Haegarda is a man-made form of a protein in blood that helps control swelling in the body. People with a condition called Hereditary Angioedema (HAE) do not have enough of this protein. Hereditary Angioedema can cause attacks of swelling and symptoms such as stomach problems or trouble breathing.

Haegarda is an injectable medicine used to prevent swelling and/or painful attacks in patients 6 years of age and older with Hereditary Angioedema.

Haegarda should not be used to treat an acute HAE attack. In case of an acute HAE attack, initiate individualized treatment as discussed with your health care professional.

You should not use Haegarda if you have experienced life-threatening immediate hypersensitivity reactions (allergic reactions), including anaphylaxis, to the product.

Before taking this medicine

You should not use Haegarda if have ever had a life-threatening allergic reaction to c1 esterase inhibitor.

To make sure Haegarda is safe for you, tell your doctor if you have:

• a stroke or blood clot;

• heart problems; or

• an "in-dwelling" catheter.

Tell your doctor if you are pregnant or breast-feeding.

Haegarda is made from donated human plasma and may contain viruses or other infectious agents. Donated plasma is tested and treated to reduce the risk of contamination, but there is still a small possibility it could transmit disease. Ask your doctor about any possible risk.

Use Haegarda exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Haegarda is injected under the skin. A healthcare provider will give your first dose and may teach you how to properly use the medication by yourself.

Read and carefully follow any Instructions for Use provided with your medicine. Prepare an injection only when you are ready to give it. Ask your doctor or pharmacist if you don't understand all instructions.

Storing unopened vials: Store in a refrigerator or at cool room temperature and use until expiration date. Protect from light and do not freeze.

Each vial (bottle) is for one use only. Throw it away after one use, even if there is still medicine left inside.

After mixing Haegarda, use the injection right away or store at room temperature and use within 8 hours.

Haegarda contains no preservative. Once you have pierced the rubber top of a vial with a needle, you must use that vial right away or throw it away.

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

Usual Adult Dose for Hereditary Angioedema:

Haegarda is intended for self-administration after reconstitution at a dose of 60 International Units (IU) per kg body weight by subcutaneous (S.C.) injection twice weekly (every 3 or 4 days). The patient or caregiver should be trained on how to administer the subcutaneous injection.

Use: routine prophylaxis to prevent Hereditary Angioedema (HAE) attacks 

Usual Pediatric Dose for Hereditary Angioedema:

Haegarda is intended for self-administration after reconstitution at a dose of 60 International Units (IU) per kg body weight by subcutaneous (S.C.) injection twice weekly (every 3 or 4 days). The patient or caregiver should be trained on how to administer the subcutaneous injection.

Use: routine prophylaxis to prevent Hereditary Angioedema (HAE) attacks in patients 6 years of age and older

You should not use Haegarda if have ever had a life-threatening allergic reaction to c1 esterase inhibitor.

To make sure Haegarda is safe for you, tell your doctor if you have:

• a stroke or blood clot;

• heart problems; or

• an "in-dwelling" catheter.

Tell your doctor if you are pregnant or breast-feeding.

Haegarda is made from donated human plasma and may contain viruses or other infectious agents. Donated plasma is tested and treated to reduce the risk of contamination, but there is still a small possibility it could transmit disease. Ask your doctor about any possible risk.

Call your doctor for instructions if you miss a dose of Haegarda.

Keep Haegarda on hand at all times to prevent angioedema, especially while traveling.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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

Get emergency medical help if you have signs of an allergic reaction to Haegarda: hives; chest tightness, fast heartbeats, feeling light-headed; wheezing or difficult breathing, blue lips or gums; or swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• sudden numbness or weakness on one side of the body;

• pain, swelling, warmth, or redness in an arm or leg;

• sudden severe headache, confusion, problems with vision, speech, or balance;

• chest pain while taking deep breaths; or

• fast heart rate.

Common Haegarda side effects may include:

• unusual or unpleasant taste in your mouth;

• headache, dizziness;

• nausea, vomiting;

• pain, bruising, itching, swelling, bleeding, warmth, or a hard lump where the medicine was injected;

• stuffy nose, sore throat;

• rash; or

• fever.

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.

Tell your doctor about all your other medicines, especially:

• testosterone; or

• birth control pills.

This list is not complete. Other drugs interact with c1 esterase inhibitor, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.