Treating HAE Attacks with KALBITOR

KALBITOR (ecallantide) is an under the skin (subcutaneous),
on-demand treatment for hereditary angioedema (HAE) attacks that targets and inhibits plasma kallikrein, which stops the production of bradykinin to reduce the pain and swelling of an HAE attack.

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

Common Questions

Below are some questions you may ask when considering KALBITOR (ecallantide). Make sure to ask your doctor if KALBITOR is right for you.

  • Q.

    What is KALBITOR?

    A.

    KALBITOR is a prescription medicine used to treat hereditary angioedema (HAE) attacks and is approved for people 12 years of age or older. KALBITOR is not a cure for HAE.

  • Q.

    Can KALBITOR treat symptoms of an HAE attack anywhere in the body?

    A.

    KALBITOR was studied in people with abdominal attacks, laryngeal attacks (throat), and peripheral attacks (typically face, hands, genitals, and feet).

  • Q.

    What can I expect from KALBITOR treatment?

    A.

    In clinical trials, people treated with KALBITOR had a significant improvement in HAE attack symptoms at 4 hours after administration. Individual results may vary.

  • Q.

    What are the possible side effects of KALBITOR?

    A.

    Some people who receive KALBITOR may experience serious allergic reactions, which can be life-threatening. These reactions usually occur within 1 hour after receiving KALBITOR. Your doctor or nurse should watch you for any signs of a serious allergic reaction after treatment with KALBITOR. Other side effects of KALBITOR may include headache, nausea, diarrhea, fever, injection site reactions, such as redness, rash, swelling, itching, or bruising, and stuffy nose.

  • Q.

    Is there important safety information that I should know about KALBITOR?

    A.

    KALBITOR is not approved for self-administration and should only be given by a doctor or nurse with appropriate medical support to manage serious allergic reactions and HAE. Symptoms of a serious allergic reaction to KALBITOR can be similar to HAE, 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, nasal congestion or sneezing
  • Q.

    Who should not receive KALBITOR?

    A.

    People with HAE who are allergic to KALBITOR should not receive KALBITOR.

  • Q.

    What is KALBITOR made of?

    A.

    The active ingredient in KALBITOR is ecallantide, a small protein made in yeast cells. Inactive ingredients include disodium hydrogen orthophosphate (dihydrate), monopotassium phosphate, potassium chloride, sodium chloride in water for injection.

  • Q.

    How is KALBITOR given?

    A.

    For each dose, your doctor or nurse will inject KALBITOR just under your skin (subcutaneously) away from the site of the attack into the abdomen, thigh, or upper arm.

  • Q.

    What should I tell my doctor before I receive KALBITOR?

    A.

    Before receiving KALBITOR, tell your doctor if you:

    • have ever had an allergic reaction to KALBITOR
    • are pregnant or plan to become pregnant; it is not known if KALBITOR will harm your unborn baby
    • are breastfeeding or plan to breast feed; it is not known if KALBITOR passes into breast milk

    Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Know the medicines you take. Keep a list of them to show to your doctor and pharmacist when you get a new medicine.

  • Q.

    If my doctor prescribes KALBITOR, what's the next step?

    A.

    If your doctor prescribes KALBITOR, and you're eligible for OnePath®, a Patient Support Manager will contact you to help you with your access to treatment, including assisting you with questions about health insurance coverage. Find out more about OnePath.

  • Q.

    What is OnePath?

    A.

    OnePath provides a variety of product support services to eligible KALBITOR patients, such as communicating health insurance benefits to patients, providing information about financial assistance options, and site of care coordination. Each patient works with a dedicated Patient Support Manager who can answer questions and help coordinate access to KALBITOR.

  • Q.

    How can I receive KALBITOR treatment when I travel?

    A.

    You should contact your OnePath Patient Support Manager, who may be able to arrange an alternate treatment site location.

  • Q.

    Why does a doctor or nurse have to administer KALBITOR?

    A.

    Because of the risk of serious, potentially life-threatening allergic reactions, KALBITOR must be administered by a healthcare professional who can monitor your response to treatment and recognize the signs of an allergic reaction. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show to your doctor and pharmacist when you get a new medicine.

Important Safety Information

What is the most important information I should know about KALBITOR?
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.

  • KALBITOR should be given to you by a doctor or nurse in a healthcare setting where serious allergic reactions and hereditary angioedema (HAE) can be treated.
  • Symptoms of a serious allergic reaction to KALBITOR can be similar to the symptoms of HAE, 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, nasal congestion, or sneezing

Who should not receive KALBITOR?
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.

What else should I tell my doctor before I receive KALBITOR?
Tell your doctor if you are pregnant, plan to become pregnant, breast-feeding, or plan to breast-feed. It is not known if KALBITOR will harm your unborn baby or pass into your breast milk.

Tell your doctor about all the medicines you take, including prescriptions and over-the-counter medicines, vitamins, and herbal supplements.

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

Talk to your doctor for more information about your medical condition or treatment.

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