Important Safety Information
- Anaphylaxis has been reported after administration of KALBITOR.
Because of the risk of anaphylaxis, KALBITOR should only be administered by a
professional with appropriate medical support to manage anaphylaxis and HAE.
Healthcare professionals should be aware of the similarity of symptoms between
reactions and HAE and patients should be monitored closely.
Do not administer KALBITOR to patients with known clinical hypersensitivity to
Do not administer KALBITOR to a patient who has known clinical hypersensitivity to
WARNINGS AND PRECAUTIONS
In 255 HAE patients treated with intravenous or subcutaneous KALBITOR in clinical trials, 10
(4%) experienced anaphylaxis. For the subgroup of 187 patients treated with subcutaneous
5 patients (3%) experienced anaphylaxis. These reactions occurred within the first hour
Symptoms associated with these reactions have included chest discomfort, flushing,
pruritus, rhinorrhea, sneezing, nasal congestion, throat irritation, urticaria, wheezing,
Patients should be observed for an appropriate period of time after administration of
into account the time to onset of anaphylaxis seen in clinical trials. Given the similarity
symptoms and acute HAE symptoms, patients should be monitored closely in the event of a
The most common adverse events (≥3% and greater than placebo) in HAE patients were headache,
diarrhea, pyrexia, injection site reactions, and nasopharyngitis.
There is a potential for immunogenicity with the use of KALBITOR. Overall, 20.2% of patients
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.
Please see the Full Prescribing
Information, including Boxed
Warning and Medication Guide.
Healthcare professionals should report all suspected adverse events associated with the use
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