Resources & Events

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.

Resources & Events

To help you learn more about KALBITOR and hereditary angioedema (HAE), there are a number of resources available to you:

It is important to keep in touch with your doctor, don’t hesitate to ask questions or express your concerns regarding your HAE treatment.

If your doctor prescribes KALBITOR, KALBITOR Access is an important resource for information, support and any concerns you might have with starting on the KALBITOR therapy. Call toll free at 1-888-4KALBITOR (1-888-452-5248) if you have any questions about KALBITOR.

Important Safety Information

KALBITOR^® (ecallantide) for subcutaneous use should only be given by a doctor or nurse in a healthcare setting where serious allergic reactions and your hereditary angioedema can be treated. You should read the Medication Guide before you start receiving KALBITOR and before each treatment.

Serious allergic reactions may happen in some people who receive KALBITOR. These allergic reactions can be life-threatening and usually happen within 1 hour after receiving KALBITOR.

Symptoms of a serious allergic reaction to KALBITOR can be similar to the symptoms of hereditary angioedema, the condition that you are being treated for. Your doctor or nurse should watch you for any signs of a serious allergic reaction after treatment with KALBITOR. Tell your doctor or nurse right away if you have any of these symptoms of a serious allergic reaction during or after treatment with KALBITOR:

wheezing, shortness of breath, cough, chest tightness, or trouble breathing
dizziness, fainting, fast or weak heartbeat, or feeling nervous
reddening of the face, itching, hives, or feeling warm
swelling of the throat or tongue, throat tightness, hoarse voice, or trouble swallowing
runny nose or sneezing

Do not receive KALBITOR if you are allergic to KALBITOR. Before receiving KALBITOR, tell your doctor if you have ever had an allergic reaction to KALBITOR.

Before receiving KALBITOR, tell your doctor about all of your health conditions, including any allergies you may have, whether you are pregnant, plan to become pregnant, or are breast feeding or plan to breast feed. It is not known if KALBITOR will harm your unborn baby or if KALBITOR passes into your breast milk.

Common side effects of KALBITOR include headache, nausea, diarrhea, fever, injection site reactions, such as redness, rash, swelling, itching, or bruising, and stuffy nose.

Talk to your doctor for more information and if you have any questions about your treatment.

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

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

kalbitor ecallantide

Resources & Events

Important Safety Information