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Cinryze

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Cinryze

PATIENT INFORMATION

CINRYZE™ (c1 esterase inhibitor [human] freeze dried powder)
(SIN-rise)

(c1 esterase inhibitor [human])

This leaflet summarizes important information about CINRYZE (c1 esterase inhibitor [human] freeze dried powder) . Please read it carefully before using CINRYZE (c1 esterase inhibitor [human] freeze dried powder) and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider, and it does not include all of the important information about CINRYZE (c1 esterase inhibitor [human] freeze dried powder) . If you have any questions after reading this, ask your healthcare provider.

Do not attempt to self-administer unless you have been taught how by your healthcare provider.

What is CINRYZE (c1 esterase inhibitor [human] freeze dried powder) ?

CINRYZE (c1 esterase inhibitor [human] freeze dried powder) is an injectable medicine that is used to help prevent swelling and /or painful attacks in teenagers and adults with Hereditary Angioedema (HAE). HAE is caused by the decreased functioning of a protein called C1 esterase inhibitor, that is present in your blood and helps control inflammation (swelling) and parts of the immune system. CINRYZE (c1 esterase inhibitor [human] freeze dried powder) contains C1 esterase inhibitor. Before you can inject CINRYZE (c1 esterase inhibitor [human] freeze dried powder) into your vein (intravenous injection), you must dissolve the CINRYZE (c1 esterase inhibitor [human] freeze dried powder) powder using Sterile Water for Injection, USP. You can get supplies, including Sterile Water for Injection, USP from your pharmacist.

Who should not use CINRYZE (c1 esterase inhibitor [human] freeze dried powder) ?

You should not use CINRYZE (c1 esterase inhibitor [human] freeze dried powder) if you have had life-threatening immediate hypersensitivity reactions, including anaphylaxis to the product.

What should I tell my healthcare provider before using CINRYZE (c1 esterase inhibitor [human] freeze dried powder) ?

Tell your healthcare provider about all of your medical conditions, including if you

  • are pregnant or planning to become pregnant. It is not known if CINRYZE (c1 esterase inhibitor [human] freeze dried powder) can harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if CINRYZE (c1 esterase inhibitor [human] freeze dried powder) passes into your milk and if it can harm your baby.
  • have a history of blood clotting problems. Very high doses of C1 esterase inhibitor could increase the risk of blood clots.

Tell your healthcare provider and pharmacist about all of the medicines you take, including all prescription and non-prescription medicines such as over-the-counter medicines, supplements, or herbal remedies.

What are the possible side effects of CINRYZE (c1 esterase inhibitor [human] freeze dried powder) ?

Allergic reactions may occur with CINRYZE (c1 esterase inhibitor [human] freeze dried powder) . Call your healthcare provider or get emergency support services right away if you have any of the following symptoms:

  • wheezing
  • difficulty breathing
  • chest tightness
  • turning blue (look at lips and gums)
  • fast heartbeat
  • swelling of the face
  • faintness
  • rash
  • hives

In clinical studies, the most common side effects seen with CINRYZE (c1 esterase inhibitor [human] freeze dried powder) were upper respiratory tract infections, sinusitis, rash, and headache.

These are not all the possible side effects of CINRYZE (c1 esterase inhibitor [human] freeze dried powder) .

Tell your healthcare provider about any side effect that bothers you or that does not go away. You can also report side effects to the FDA at 1-800-FDA-1088.

You can ask your healthcare provider for information that is written for healthcare providers.

How should I store CINRYZE (c1 esterase inhibitor [human] freeze dried powder) ?

Do not freeze CINRYZE (c1 esterase inhibitor [human] freeze dried powder) .

Store CINRYZE (c1 esterase inhibitor [human] freeze dried powder) in a refrigerator or at room temperature between 36° to 77°F (2° to 25°C).

Keep CINRYZE (c1 esterase inhibitor [human] freeze dried powder) in the original carton to protect it from light.

Do not use CINRYZE (c1 esterase inhibitor [human] freeze dried powder) after the expiration date on the vial.

After preparing CINRYZE (c1 esterase inhibitor [human] freeze dried powder) , you can store it at room temperature for up to 3 hours. If you have not used it within 3 hours, throw it away.

Only use the dissolved CINRYZE (c1 esterase inhibitor [human] freeze dried powder) if it is colorless to slightly blue, clear and free from visible particles.

What else should I know about CINRYZE (c1 esterase inhibitor [human] freeze dried powder) ?

