Cinryze

Cinryze is a prescription medication used to prevent angioedema attacks in adults and adolescents with hereditary angioedema (HAE). Cinryze belongs to a class of medications called recombinant serine proteinase inhibitors. These work to prevent angioedema attacks by reducing the permeability of certain small blood vessels.

This medication is available in an injectable form to be given directly into a vein and is typically given every 3 or 4 days.

Common side effects of Cinryze include headache, nausea, and rash.

Cinryze can also cause dizziness. Do not drive or operate heavy machinery until you know how Cinryze affects you.

Cinryze is a prescription medication used to prevent angioedema attacks in adults and adolescents with hereditary angioedema (HAE).

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• ViroPharma Biologics

Serious side effects have been reported with Cinryze. See the “Cinryze Precautions” section.

Common side effects of Cinryze include the following:

• headache
• nausea
• rash
• fever
• dizziness
• injection site pain

This is not a complete list of Cinryze side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• alteplase
• anistreplase
• bazedoxifene
• chlorotrianisene
• conjugated estrogens
• danazol
• darbepoetin alfa
• dehydroepiandrosterone
• desogestrel
• dienestrol
• dienogest
• diethylstilbestrol
• drospirenone
• epoetin alfa
• epoetin beta-methoxy polyethylene glycol
• esterified estrogens
• estradiol
• estrone
• estropipate
• ethinyl estradiol
• fluoxymesterone
• lenalidomide
• mestranol
• methyltestosterone
• nandrolone
• ospemifene
• oxandrolone
• oxymetholone
• peginesatide
• pomalidomide
• quinestrol
• raloxifene
• reteplase
• stanozolol
• streptokinase
• tamoxifen
• tenecteplase
• testolactone
• testosterone
• thalidomide
• toremifene
• urokinase            

This is not a complete list of Cinryze drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Cinryze including the following:

• Serious allergic reactions. The signs and symptoms of serious allergic reactions may include the appearance of hives, skin redness, itching, tightness of the chest, and/or wheezing experienced during or after injection of Cinryze. If you experience any of these symptoms, discontinue use immediately and seek emergency medical attention.
• Blood clots. Serious blood clots have been reported in patients taking the recommended doses of Cinryze. Risk factors may include presence of a permanent catheter, prior history of blood clots, heart disease, use of oral contraceptives, morbid obesity, and immobility. Benefits of Cinryze should be weighed against the risks of blood clots in people with underlying risk factors. Consult with your physician about the risks for developing serious blood clots before beginning treatment with Cinryze.
• Transmission of infectious agents. Because Cinryze is made from human blood products, it may carry a risk of transmitting infectious agents including viruses like HIV. Consult with your physician about this risk before beginning treatment with Cinryze.

Cinryze can also cause dizziness. Do not drive or operate heavy machinery until you know how Cinryze affects you.

Do not take Cinryze if you are allergic to Cinryze or to any of its ingredients.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Cinryze, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Cinryze, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Cinryze or to any of its ingredients
• have a history of blood clots
• have heart disease
• use contraceptive medications
• are overweight or obese
• are immobile
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Cinryze falls into category C. There are no well-controlled studies that have been done in pregnant women. Cinryze should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Cinryze crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Cinryze.

Take Cinryze exactly as prescribed.

• Cinryze comes in an injectable form to be given directly into a vein and is typically given every 3 or 4 days.
• Do not attempt to self-administer unless you have been taught how by your healthcare provider
• Call your healthcare provider right away if swelling is not controlled after using Cinryze

You should always follow the specific instructions given by your healthcare provider. The steps listed below are general guidelines for using Cinryze. If you are unsure of the steps, please call your healthcare provider or pharmacist before using.

Preparation of Cinryze

Always wash your hands before doing the following steps. Try to keep everything clean and germ-free while you are reconstituting Cinryze. Once you open the vials, you should finish preparing Cinryze as soon as possible. This will help to keep them germ-free.

Note: Two vials of Cinryze are required for each dose. You should reconstitute both vials according to steps 1 through 6.

1. Let the vial of Cinryze and the vial of Sterile Water for Injection, USP (diluent) reach room temperature.

2. Remove the cap from the vial of Cinryze and Sterile Water for Injection, USP (diluent) vial to show the center part of the rubber stopper.

