July 27, 2016
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Berinert Patient Information including How Should I Take

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

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

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 (Berinert)?

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.

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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