Berinert is a man-made form of a protein that occurs naturally in the blood stream 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.

Berinert is used in people with hereditary angioedema.

Berinert is used to treat attacks of angioedema. The Cinryze and Haegarda brands are used to prevent attacks of angioedema.

You should not use Berinert if have ever had a life-threatening allergic reaction to complement C1 esterase inhibitor.

Before you receive Berinert, tell your doctor if you have a history of stroke or blood clot.

Stop the Berinert infusion and get emergency medical help if you have any of these signs of an allergic reaction: hives; wheezing or difficult breathing; feeling like you might pass out; or swelling of your face, lips, tongue, or throat.

Other serious side effects may include sudden numbness or weakness, chest pain, confusion, pain or swelling, and problems with vision, speech, or balance.

Berinert is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medicine.

Use Berinert 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.

Berinert is injected into a vein through an IV.

You may be shown how to use injections at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of needles, IV tubing, and other items used.

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

Berinert is a powder medicine that must be mixed with a liquid (diluent) before using it. Follow all directions carefully. Be sure you understand how to properly mix and store the medicine.

Gently swirl but do not shake the mixed medicine or you may ruin it. Prepare your dose only when you are ready to give yourself an injection.

The powder and diluent mixture should be clear and colorless. Do not use the mixed medicine if it has changed colors or has particles in it. Call your pharmacist for new medicine.

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

Berinert 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.

Store the unmixed dry powder in a refrigerator or at cool room temperature. Protect from light and do not freeze. Throw away any unused vial after the expiration date on the label has passed.

After mixing Berinert with the diluent, use the injection right away, or store the mixture at room temperature and use it within 8 hours.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Usual Adult Dose for Hereditary Angioedema:

For treatment of acute abdominal, facial or laryngeal attacks of HAE:
Berinert: 20 units per kg body weight intravenously at a rate of approximately 4 mL per minute (500 units/10 mL).

Usual Pediatric Dose for Hereditary Angioedema:

For treatment of acute abdominal, facial or laryngeal attacks of HAE:
13 years and older:
Berinert: 20 units per kg body weight intravenously at a rate of approximately 4 mL per minute (500 units/10 mL)

You should not use Berinert if have ever had a life-threatening allergic reaction to complement C1 esterase inhibitor.

Tell your doctor if you have ever had:

• a stroke or blood clot;

• heart problems; or

• an "in-dwelling" catheter.

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

Berinert 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.

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 Berinert: 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 Berinert 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 may interact with complement C1 esterase inhibitor, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.