Kalbitor is used to treat attacks of hereditary angioedema (an immune system disorder). This medicine is for use in adults and children at least 12 years old.

Kalbitor is not a cure for hereditary angioedema.

Kalbitor may also be used for other purposes not listed in this medication guide.

You should not be treated with Kalbitor if you are allergic to ecallantide. Ecallantide can cause a serious allergic reaction within 1 hour after receiving an injection. Symptoms include wheezing, cough, trouble breathing or swallowing, itching, hives, dizziness, fainting, or swelling in your face or throat Tell your doctor if you have a history of any type of allergy.

In an emergency situation it may not be possible to tell your caregivers about your health conditions. Make sure any doctor caring for you afterward knows you have received this medicine.

Kalbitor is injected under the skin. A healthcare provider will give you this injection.

You will be watched closely after receiving your injection, to make sure you do not have an allergic reaction to the medication.

Kalbitor is usually given in 3 separate injections. If you still have symptoms of the angioedema attack, more injections may be given within 24 hours.

Usual Adult Dose for Hereditary Angioedema:

30 mg subcutaneously in three 10 mg injections; may repeat an additional 30 mg within 24 hours if attack persists.

Usual Pediatric Dose for Hereditary Angioedema:

12 years and older: 30 mg subcutaneously in three 10 mg injections; may repeat an additional 30 mg within 24 hours if attack persists.

You should not be treated with Kalbitor if you are allergic to ecallantide.

If possible before you receive Kalbitor, tell your doctor if you have a history of any type of allergy.

It is not known whether Kalbitor will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether ecallantide passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

In an emergency situation it may not be possible to tell your caregivers if you are pregnant or breast-feeding. Make sure any doctor caring for your pregnancy or your baby knows you have received this medicine.

Because you will receive Kalbitor in a medical setting, you are not likely to miss a dose.

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur and would be treated quickly.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Tell your caregivers right away if you have any of these signs of an allergic reaction to Kalbitor within 1 hour after receiving your injection:

• chest pain or tightness, fast or weak heartbeat;

• wheezing, cough, throat irritation, trouble breathing;

• hoarse voice, tight feeling in your throat, trouble swallowing;

• swelling of your lips, tongue, or throat;

• swelling or redness in your face;

• itching, rash, or hives;

• flushing (warmth, redness, or tingly feeling);

• sneezing, runny or stuffy nose; or

• dizziness, feeling like you might pass out.

An allergic reaction to ecallantide can cause symptoms that are similar to the signs of hereditary angioedema. Your caregivers will watch you closely and will quickly treat an allergic reaction to ecallantide.

Common Kalbitor side effects may include:

• headache;

• nausea, diarrhea;

• fever;

• stuffy nose, sore throat; or

• skin reactions where the medicine was injected (redness, rash, itching, bruising, swelling).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.