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Do not administer KALBITOR to a patient who has known clinical hypersensitivity to KALBITOR.
In 255 HAE patients treated with intravenous or subcutaneous KALBITOR in clinical trials, 10 patients (4%) experienced anaphylaxis. For the subgroup of 187 patients treated with subcutaneous KALBITOR, 5 patients (3%) experienced anaphylaxis. These reactions occurred within the first hour after dosing.
Symptoms associated with these reactions have included chest discomfort, flushing, pharyngeal edema, pruritus, rhinorrhea, sneezing, nasal congestion, throat irritation, urticaria, wheezing, and hypotension.
Patients should be observed for an appropriate period of time after administration of KALBITOR, taking into account the time to onset of anaphylaxis seen in clinical trials. Given the similarity in hypersensitivity symptoms and acute HAE symptoms, patients should be monitored closely in the event of a hypersensitivity reaction.
The most common adverse events (≥3% and greater than placebo) in HAE patients were headache, nausea, diarrhea, pyrexia, injection site reactions, and nasopharyngitis.
There is a potential for immunogenicity with the use of KALBITOR. Overall, 20.2% of patients seroconverted to anti-ecallantide antibodies. Anti-ecallantide IgE antibodies were detected at a rate of 4.7% for tested patients, and anti-P. pastoris IgE antibodies were also detected at a rate of 20.2%. Patients who seroconvert may be at a higher risk of a hypersensitivity reaction. The long-term effects of antibodies to KALBITOR are not known.
KALBITOR should only be administered by a healthcare professional with appropriate medical support to manage anaphylaxis and hereditary angioedema. Safety and effectiveness of KALBITOR in patients below 12 years of age have not been established.
Healthcare professionals should report all suspected adverse events associated with the use of KALBITOR. Please contact Dyax Corp. at 1-888-452-5248. Alternatively, this information may be reported to the FDA MedWatch System by phone at 1-800-FDA-1088, or by mail using Form 3500 at www.fda.gov/medwatch.