Medicines are sometimes prescribed for purposes other than those listed here. Do not use CINRYZE (c1 esterase inhibitor [human] freeze dried powder) for a condition for which it is not prescribed. Do not share CINRYZE (c1 esterase inhibitor [human] freeze dried powder) with other people, even if they have the same symptoms that you have.

Because CINRYZE (c1 esterase inhibitor [human] freeze dried powder) is made from human blood, it may carry a risk of transmitting infectious agents, e.g. viruses, and, theoretically, the Creutzfeldt-Jakob (CJD) agent.

This leaflet summarizes the most important information about CINRYZE (c1 esterase inhibitor [human] freeze dried powder) . If you would like more information, talk to your healthcare provider. You can ask your healthcare provider or pharmacist for information about CINRYZE (c1 esterase inhibitor [human] freeze dried powder) that was written for healthcare professionals.

Instructions for Use

Do not attempt to self-administer unless you have been taught how by your healthcare provider.

See the step-by-step instructions for injecting CINRYZE (c1 esterase inhibitor [human] freeze dried powder) at the end of this leaflet. You should always follow the specific instructions given by your healthcare provider. The steps listed below are general guidelines for using CINRYZE (c1 esterase inhibitor [human] freeze dried powder) . If you are unsure of the steps, please call your healthcare provider or pharmacist before using.

Call your healthcare provider right away if swelling is not controlled after using CINRYZE (c1 esterase inhibitor [human] freeze dried powder) .

Your healthcare provider will prescribe the dose that you should take.

Call your healthcare provider if you take too much CINRYZE (c1 esterase inhibitor [human] freeze dried powder) .

Call your healthcare provider if you miss a dose of CINRYZE (c1 esterase inhibitor [human] freeze dried powder) .

Talk to your healthcare provider before traveling. You should plan to bring enough CINRYZE (c1 esterase inhibitor [human] freeze dried powder) for your treatment during this time.

Preparation of CINRYZE (c1 esterase inhibitor [human] freeze dried powder)

Always wash your hands before doing the following steps. Try to keep everything clean and germ-free while you are reconstituting CINRYZE (c1 esterase inhibitor [human] freeze dried powder) . Once you open the vials, you should finish preparing CINRYZE (c1 esterase inhibitor [human] freeze dried powder) as soon as possible. This will help to keep them germ-free.

Note: Two vials of CINRYZE (c1 esterase inhibitor [human] freeze dried powder) are required for each dose. You should reconstitute both vials according to steps 1 through 10.

  1. Let the vial of CINRYZE (c1 esterase inhibitor [human] freeze dried powder) and the vial of Sterile Water for Injection, USP reach room temperature.
  2. Remove the cap from the CINRYZE (c1 esterase inhibitor [human] freeze dried powder) vial and Sterile Water for Injection, USP vial to show the center part of the rubber stopper.

Preparation of CINRYZE - Illustration

3. Wipe the top of each vial with an alcohol wipe or swab, and allow it to dry. Do not blow on the stopper to dry it faster. Place each vial on a flat surface. After cleaning, do not touch the rubber stopper with your hand or allow it to touch any surface.

Wipe the top of each vial - Illustration 1

Wipe the top of each vial - Illustration 2

4. Remove the protective covering from the shorter end of the double-ended transfer needle, place the vial on a flat surface, and insert the exposed needle through the center of the vial of Sterile Water for Injection, USP. While holding the needle in the vial, remove the protective covering from the longer end of the double-ended transfer needle.

Remove the protective covering - Illustration

5. Turn the vial containing Sterile Water for Injection, USP, upside-down and quickly insert the free end of the needle through the center of the stopper of a CINRYZE (c1 esterase inhibitor [human] freeze dried powder) vial. Hold the Sterile Water for Injection, USP vial at a slight angle, allowing the diluent to flow down the side of the CINRYZE (c1 esterase inhibitor [human] freeze dried powder) vial to prevent foaming. The vacuum in the vial will draw the Sterile Water for Injection, USP, into the CINRYZE (c1 esterase inhibitor [human] freeze dried powder) vial. If this does not happen, do not use the product.

Quickly insert the free end of the needle through the center of the stopper - Illustration

6. Once all the Sterile Water for Injection, USP, is in the CINRYZE (c1 esterase inhibitor [human] freeze dried powder) vial, disconnect the two vials by removing the needle from the CINRYZE (c1 esterase inhibitor [human] freeze dried powder) vial stopper. Discard the vial that contained the Sterile Water for Injection, USP along with the transfer needle directly into a sharps container. Gently swirl the CINRYZE (c1 esterase inhibitor [human] freeze dried powder) container until all the powder is dissolved. Do not shake.

