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Berinert

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

What is Berinert?

Berinert (complement C1 esterase inhibitor) is a man-made form of a protein that occurs naturally in the blood stream 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. Hereditary angioedema can cause attacks of swelling and symptoms such as stomach problems or trouble breathing.

Complement C1 esterase inhibitor is used in people with hereditary angioedema. Berinert is used to treat attacks of angioedema. The Cinryze brand of complement C1 esterase inhibitor is used to prevent attacks of angioedema.

Important information

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

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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.

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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.

Before using this medicine?

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

If possible before you receive Berinert, tell your doctor if you have:

  • a history of stroke or blood clot; or

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

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 medicine.

It is not known whether complement 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.

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.

How should I use Berinert?

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

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

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.

Gently swirl but do not shake the mixed medicine or you may ruin it. The dose should be prepared only when you are ready to to receive than injection.

Mixed Berinert should be clear and colorless. Do not use the mixed medicine if it has changed colors, is cloudy, or has any particles in it. Call your doctor for a new prescription.

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.

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.

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.

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

What happens if I miss a dose?

Since Berinert 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.

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 after using Berinert?

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

Berinert side effects

Stop your 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 severe 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.

Common Berinert side effects may include:

  • nausea, diarrhea;

  • altered sense of taste;

  • rash; or

  • 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: Side effects (in more detail)

What other drugs will affect Berinert?

Other drugs may interact with complement 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.

Where can I get more information?

  • Your doctor or pharmacist can provide more information about Berinert.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Berinert only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2015 Cerner Multum, Inc. Version: 4.05. Revision Date: 2015-05-04, 4:50:01 PM.

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