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.

Risks and Side Effects

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 hereditary angioedema (HAE). Please read the Medication Guide before you start receiving KALBITOR and before each treatment. There may be new information.

Allergic Reactions

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.

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

You should 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.

Common Side Effects of KALBITOR Include:

  • headache
  • nausea
  • diarrhea
  • fever
  • injection site reactions, such as redness, rash, swelling, itching, or bruising
  • stuffy nose

Call your doctor for advice about side effects of KALBITOR.

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.

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

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.