Important Safety Information
Berinert®, C1 Esterase Inhibitor (Human), is a plasma-derived C1 Esterase Inhibitor (Human), indicated for the treatment of acute abdominal, facial or laryngeal attacks of hereditary angioedema (HAE) in adult and pediatric patients. The safety and efficacy of Berinert for prophylactic therapy have not been established.
Berinert is contraindicated in individuals with a history of life-threatening immediate hypersensitivity reactions, including anaphylaxis, to C1 esterase inhibitor preparations.
Monitor patients for early signs of allergic or hypersensitivity reactions (including hives, generalized urticaria, chest tightness, wheezing, hypotension, and anaphylaxis). If hypersensitivity is suspected, immediately discontinue administration of Berinert and initiate appropriate treatment. Epinephrine should be immediately available for treatment of acute severe hypersensitivity reactions.
Serious arterial and venous thromboembolic (TE) events have been reported at recommended doses of C1 Esterase Inhibitor (Human) products, including Berinert, following administration to patients with HAE. Risk factors may include having an indwelling venous catheter/access device; prior history of thrombosis; underlying atherosclerosis; use of oral contraceptives or certain androgens; morbid obesity; and immobility. Weigh benefits/risks before administering to patients with known risk factors for TE events and closely monitor such patients during and after Berinert administration. TE events have also been reported with C1 Esterase Inhibitor (Human) products when used for unapproved indications at higher than recommended doses.
Appropriately trained patients may self-administer Berinert upon recognition of an HAE attack. Advise patients to seek medical attention immediately following self-administration for laryngeal attacks, and to seek medical attention if progress of any attack makes them unable to properly prepare or administer dose of Berinert.
Berinert is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.
The most serious adverse reaction reported in subjects who received Berinert in clinical studies was an increase in the severity of pain associated with HAE. Dysgeusia was the most common adverse reaction reported in over 4% of subjects and more frequently than in the placebo group.
Berinert has not been evaluated in pregnant women or nursing mothers, and should be used only if clearly needed. In clinical trials, the half-life of Berinert was shorter and clearance was faster in children than in adults; the clinical implication of this difference is not known.
Please see full prescribing information for Berinert, including the patient product information.