbid obesity, and immobility. Benefits of treatment of HAE attacks should be weighed against the risks of TE in patients with underlying risk factors. Monitor patients with known risk factors for TE events during and after Berinert administration.
TE events have been reported following administration of a C1 Esterase Inhibitor (Human) product when used off-label at higher than labeled doses.1 (5.2).
• Berinert is made from human plasma and may contain infectious agents, eg, viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent (5.3).
• Laryngeal attacks: Following self-administration of Berinert for laryngeal attacks, advise patients to immediately seek medical attention (5.4).
• The most serious adverse reaction reported in subjects who received Berinert was an increase in the severity of pain associated with HAE (6.1).
• The most common adverse reaction reported in greater than 4% of the subjects and greater than placebo among subjects who received Berinert in the placebo-controlled clinical trial was dysgeusia (6.1).
• Store the vial in the original carton in order to protect from light. Store at 2-25°C (36-77°F). Do not freeze (2).
• Administer 20 International Units per kg body weight (2).
• Reconstitute Berinert prior to use using the Sterile Water for Injection, USP provided (2.1).
• Administer at room temperature within 8 hours of reconstitution (2.1).
• Inject at a rate of approximately 4 mL per minute (2.2).
• Do not mix Berinert with other medicinal products or solutions (2.2).
• Appropriately trained patients may self-administer upon recognition of an HAE attack (2.2).
• Compared to adults, when adjusted for baseline, the half-life of Berinert was shorter and clearance (on per kg basis) was faster in children. The clinical implication of this difference is not known (12.3).
|Date First Approved||22-12-2011|
|Marketing authorisation holder||CSL Behring GmbH|