Pronunciation: BEAR-i-nert
Generic name: complement C1 esterase inhibitor
Dosage form: freeze-dried powder for reconstitution (500 IU)
Drug class: Hereditary angioedema agents

Medically reviewed by Carmen Pope, BPharm. Last updated on Mar 21, 2025.

What is Berinert?

Berinert is used to treat acute abdominal, facial, or laryngeal hereditary angioedema (HAE) attacks in adults and children. It is given by intravenous injection by a healthcare provider although appropriately trained patients may self-administer it.

Berinert is a man-made form of a protein that occurs naturally in the bloodstream and helps control swelling in the body. People with HAE do not have enough of this protein. 

Berinert gained FDA approval on October 12, 2009. There is no generic or biosimilar available.

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

Side effects

The most common Berinert side effects are:

• 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.

Serious side effects and warnings

Do not use Berinert, C1 Esterase Inhibitor (Human), if you have experienced life-threatening allergic reactions or severe hypersensitivity to the product. Inform your healthcare provider of all medications you are taking and of any medical conditions, especially any history of blood-clotting problems. Get emergency medical help if you have signs of an allergic reaction to Berinert: hives; chest tightness, fast heartbeats, feeling light-headed; wheezing or difficulty breathing, blue lips or gums; or swelling of your face, lips, tongue, or throat.

Blood clots have occurred in patients receiving Berinert. Tell your healthcare provider if you have a history of heart or blood vessel disease, stroke, or blood clots, or if you have thick blood, an indwelling catheter/access device in a vein, or have been immobile for some time. Certain medications, such as birth control pills, may also increase your risk of clotting problems. Report to your physician or an emergency room any signs and symptoms of a blood clot, such as:

• pain and/or swelling or discoloration of an arm or leg
• warmth over the affected area
• unexplained shortness of breath
• chest pain or discomfort that worsens on deep breathing
• rapid pulse
• numbness or weakness on one side of the body.

If you have been trained to self-administer Berinert, immediately prepare the prescribed dose at the first symptoms of an attack. Seek immediate medical attention and do not begin to self-administer if an HAE attack has progressed to a point where you will be unable to prepare or administer a dose of Berinert.

• If you self-administer to treat a laryngeal attack, immediately seek medical attention afterward.
• If you self-administer for an abdominal attack, inform your physician so that other possible causes can be ruled out.
• Call your doctor right away if swelling is not controlled after using Berinert.

In clinical studies, the most serious adverse reaction reported in subjects who received Berinert was an increased severity of the pain associated with HAE. In the placebo-controlled clinical trial, the most common adverse reaction reported more often among subjects who received Berinert than those receiving placebo was dysgeusia (a bad taste in mouth). Tell your healthcare provider about any side effect that bothers you or does not go away.

Because Berinert is made from human blood, the risk that it may transmit infectious agents, including viruses and theoretically, the agents of Creutzfeldt-Jakob Disease (CJD) and its variant form (vCJD), cannot be eliminated.

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

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.

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 the FDA at 1-800-FDA-1088.

Related/similar drugs

Before taking this medicine

You should not use Berinert if you have ever had a life-threatening allergic reaction to a 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 risks.

How should I use Berinert?

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. injection

• 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 the Berinert Package Insert and 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 vials 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.

Dosing information

For treatment of acute attacks of HAE in adults and children: 20 units per kg body weight IV

• Administer at a rate of approximately 4 mL per minute.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose.

What happens if I overdose?

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

What should I avoid after using Berinert?

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

What other drugs will affect Berinert?

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 inhibitors, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Storage

Berinert is stable for the period indicated by the expiration date on the carton and vial label when stored at temperatures of 2-30°C (36-86°F).

Keep Berinert in its original carton until ready to use.

Do not freeze and protect from light.

Discard any unused product and all used disposable supplies

Berinert ingredients

Each Berinert vial contains 500 IU of C1 esterase inhibitor as a lyophilized concentrate for reconstitution with 10 mL of Sterile Water for Injection, USP provided.

Who makes Berinert?

Berinert is manufactured by CSL Behring, a global biopharmaceutical company specializing in plasma-derived and recombinant therapeutic products.

CSL Behring is headquartered in King of Prussia, Pennsylvania, USA. CSL Behring is a subsidiary of CSL Limited, which has global headquarters in Melbourne, Australia.

Berinert Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Berinert.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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