KALBITOR® (ecallantide) is indicated for treatment of acute attacks of hereditary angioedema (HAE) in patients 12 years of age and older.
Important Safety Information
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. See Full Prescribing Information.
Takeda’s OnePath program helps patients navigate insurance access and coverage issues. Patient Support Managers can help your patients understand their coverage for KALBITOR and provide information about financial assistance options. In addition to supplying information about third-party and charitable organizations that may provide financial assistance to HAE patients for their medical care, OnePath offers a co-pay assistance option to eligible patients.
OnePath Co-Pay Assistance Program*
Adolescents and adults who have commercial insurance may be eligible to enroll in the OnePath Co-Pay Assistance Program.* This program may help cover the cost of insurance co-pays for KALBITOR at 100%, up to the program maximum, for those who are eligible.
Important Safety Information
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 HAE.
Healthcare professionals should be aware of similarity of symptoms between hyper sensitivity reactions and HAE patients should be monitored closely.
Do not administer KALBITOR to patients with known clinical hypersensitivity to KALBITOR.
CONTRAINDICATIONS
Do not administer KALBITOR to a patient who has known clinical hypersensitivity to KALBITOR
WARNINGS AND PRECAUTIONS: Hypersensitivity Reactions, Including Anaphylaxis
Potentially serious hypersensitivity reactions, including anaphylaxis, have occurred in patients treated with 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 hypersensitivity reactions have included chest discomfort, flushing, pharyngeal edema, pruritus, rhinorrhea, sneezing, nasal congestion, throat irritation, urticaria, wheezing, and hypotension.
Other adverse reactions indicative of hypersensitivity reactions included the following: pruritus (5%), rash (3%), and urticaria (2%).
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.
ADVERSE REACTIONS
The most common adverse reactions (≥3% and greater than placebo) in HAE patients were headache (8%), nausea (5%), diarrhea (4%), pyrexia (4%), injection site reactions (3%), and nasopharyngitis (3%).
There is a potential for immunogenicity with the use of KALBITOR. Overall, 20.2% of patients seroconverted to anti-ecallantide antibodies. Patients who seroconvert may be at a higher risk of a hypersensitivity reaction. The long-term effects of antibodies to KALBITOR are not known.
