Resources You Need
KALBITOR CareSM connects healthcare professionals with educational resources about hereditary angioedema (HAE).
Please see Full Prescribing Information, including Boxed Warning and Medication Guide.
KALBITOR CareSM connects healthcare professionals with educational resources about hereditary angioedema (HAE).
Please see Full Prescribing Information, including Boxed Warning and Medication Guide.
Dyax Corp. offers these resources to help you better understand hereditary angioedema (HAE) and to provide more information about KALBITOR on-demand treatment for acute HAE attacks.
We invite you to download the following information for your practice and your patients:
You can request that a Dyax Corp. representative contact you to discuss any questions you may have about on-demand treatment with KALBITOR or the accompanying support of KALBITOR Care. Schedule your call.
To request additional medical information, please contact KALBITOR Access at 1-888-4KALBITOR (1-888-452-5248).
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Please make sure to read
Important Safety
Information for KALBITOR.
Learn how KALBITOR Care can help you prepare a treatment plan for your patient’s next acute HAE attack.
Learn MoreQuestions about KALBITOR? Request a call from a Dyax Corp. representative for more information.
request a callDo 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 (3.9%) experienced anaphylaxis. For the subgroup of 187 patients treated with subcutaneous KALBITOR, 5 patients (2.7%) 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 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. Patients who seroconvert may be at a higher risk of 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 16 years of age have not been established.
Please see Full Prescribing Information, including Boxed Warning and Medication Guide.
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.