KALBITOR DX-88 Ecallantide Injection User Guide
- August 17, 2024
- KALBITOR
Table of Contents
KALBITOR DX-88 Ecallantide Injection
Specifications
- Product Name: KALBITOR
- Active Ingredient: ecallantide (DX-88)
- Usage: Treatment of sudden attacks of hereditary angioedema (HAE)
- Age Restriction: Not recommended for children under 16 years of age
- Administration: Subcutaneous injections
Product Usage Instructions
Important Information
KALBITOR is used to treat sudden attacks of hereditary angioedema (HAE). It should only be administered by a healthcare professional in a setting equipped to handle serious allergic reactions.
Before Receiving KALBITOR
Prior to receiving KALBITOR, inform your doctor if you have allergies to the medication, are pregnant or breastfeeding, or are taking any other medications or supplements.
Administration:
For each dose, you will receive 3 subcutaneous injections just under the skin in your abdomen, thigh, or upper arm.
Possible Side Effects:
Common side effects of KALBITOR include allergic reactions. Contact your doctor for advice on managing side effects and report any adverse effects to the FDA.
FAQ
Q: What is KALBITOR used for?
A: KALBITOR is used to treat sudden attacks of hereditary angioedema (HAE).
Q: How is KALBITOR administered?
A: KALBITOR is administered through 3 subcutaneous injections just under the skin in the abdomen, thigh, or upper arm.
Q: What should I do in case of a serious allergic reaction to KALBITOR?
A: Notify your doctor or nurse immediately if you experience symptoms like difficulty breathing, itching, hives, or trouble swallowing.
DX-88 (ecallantide)
1.14.1.3 Draft Label – KALBITOR
27 November 2009
Medication Guide
KALBITOR® (KAL-bi-tor) ( ecallantide)
Read this Medication Guide before you start receiving K.ALBITOR 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 your
treatment.
What is the most important information that I should know about KALBITOR?
Serious allergic reactions may happen in some people who receive K.ALBITOR.
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 or sneezing
What is KALBITOR?
KALBITOR is a prescription medicine used to treat sudden attacks of hereditary
angioedema (HAE).
K.ALBITOR is not a cure for HAE.
It is not known if K.ALBITOR is safe and effective in children under 16 years
of age.
Who should not receive KALBITOR?
Do not receive KALBTTOR if you are allergic to KALBITOR.
What should I tell my doctor before I receive KALBITOR?
Before receiving K.ALBITOR, tell your doctor if you:
- have ever had an allergic reaction to KALBITOR. See “Who should not take 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
non-prescription 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
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?
KALBITOR can cause serious allergic reactions. See “What is the most important
information I should know about 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. You may report side effects to FDA at 1-800-FDA-1088.
General information about KALBITOR
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 KALBITOR?
Active Ingredient: ecallantide
Inactive ingredients: disodium hydrogen orthophosphate (dihydrate), monopotassium phosphate, potassium chloride, sodium chloride in water for injection.
-
Manufactured for: – Dyax Corp.
300 Technology Square, Cambridge, MA 02139 -
Issued Month Year
This Medication Guide has been approved by the U.S. Food and Drug Administration.
U.S. License No. 1789
©2009 Dyax Corp.
References
Read User Manual Online (PDF format)
Read User Manual Online (PDF format) >>