Important Safety Information
Berinert®, C1 Esterase Inhibitor (Human), is a plasma-derived concentrate of C1 Esterase Inhibitor (Human), indicated for the treatment of acute abdominal, facial or laryngeal attacks of hereditary angioedema (HAE) in adult and adolescent 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 systemic reactions to C1 esterase inhibitor preparations (including anaphylaxis).
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.
Thrombotic events have been reported in patients receiving C1 esterase inhibitor products, including Berinert, at the recommended dose as well as when used off-label or at higher-than-labeled doses. Closely monitor patients with risk factors for thrombotic events.
Patients able to recognize signs and symptoms of HAE attack and comprehend necessary training can self-administer Berinert. Patients should not attempt to self-administer unless they have been trained and determined to be capable by healthcare provider. Advise patients to immediately seek medical attention 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. The safety and efficacy of Berinert have not been established in children (ages 0 through 12) or in the geriatric population. In clinical trials, the half-life of Berinert was shorter and clearance was faster in children than in adults; the clinical implication is not known.
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