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would want [0.0001:<0.0001), and decreases in the average severity of attacks (p=0.0006) and the average duration of attacks (p=0.0023), as shown in table 7 . Table 7 LEVP2005-1/B Clinical Trial Secondary Efficacy Outcomes Cinryze N=22 Placebo N=22 Treatment Effect p-value Mean Severity of HAE Attacks (Score from 1 to 3) (SD) 1.3 (0.85) 1.9 (0.36) 0.0006 Mean Duration of HAE Attacks (Days) (SD) 2.1 (1.13) 3.4 (1.4) 0.0023 Days of Swelling (SD) 10.1 (10.73) 29.6 (16.9)> <0.0001 REFERENCES Davis AE, The pathophysiology of hereditary angioedema. Clin Immunol. 2005; 114:3-9. Arzneimittelkommission der Deutschen Aertzteschaft. Schwerwiegende Thrombenbildung nach Berinert HS. Dtsch Aerztebl. 2000; 97:B-864 Horstick, G et al, 2001. Circulation 104:3125-3131 How Supplied/Storage and Handling Cinryze is available in single-use vials that contain 500 Units per vial. Cinryze is supplied as a single glass vial of Cinryze powder to be reconstituted with 5 mL Sterile Water for Injection, USP (Not supplied). Cinryze, packaged for sale, is stable for 18 months when stored at 2 C 25 C (36 F-77 F). Do not freeze. Store the vial in the original carton to protect it from light. The reconstituted solution must be used within 3 hours of reconstitution. Do not use beyond the expiration date on the Cinryze vial. Patient Counseling Information Allergic-type Hypersensitivity Reactions Allergic-type hypersensitivity reactions are possible [ 5.1 ]. Inform patients of the early signs of hypersensitivity reactions [including hives (itchy white elevated patches), tightness of the chest, wheezing, hypotension] and anaphylaxis. Advise patients to discontinue use of Cinryze and contact their physicians if these symptoms occur. Pregnancy Advise female patients to notify their physician if they become pregnant or intend to become pregnant during their routine prevention with Cinryze. Nursing Advise patients to notify their physician if they are breastfeeding or plan to breastfeed. Usage While Traveling Based on their current regimen, advise patients to bring an adequate supply of Cinryze for routine prevention when traveling. Advise patients to consult with their healthcare professional prior to travel. Transmissible Infectious Agents Advise patient that, because Cinryze is made from human blood, it may carry a risk of transmitting infectious agents, e.g. viruses, and, theoretically, the Creutzfeldt-Jakob (CJD) agent [ 5.3 , 11 ]. The risk of transmitting disease has been reduced, but not eliminated, by carefully selecting blood donors, testing donors for infections, and inactivating or removing most viruses during the manufacturing process. Inform patients of the risks and benefits of Cinryze before prescribing or administering to the patient. FDA-Approved Patient Labeling Information for the Patient Cinryze (SIN- rise ) (C1 Esterase Inhibitor [Human]) This leaflet summarizes important information about Cinryze. Please read it carefully before using Cinryze 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. 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? Cinryze 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 contains C1 esterase inhibitor. Before you can inject Cinryze into your vein (intravenous injection), you must dissolve the Cinryze 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? You should not use Cinryze if you have had life-threatening immediate hypersensitivity reactions, including anaphylaxis to the product. What should I tell my healthcare provider before using Cinryze? 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 can harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if Cinryze 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? Allergic reactions may occur with Cinryze. 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 were upper respiratory tract infection, sinusitis, rash, and headache. These are not all the possible side effects of Cinryze. 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? Do not freeze Cinryze. Store Cinryze in a refrigerator or at room temperature between 36 to 77 F (2 to 25 C). Keep Cinryze in the original carton to protect it from light. Do not use Cinryze after the expiration date on the vial. After preparing Cinryze, 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 if it is colorless to slightly blue, clear and free from visible particles. What else should I know about Cinryze? Medicines are sometimes prescribed for purposes other than those listed here. Do not use Cinryze for a condition for which it is not prescribed. Do not share Cinryze with other people, even if they have the same symptoms that you have. Because Cinryze 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. If you would like more information, talk to your healthcare provider. You can ask your healthcare provider or pharmacist for information about Cinryze 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 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. 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. Your healthcare provider will prescribe the dose that you should take. Call your healthcare provider if you take too much Cinryze. Call your healthcare provider if you miss a dose of Cinryze. Talk to your healthcare provider before traveling. You should plan to bring enough Cinryze for your treatment during this time. 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. Cinryze IS A FREEZE-DRIED POWDER THAT IS SUPPLIED IN A VACUUM-SEALED VIAL. Note: Two vials of Cinryze are required for each dose. You should reconstitute both vials according to steps 1 through 6. Let the vial of Cinryze and the vial of Sterile Water for Injection, USP (diluent) reach room temperature. Remove the cap from the Cinryze vial and Sterile Water for Injection, USP (diluent) vial to show the center part of the rubber stopper. 