Kalbitor

Acute attacks: Sudden attacks of hereditary angioedema.
Clinical trials: Studies that evaluate the effectiveness and safety of medications or medical devices before they are approved for use by the general public.
Ecallantide: A protein made in yeast cells; ecallantide is the active ingredient in KALBITOR.
HAE: Abbreviation for hereditary angioedema.
Hereditary Angioedema: A rare, hereditary disease of the immune system that causes attacks of sudden swelling in various parts of the body.
KALBITOR: A prescription medicine used to treat sudden attacks of hereditary angioedema in patients 16 years of age and older. KALBITOR is not a cure for HAE.
KALBITOR Access: KALBITOR Access is a program that provides support services to hereditary angioedema patients, healthcare professionals and caregivers. KALBITOR Access services include health insurance coordination, financial assistance for qualified patients and treatment location set up.
Laryngeal attack: An HAE attack that affects the larynx (throat); this can block or close the airway, leading to difficulty breathing and, potentially, death.
Larynx: The part of the throat that contains the vocal cords and is used for breathing, swallowing, and talking.
Mean Symptom Complex Severity: Patient reported measurement of efficacy. Also known as MSCS score, a point-in-time measure of symptom severity. At baseline, 4 hours, and 24 hours, patients rated the severity on a categorical scale (0 = normal, 1 = mild, 2 = moderate, 3 = severe) for symptoms at each affected anatomical location. Ratings were averaged to obtain the MSCS score. A decrease in MSCS score reflected an improvement in symptoms.
MSCS: Mean Symptom Complex Severity. MSCS score is a point-in-time measure of symptom severity. At baseline, 4 hours, and 24 hours, patients rated the severity on a categorical scale (0 = normal, 1 = mild, 2 = moderate, 3 = severe) for symptoms at each affected anatomical location. Ratings were averaged to obtain the MSCS score. A decrease in MSCS score reflected an improvement in symptoms.
Plasma kallikrein: A protein in the body that triggers the release of a substance that may lead to hereditary angioedema attack symptoms.
Subcutaneous: Under the skin.
TOS: Treatment Outcome Score, patient reported measurement of efficacy. TOS is a measure of symptom response to treatment. At 4 hours and 24 hours, patient assessment of response, characterized by their change from baseline in symptom severity and collected by anatomic site of attack involvement, was recorded on a categorical scale (significant improvement [100], improvement [50], same [0], worsening [-50], significant worsening [-100]). The response at each anatomic site was weighted by baseline severity, and then the weighted scores across all involved sites were averaged to calculate the TOS. A TOS value >0 reflected an improvement in symptoms from baseline.
Treatment Outcome Score: Patient-reported measurement of efficacy. Also known as TOS, a measure of symptom response to treatment. At 4 hours and 24 hours, patient assessment of response, characterized by their change from baseline in symptom severity and collected by anatomic site of attack involvement, was recorded on a categorical scale (significant improvement [100], improvement [50], same [0], worsening [-50], significant worsening [-100]). The response at each anatomic site was weighted by baseline severity, and then the weighted scores across all involved sites were averaged to calculate the TOS. A TOS value >0 reflected an improvement in symptoms from baseline.
Trigger: In hereditary angioedema, something that causes an attack.

The information contained in this section of the site is intended for U.S. healthcare professionals only.

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KALBITOR^® (ecallantide)

KALBITOR is the first subcutaneous treatment approved for all HAE attack locations in patients 16 years of age and older.

Approval based on results from two placebo-controlled phase 3 clinical studies that included:

64 patients with abdominal attacks
55 with peripheral attacks
24 with laryngeal attacks

Please see Full Prescribing Information, including Boxed Warning and Medication Guide.

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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.

CONTRAINDICATIONS

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.