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.

4. Note: Diluent vial must be penetrated before the Cinryze vial to prevent loss of vacuum.Remove the protective covering from the top of the Mix2Vial transfer device package. Do not remove the device from the package. Place the Sterile Water for Injection, USP (diluent) vial on a flat surface, and place the blue end of the Mix2Vial transfer device over it, pushing down until the spike penetrates the rubber stopper and the device snaps in place. Mix2Vial transfer device must be positioned completely upright before penetrating the rubber stopper. Remove the plastic package and discard it. Take care not to touch the exposed end of the device.

5. Place the vial of Cinryze on a flat surface. Turn the diluent vial containing 5 mL Sterile Water for Injection, USP, upside-down and insert the clear end of the Mix2Vial transfer device into the vial of Cinryze, pushing down until the spike penetrates the rubber stopper and the device snaps in place. The Mix2Vial transfer device must be positioned completely upright before penetrating the rubber stopper. The Sterile Water for Injection, USP, will automatically flow into the vial of Cinryze because the vacuum in the vial will draw the Sterile Water for Injection, USP, into the vial of Cinryze. If this does not happen, do not use the product.

6. Once all the Sterile Water for Injection, USP, is in the Cinryze vial, gently swirl (do not shake) the vial of Cinryze until all the powder is dissolved. Disconnect the Sterile Water for Injection, USP vial by turning it counterclockwise. Do not remove the clear end of the Mix2Vial transfer device from the vial of Cinryze.

   Look at the final solution before using it to make sure that Cinryze is completely dissolved. The solution should be clear with no evidence of cloudiness. Reconstituted solution should be colorless to slightly blue. Do not use if solution is cloudy or otherwise discolored.

   One vial of dissolved Cinryze contains 5 mL of C1 esterase inhibitor at a concentration of 100 Units/mL. Prepare two vials of Cinryze for one dose. Repeat steps 1-6 using a new Mix2Vial transfer device. Do not reuse the Mix2Vial transfer device. Cinryze should be administered within 3 hours of reconstitution.

7. Utilizing a sterile, disposable 10mL syringe, draw back the plunger to allow approximately 5mL of air into the syringe. Use of a silicone-free syringe is recommended.

8. Attach the syringe onto the clear end of the Mix2Vial transfer device by turning it clockwise.

9. Turn the vial of Cinryze upside down, inject air into the vial. Slowly pull as much dissolved Cinryze as possible into the syringe. While holding the vial upside down, detach the syringe from the vial by turning it counterclockwise and releasing it from the Mix2Vial transfer device. Remove any air bubbles by gently tapping the syringe with your finger and slowly pushing the air out of the syringe.

   Repeat steps 7-9 above with a second vial of Cinryze to make one complete dose of 10 mL.

10. Dispose of the vials with the Mix2Vial transfer device attached to them.

Cinryze should be administered at room temperature promptly after preparation in the syringe.

Self-Administration

Your healthcare provider will teach you how to safely administer Cinryze. It is important that Cinryze 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 these instructions.

1. Attach a needle or infusion set with a winged adapter to the syringe containing the dissolved Cinryze solution. Fill the tubing with dissolved Cinryze by gently pushing the plunger of the syringe. Be careful not to spill the dissolved Cinryze. This process replaces the air in the tubing with dissolved Cinryze.

2. Apply a tourniquet and prepare the injection site by wiping the skin well with an alcohol swab.

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.

   • Inject the dissolved Cinryze product slowly over ten minutes (approximately 1mL/min).

4. After infusing Cinryze, remove the infusion set and discard. Cover infusion site with an adhesive bandage. 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.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Cinryze at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your age

The recommended dose of Cinryze to prevent angioedema attacks in adults and adolescents with hereditary angioedema (HAE) is 1,000 International Units (IU) injected into a vein (intravenously) every 3 or 4 days.

If you take too much Cinryze, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Cinryze is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store at 2°C–25°C (36°F-77°F)
• Do not freeze
• Store the vial in the original carton to protect it from light
• Do not use beyond the expiration date on the vial of Cinryze