Discard the vial - Illustration

Look at the final solution before using it to make sure that CINRYZE (c1 esterase inhibitor [human] freeze dried powder) is completely dissolved. Once dissolved, the solution in the CINRYZE (c1 esterase inhibitor [human] freeze dried powder) vial should be colorless to slightly blue and clear. Do not use the product if the solution is cloudy, discolored or contains any particles. Throw it away and prepare a new vial of CINRYZE (c1 esterase inhibitor [human] freeze dried powder) .

One vial of dissolved CINRYZE (c1 esterase inhibitor [human] freeze dried powder) contains 5 mL of C1 esterase inhibitor at a concentration of 100 Units/mL. Prepare two vials of CINRYZE (c1 esterase inhibitor [human] freeze dried powder) for one dose.

7. Attach the filter needle to a sterile, disposable 10mL syringe and draw back the plunger to allow approximately 5mL of air into the syringe.

Attach the filter needle to a sterile, disposable 10mL syringe - Illustration

8. Insert the filter needle into the vial of dissolved CINRYZE (c1 esterase inhibitor [human] freeze dried powder) on a flat surface.

Insert the filter needle into the vial - Illustration

9. Turn the vial of CINRYZE (c1 esterase inhibitor [human] freeze dried powder) upside down, inject air into the vial (not into the solution), and then slowly pull as much CINRYZE (c1 esterase inhibitor [human] freeze dried powder) solution as possible into the syringe. Withdraw the needle and syringe from the vial and remove any air bubbles by gently tapping the syringe with your finger and slowly pushing the air out of the syringe.

Turn the vial, withdraw the syringe and remove air bubbles - Illustration

10. Remove and throw away the filter needle in a hard-walled sharps container for proper disposal.

Filter needles are meant to filter the contents of a single dose (2 vials) of CINRYZE (c1 esterase inhibitor [human] freeze dried powder) only.

Repeat steps 1-10 above with a second vial of CINRYZE (c1 esterase inhibitor [human] freeze dried powder) to make one complete dose of 10mL.

CINRYZE (c1 esterase inhibitor [human] freeze dried powder) should be administered within 3 hours after preparation. The dissolved CINRYZE (c1 esterase inhibitor [human] freeze dried powder) solution may be stored at room temperature prior to administration. If not used within 3 hours after preparation, throw away the CINRYZE (c1 esterase inhibitor [human] freeze dried powder) solution.

SELF ADMINISTRATION (Intravenous Injection)

Your healthcare provider will teach you how to safely administer CINRYZE (c1 esterase inhibitor [human] freeze dried powder) . It is important that CINRYZE (c1 esterase inhibitor [human] freeze dried powder) is injected directly into a superficial vein and not injected into surrounding tissues and not injected into an artery. Once you learn how to self-administer, you can follow the instructions in this insert.

  1. Attach a needle or infusion set with a winged adapter to the syringe containing the dissolved CINRYZE (c1 esterase inhibitor [human] freeze dried powder) solution.
  2. Apply a tourniquet and prepare the injection site by wiping the skin well with an alcohol swab.

Apply a tourniquet and prepare the injection site - Illustration

3. As instructed by your healthcare provider:

  • Insert the butterfly needle of the infusion set tubing into your vein.
  • Remove the tourniquet.
  • Make sure that the needle is in a vein and that all the air has been removed from the tubing.
  • Inject the dissolved CINRYZE (c1 esterase inhibitor [human] freeze dried powder) product slowly over ten minutes (approximately 1mL/min).

Inject the dissolved CINRYZE product slowly - Illustration

4. After infusing CINRYZE (c1 esterase inhibitor [human] freeze dried powder) , remove the infusion set and discard. The amount of drug product left in the infusion set will not affect your treatment. Dispose of all unused solution, the empty vials, and the used needles and syringe in an appropriate container used for throwing away waste that might hurt others if not handled properly.

Remove the infusion set and discard - Illustration

It is a good idea to record the lot number from the CINRYZE (c1 esterase inhibitor [human] freeze dried powder) vial label every time you use CINRYZE (c1 esterase inhibitor [human] freeze dried powder) .

This Patient Package Insert has been approved by the U.S. Food and Drug Administration.

Last reviewed on RxList: 10/2/2009
This monograph has been modified to include the generic and brand name in many instances.

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