Read this Medication
Guide before you start receiving KALBITOR and before each treatment.
There may be new information. This Medication Guide does not take
the place of talking to your doctor about your medical condition or
What is the most important information that I should know
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 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
- wheezing, shortness of breath, cough, chest tightness, or
- dizziness, fainting, fast or weak heartbeat, or feeling
- 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
KALBITOR is a prescription
medicine used to treat sudden attacks of hereditary angioedema (HAE)
in people 12 years of age and older.
KALBITOR is not a
cure for HAE.
It is not known if KALBITOR is safe and
effective in children under 12 years of age.
Who should not receive KALBITOR?
Do not receive KALBITOR if you are allergic to
What should I tell my doctor before I receive KALBITOR?
Before receiving KALBITOR, tell your doctor if
- have ever had an allergic reaction to KALBITOR. See “Who
should not receive KALBITOR?”
- are pregnant or plan to become pregnant. It is not known
if KALBITOR will harm your unborn baby.
- are breast-feeding or plan to breast-feed. It is not known
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.
medicines you take. Keep a list of them to show to your doctor and
pharmacist when you get a new medicine.
How will I receive KALBITOR?
For each dose, you will receive 3 injections just
under the skin (subcutaneous or SC injections) of your abdomen, thigh,
or upper arm.
What are the possible side effects?
can cause serious allergic reactions. See ("What
is the most important information I should know about KALBITOR?").
Common side effects of KALBITOR
- injection site reactions, such as redness, rash, swelling,
itching, or bruising
- stuffy nose
Call your doctor for advice
about side effects. You may report side effects to FDA at 1‑800-FDA-1088.
Medicines are sometimes
prescribed for purposes other than those listed in a Medication Guide.
This Medication Guide gives you the most important information about
KALBITOR. If you would like more information, talk with your doctor.
You can ask your pharmacist or doctor for information about KALBITOR
that is written for health professionals.
What are the ingredients of
Active Ingredient: ecallantide
Inactive ingredients: disodium
hydrogen orthophosphate (dihydrate), monopotassium phosphate, potassium
chloride, sodium chloride in water for injection.
This Medication Guide has been approved by
the U.S. Food and Drug Administration.
Manufactured for: Dyax Corp.
Network Drive, Burlington, MA 01803
U.S. License No. 1789