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

Ecallantide is not a cure for hereditary angioedema.

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

Ecallantide can cause a serious allergic reaction within 1 hour after injection. Symptoms include wheezing, cough, trouble breathing or swallowing, itching, hives, dizziness, fainting, or swelling in your face or throat.

Ecallantide is injected under the skin by a healthcare provider, usually in 3 separate injections.

You will be watched closely to make sure you do not have an allergic reaction to the medication.

If you still have angioedema symptoms after 3 injections, more 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.

If possible during an emergency, tell your caregivers you have any type of allergy. Make sure any follow-up doctor knows you received ecallantide.

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

If possible during an emergency, tell your caregivers if you are pregnant or breastfeeding.

In a medical setting you are not likely to miss a dose.

In a medical setting an overdose would be treated quickly.

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

Ecallantide can cause a serious allergic reaction within 1 hour after injection. Tell your caregivers right away if you have:

• 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 may have the same symptoms as hereditary angioedema. Your caregivers will watch you closely and will quickly treat an allergic reaction.

Common side effects of ecallantide 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.