Thursday, September 22, 2016

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 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.


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


Complement C1 esterase inhibitor may also be used for 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 have ever had a life-threatening allergic reaction to complement C1 esterase inhibitor.

Before you receive complement C1 esterase inhibitor, tell your doctor if you have a history of stroke or blood clot.


Do not give this medication to a child without medical advice.

You may be shown how to use Cinryze in an IV at home. This medication comes with patient instructions for safe and effective use. Follow all directions carefully. Ask your doctor or pharmacist if you have any questions.


Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine. Be sure you understand how to properly mix and store the medication. 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) 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.

What should I discuss with my health care provider before using complement C1 esterase inhibitor?


You should not use this medication if have ever had a life-threatening allergic reaction to rugae.

To make sure you can safely use 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 complement C1 esterase inhibitor 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 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) 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 this medication to a child without medical advice.

How should I use complement C1 esterase inhibitor?


Use 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.


Complement C1 esterase inhibitor is injected into a vein through an IV. A healthcare provider will give you a Berinert injection in a clinic or hospital setting. You may be shown how to use Cinryze in an IV at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.


This medication comes with patient instructions for safe and effective use. Ask your doctor or pharmacist if you have any questions.


Complement C1 esterase inhibitor is a powder medicine that must be mixed with a liquid (diluent) before using it. If you are using Cinryze home, you will need to use two vials of Cinryze to make up a single dose. 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.

Mixed Berinert should be clear and colorless. Mixed Cinryze should be clear or slightly blue in color. 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.


Cinryze is usually given every 3 or 4 days to prevent angioedema attacks. An IV infusion takes about 10 minutes to complete.


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 after one use, even if there is still some medicine left in it after injecting your dose.


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. After mixing Berinert with the diluent, use it right away or store the mixture at room temperature and use it within 8 hours. After mixing Cinryze with the diluent, use it right away or store the mixture at room temperature and use it within 3 hours.

What happens if I miss a dose?


Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed 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 complement C1 esterase inhibitor?


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


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:

  • 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.



Less serious side effects may include:



  • nausea, vomiting, stomach pain;




  • altered sense of taste;




  • 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.


What other drugs will affect complement C1 esterase inhibitor?


There may be other drugs that can interact with this medication. 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.



More Berinert resources


  • Berinert Side Effects (in more detail)
  • Berinert Use in Pregnancy & Breastfeeding
  • Berinert Support Group
  • 0 Reviews for Berinert - Add your own review/rating


  • Berinert Advanced Consumer (Micromedex) - Includes Dosage Information

  • Berinert Consumer Overview

  • Berinert MedFacts Consumer Leaflet (Wolters Kluwer)

  • Berinert Prescribing Information (FDA)

  • Cinryze Prescribing Information (FDA)

  • Cinryze MedFacts Consumer Leaflet (Wolters Kluwer)

  • Cinryze Consumer Overview

  • Cinryze Monograph (AHFS DI)



Compare Berinert with other medications


  • Hereditary Angioedema


Where can I get more information?


  • Your doctor or pharmacist can provide more information about complement C1 esterase inhibitor.

See also: Berinert side effects (in more detail)


No comments:

Post a Comment