Pronunciation:

e-KAL-lan-tide

Brand Names:

• Kalbitor

Dosage Forms:

• Solution

Warnings:

Anaphylaxis has been reported after administration of ecallantide. Because of this risk, ecallantide should only be administered by a healthcare professional who is aware of the similarity of symptoms between anaphylaxis and hereditary angioedema and who has the appropriate medical support to manage both conditions. Patients should be monitored closely .

Classifications:

Therapeutic—

Immune Modulator

Uses of This Medicine:

Ecallantide injection is used to treat sudden attacks of hereditary angioedema (HAE). Ecallantide works by blocking a chemical in the body that causes swelling, inflammation, and pain for patients with HAE. This medicine is not a cure for HAE.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of ecallantide injection in children younger than 12 years of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ecallantide injection in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution in patients receiving ecallantide injection.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of This Medicine:

A nurse or other trained health professional will give you or your child this medicine in a hospital or emergency clinic. This medicine is given as a shot under your skin (usually in the abdomen, thigh, or upper arm).

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress closely to make sure that this medicine is working properly and to decide if you should continue to receive it.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor or nurse right away if you have a cough, difficulty with swallowing, dizziness, a fast heartbeat, wheezing, shortness of breath, trouble breathing, chest tightness, swelling in your face, hands, tongue, or throat, a fever, chills, a runny nose or sneezing, itching or hives, or lightheadedness or faintness after you get the injection.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Less common

Blurred vision

chest discomfort

confusion

cough

difficulty with breathing

difficulty with swallowing

dizziness

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

fast heartbeat

feeling of warmth

fever

hives or welts, itching, or skin rash

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

redness of the face, neck, arms, and occasionally, upper chest

redness of the skin

runny nose

sneezing

stuffy nose

sweating

throat irritation

tightness in the chest

unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Headache

Less common

Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

muscle aches

nausea

sore throat

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.