Ecallantide (Subcutaneous Route)

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.

This product is available in the following dosage forms:

• Solution

Before Using

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.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of ecallantide injection in children younger than 16 years of age. Safety and efficacy have not been established.

Geriatric

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 .

Pregnancy

Breastfeeding

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.

Drug Interactions

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

A nurse or other trained health professional will give you this medicine in a hospital or emergency clinic. This medicine is given as a shot under your skin .

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

Precautions

It is very important that your doctor check your 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 with 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

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 or troubled 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


• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• Redness of the skin


• Redness of the face, neck, arms, and occasionally, upper chest


• Runny nose


• Shortness of breath


• Skin rash


• Sneezing


• Stuffy nose


• Sweating


• Throat irritation


• Tightness in the chest


• Unusual tiredness or weakness


• Wheezing

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.