Important Safety Information
KALBITOR® (ecallantide) for subcutaneous use should only be given by a doctor or nurse with appropriate
medical support to treat serious allergic reactions and your hereditary angioedema. 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, nasal congestion 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. Tell your doctor about all the medicines you take, including prescription and over-the-counter
medicines, vitamins and herbal supplements.
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 the Full Prescribing Information,
including Boxed Warning and Medication Guide.
You are encouraged to report negative side effects of prescription drugs to the FDA.
or call 1-800-FDA-1088.