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. 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 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. 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 Cinryze vial, pushing down until the spike penetrates the rubber stopper and the device snaps in place. The Mix2Vial must be positioned completely upright before penetrating the rubber stopper. The Sterile Water for Injection, USP, will automatically flow into the Cinryze vial because the vacuum in the vial will draw the Sterile Water for Injection, USP, into the Cinryze vial. If this does not happen, do not use the product. Once all the Sterile Water for Injection, USP, is in the Cinryze vial, gently swirl (do not shake) the Cinryze vial 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 device from the vial of Cinryze. Look at the final solution before using it to make sure that Cinryze is completely dissolved. Once dissolved, the solution in the Cinryze 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. 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. Utilizing a sterile, disposable 10mL syringe, draw back the plunger to allow approximately 5mL of air into the syringe. Attach the syringe onto the clear end of the Mix2Vial transfer device by turning it clockwise. 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. Dispose of the vials with the Mix2Vial transfer device attached to them. Cinryze should be administered within 3 hours after preparation. The dissolved Cinryze solution may be stored at room temperature prior to administration. If not used within 3 hours after preparation, throw away the Cinryze solution. SELF ADMINISTRATION (Intravenous Injection) 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 the instructions in this insert. 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. Apply a tourniquet and prepare the injection site by wiping the skin well with an alcohol swab. 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). 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. It is a good idea to record the lot number from the Cinryze vial label every time you use Cinryze. This Patient Package Insert has been approved by the U.S. Food and Drug Administration . Manufactured by: Sanquin Blood Supply Foundation Amsterdam, The Netherlands Distributed by: ViroPharma Biologics, Inc. Exton, PA 19341 U.S. License Number 1833 Mix2Vial is a registered trademark of Medimop Medical Projects, Ltd. in the United States and other jurisdictions. Cinryze is a trademark of ViroPharma Incorporated or its subsidiaries. 2010 ViroPharma Incorporated. All rights reserved. Vial Label FOR INTRAVENOUS INJECTION 49-226 C1 esterase inhibitor (human) ClNRYZE TM 500 u NDC 42227-081-05 Reconstitute with 5 mL Sterile Water for Injection, USP. Use entire contents within 3 hours of reconstitution. Single-use vial Rx only US License No. 1833 Manufactured by Sanquin Blood Supply Foundation, Amsterdam, Netherlands 1006 AD, for ViroPharma Biologics, Inc. , Exton, PA 19341 Carton Label FOR INTRAVENOUS INJECTION C1 esterase inhibitor (human) ClNRYZE TM 500 U Contains 1 single-use vial. Recommended dose is 1000 U (2 vials). Rx only NDC 42227-081-05 See package insert for full prescribing information and administration. ViroPharma Biologics, Inc. Cinryze c1 esterase inhibitor (human) injection, powder, lyophilized, for solution Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:42227-081 Route of Administration INTRAVENOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength human c1-esterase inhibitor (human c1-esterase inhibitor) human c1-esterase inhibitor 500 [iU] in 5 mL Inactive Ingredients Ingredient Name Strength sodium chloride sucrose trisodium citrate dihydrate Valine Alanine Threonine Packaging # Item Code Package Description 1 NDC:42227-081-05 1 VIAL (1 VIAL) in 1 CARTON 1 5 mL in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA125267 12/01/2008 Labeler - ViroPharma Biologics (832763085) Establishment Name Address ID/FEI Operations Sanquin Blood Products Foundation, Plasma Products Division 387373046 MANUFACTURE Establishment Name Address ID/FEI Operations C.A.F.-D.C.F. cvba-scrl: Centrale Afdeling voor Fractionering van het Rode Kruis cvba - Departement Central de Fractionnement de la Croix-Rouge S.C.R.L 375250156 MANUFACTURE Revised: 11/2010 ViroPharma Biologics Next Interactions Print this page Add to My Med List More about Cinryze (C1 esterase inhibitor (human)) Side Effects During Pregnancy or Breastfeeding Dosage Information Drug Interactions Compare Alternatives Support Group Pricing & Coupons En Español 4 Reviews Add your own review/rating Drug class: miscellaneous coagulation modifiers Consumer resources Cinryze Cinryze (Advanced Reading) Professional resources Cinryze (AHFS Monograph) Other brands: Berinert Related treatment guides Hereditary Angioedema> 0.0001> 0.0001),>]} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Manufacturers Shire US, Inc. ViroPharma Drug Class Miscellaneous coagulation modifiers Related Drugs miscellaneous coagulation modifiers pentoxifylline , Trental , tranexamic acid , Lysteda , Amicar , BeneFix Hereditary Angioedema Firazyr , Berinert , Haegarda , Ruconest , icatibant , Kalbitor , ecallantide , C1 esterase inhibitor (human) , conestat alfa , More... Cinryze Rating 4 User Reviews 8.2 /10 4 User Reviews 8.2 Rate it!} } contemporary
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