Ecallantide

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

Ecallantide is not a cure for hereditary angioedema.

Ecallantide may also be used for reasons not mentioned in this medication guide.

Ecallantide is given as an injection under the skin by a healthcare provider, typically in 3 separate injections.

You will be monitored closely to ensure you do not have an allergic reaction to the medication.

If you continue to have angioedema symptoms after 3 injections, more may be given within 24 hours.

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.

If you can, during an emergency, inform your caregivers about any allergies you have. Ensure that any doctor you see afterward knows you received ecallantide.

You should not receive ecallantide if you are allergic to it.

If you can, during an emergency, let your caregivers know if you are pregnant or breastfeeding.

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.

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.

In a medical setting, it is unlikely that you will miss a dose.

In a medical setting, an overdose would be treated quickly.

Follow your doctor's instructions about any limits on food, drinks, or activities.

Other drugs may affect ecallantide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.