Berinert

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

What is complement C1 esterase inhibitor?

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.

Complement C1 esterase inhibitor is used to prevent attacks of angioedema in people with hereditary angioedema.

Complement C1 esterase inhibitor may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about complement C1 esterase inhibitor?You should not use this medication if you have ever had an allergic reaction to it, or if you have ever had any life-threatening allergic reaction.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before using complement C1 esterase inhibitor, tell your doctor if you have a history of stroke or blood clot.

Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of needles, IV tubing, and other items used in giving the medicine. This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

If you are using the injections at home, be sure you understand how to properly mix and store the medication. Do not mix the medicine until you are ready to give the injection.

Stop your IV 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.

Complement C1 esterase inhibitor is made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

What should I discuss with my health care provider before using complement C1 esterase inhibitor?You should not use this medication if you have ever had an allergic reaction to it, or if you have ever had any other life-threatening allergic reaction.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before using complement C1 esterase inhibitor, tell your doctor if you have a history of stroke or blood clot.

FDA pregnancy category C. It is not known whether this medication is harmful to an unborn baby. Before using complement C1 esterase inhibitor, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether complement C1 esterase inhibitor passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Complement C1 esterase inhibitor is made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, 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 this medication to a child, even if you think the child has the same condition you have.

How should I use complement C1 esterase inhibitor?

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

Complement C1 esterase inhibitor is given as an injection through a needle placed into a vein. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to use your medicine at home.

Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of needles, IV tubing, and other items used in giving the medicine. This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Complement C1 esterase inhibitor is usually given every 3 or 4 days for routine prevention of angioedema attack. An IV infusion takes about 10 minutes to complete.

Complement C1 esterase inhibitor is a dry powder that must be mixed with a liquid (diluent) before using it. If you do not receive the diluent with your medication at the pharmacy, talk to your pharmacist.

If you are using the injections at home, be sure you understand how to properly mix and store the medication. Do not mix the medicine until you are ready to give the injection.

Complement C1 esterase inhibitor 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 the vial after one use, even if there is still some medicine left in it after injecting your dose.

After mixing complement C1 esterase inhibitor with the diluent, use it right away or store the mixture at room temperature and use it within 3 hours. The mixed medicine should be clear or slightly blue in color. Do not use the mixed medication if it has changed colors, is cloudy, or has any particles in it.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). 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.

What happens if I miss a dose?

Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

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

What should I avoid while using complement C1 esterase inhibitor?

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using complement C1 esterase inhibitor.

Complement C1 esterase inhibitor side effects

Stop your IV 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. Call your doctor at once if you have any other serious side effect, such as:

• 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 or swelling in one or both legs.

Less serious side effects may include:

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

• mild itching or rash;

• mild headache; or

• back pain.

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.

What other drugs will affect complement C1 esterase inhibitor?

There may be other drugs that can interact with complement C1 esterase inhibitor. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. 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 complement C1 esterase inhibitor.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• 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 1996-2006 Cerner Multum, Inc. Version: 2.01. Revision Date: 11/10/2009 11:04:56 AM.