IMPORTANT SAFETY INFORMATION FOR HEALTHCARE PROFESSIONALS
Risk Evaluation and Mitigation Strategy (REMS)
A Risk Evaluation and Mitigation Strategy (REMS) is a strategy to manage known or potential serious risks associated with a drug product and is required by the Food and Drug Administration to ensure that the benefits of the drug outweigh its risks.
In order for Dyax to communicate certain risks to ensure that KALBITOR is prescribed and taken safely, Dyax has worked with the FDA to develop materials to communicate the risk of anaphylaxis and the importance of distinguishing between hypersensitivity reactions and ongoing hereditary angioedema (HAE) symptoms. The REMS program is designed to inform healthcare providers and patients about the potential risks with KALBITOR. To learn more about serious risks, read the important safety information provided in this link, including the Medication Guide, and discuss it with your patients.
The goals of the KALBITOR REMS are:
- To inform healthcare providers about the risk of anaphylaxis associated with KALBITOR and the importance of distinguishing between a hypersensitivity reaction and hereditary angioedema (HAE) attack symptoms.
- To educate patients about the serious risks associated with KALBITOR therapy.
To download the REMS documents:
WARNING: Anaphylaxis
Anaphylaxis has been reported after administration of KALBITOR®. Because of the risk of anaphylaxis, KALBITOR should only be administered by a healthcare professional with appropriate medical support to manage anaphylaxis and hereditary angioedema. Healthcare professionals should be aware of the similarity of symptoms between hypersensitivity reactions and hereditary angioedema and patients should be monitored closely. Do not administer KALBITOR to patients with known clinical hypersensitivity to KALBITOR.
CONTRADICTIONS
Do not administer KALBITOR to a patient who has known clinical hypersensitivity to KALBITOR.
WARNINGS AND PRECAUTIONS
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.
ADVERSE EVENTS
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.
USAGE
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 the 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.
