Berinert

Generic Name: complement C1 esterase inhibitor (KOM ple ment C1 ES ter ase in HIB it or)
Brand Names: Berinert, Cinryze

What is Berinert?

Berinert (complement C1 esterase inhibitor) is a man-made form of a protein that occurs naturally in the bloodstream and helps control inflammation in the body. In people with hereditary angioedema, complement C1 esterase inhibitor does not function properly or occurs in low levels.

Berinert is an injectable medicine used to treat acute abdominal or facial attacks in adults and adolescents with hereditary angioedema (HAE).

Berinert may also be used for purposes not listed in this medication guide.

Important information about Berinert

You should not use Berinert if you are allergic to complement C1 esterase inhibitor, or if you have ever had any life-threatening allergic reaction.

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

Do not give Berinert to a child without medical advice.

Do not self-inject this medicine. A healthcare provider will give you a Berinert injection in a clinic or hospital setting. The IV infusion must be stopped 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 Berinert.

Before using Berinert

You should not use Berinert if you are allergic to complement C1 esterase inhibitor, or if you have ever had any other life-threatening allergic reaction.

To make sure you can safely use Berinert, tell your doctor if you have a history of stroke or blood clot.

FDA pregnancy category C. It is not known whether Berinert will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether complement C1 esterase inhibitor passes into breast milk or if it could harm a nursing baby. Do not use Berinert without telling your doctor if you are breast-feeding a baby. 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 medication. Do not give Berinert to a child without medical advice.

See also: Berinert pregnancy and breastfeeding warnings (in more detail)

How should I use Berinert?

Berinert is injected into a vein through an IV. A healthcare provider will give you a Berinert injection in a clinic or hospital setting.

Berinert is a powder medicine that must be mixed with a liquid (diluent) before using it. Berinert contains no preservative. Any product that has been mixed should be used promptly. The mixed solution must be used within 8 hours.

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 the dose.

Store the unmixed dry powder between 2-25 ° C. Keep the medicine protected from light and do not allow it to freeze. Throw away any unused vials after the expiration date on the label has passed.

What happens if I miss a dose?

As this medicine is given in a clinic or hospital setting, it is not likely that you will miss a dose.

What happens if I overdose?

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

Overdose symptoms may include sudden headache, numbness, weakness, or problems with your speech, vision, or balance.

What should I avoid while using Berinert?

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using Berinert.

Berinert side effects

Stop the IV infusion and get emergency medical help if you have any of these signs of an allergic reaction to Berinert: hives; wheezing or difficult breathing; feeling like you might pass out; or swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any other serious side effect, such as:

• new or worsening pain;

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

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

• stomach pain or swelling;

• chest pain, sudden cough, rapid breathing, fast heart rate; or

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

Less serious Berinert side effects may include:

• nausea, vomiting, diarrhea, stomach pain;

• cold symptoms such as stuffy nose, sneezing, sore throat;

• mild itching or rash; or

• mild headache.

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.

See also: Berinert side effects (in more detail)

What other drugs will affect Berinert?

There may be other drugs that can interact with Berinert. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your doctor or pharmacist can provide more information about Berinert.