Ruconest is a manmade form of the c1 esterase inhibitor protein that occurs naturally in the bloodstream and helps control swelling in the body. People with a condition called Hereditary Angioedema do not have enough of this protein. Hereditary Angioedema can cause attacks of swelling and symptoms such as stomach problems or trouble breathing.

Ruconest is an injectable medicine used to treat acute angioedema attacks in in adult and adolescent patients with Hereditary Angioedema.

Ruconest is for use in adults and children who are at least 13 years old.

You should not use Ruconest if you are allergic to rabbits or rabbit products (meat, fur, pelt).

You should not use Ruconest if you have experienced life-threatening immediate hypersensitivity reactions, including anaphylaxis, to this medicine or to any other C1 esterase inhibitor product.

Before taking this medicine

You should not use Ruconest if you are allergic to c1 esterase inhibitor, or:

• if you are allergic to rabbits or rabbit products (meat, fur, pelt); or

• if you have ever had a life-threatening allergic reaction to Ruconest or to another C1 esterase inhibitor (such as Berinert or Cinryze).

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

• coronary artery disease (hardened arteries); or

• a history of stroke or blood clot.

This medicine is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether c1 esterase inhibitor passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Ruconest is not approved for use by anyone younger than 13 years old.

Use Ruconest exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Ruconest is injected into a vein through an IV. You may be shown how to use an IV at home. Do not self-inject this medicine if you do not understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.

Ruconest is a powder medicine that must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medicine. Ask your pharmacist what type of diluent can safely be mixed with this medicine powder.

Wash your hands before mixing the medicine or preparing your injection.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

After mixing Ruconest, store in the refrigerator and use within 8 hours. Do not freeze.

Mixed medicine should be used right away if you keep it at room temperature.

c1 esterase inhibitor doses are based on weight. You may need to use two vials of Ruconest powder to make up a single dose. Carefully follow all mixing instructions provided with your medicine.

Each single-use vial (bottle) of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

This medicine must be injected slowly, and the IV infusion should take about 5 minutes to complete.

A single dose of Ruconest is usually enough to treat an angioedema attack. You may need to use a second dose if your symptoms do not get better after just one dose.

Store the unmixed dry powder in a refrigerator or in a dark cool place. Keep the medicine protected from light and do not allow it to freeze. Throw away any unused vial after the expiration date on the label has passed.

You should not use Ruconest if you are allergic to c1 esterase inhibitor, or:

• if you are allergic to rabbits or rabbit products (meat, fur, pelt); or

• if you have ever had a life-threatening allergic reaction to Ruconest or to another C1 esterase inhibitor (such as Berinert or Cinryze).

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

• coronary artery disease (hardened arteries); or

• a history of stroke or blood clot.

This medicine is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether c1 esterase inhibitor passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Ruconest is not approved for use by anyone younger than 13 years old.

Since Ruconest is used when needed, it does not have a daily dosing schedule. Call your doctor promptly if your symptoms do not improve after using this medicine.

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 Ruconest: rash or hives; chest tightness, wheezing, difficult breathing; blue-colored lips or gums; fast heartbeats; feeling like you might pass out; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

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

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

• pain, swelling, warmth, or redness in one or both legs.

Common Ruconest side effects may include:

• headache;

• diarrhea; or

• nausea.

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.

Other drugs may interact with c1 esterase inhibitor, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.