777 Old Saw Mill River Road Tarrytown, NY Copyright 2008, Regeneron Pharmaceuticals, Inc. ARC-0007-PB-10.09

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1 REG43214_Patient_Covers_FINAL:Layout 1 10/13/08 1:18 PM Page 1 References 1. ARCALYST (rilonacept) for Subcutaneous Injection full Prescribing Information. 2. Aksentijevich I, Putnam CD, Remmers EF, Mueller JL et al. The clinical continuum of cryopyrinopathies. Novel CIAS1 mutations in North American patients and a new cryopyrin model. Arthritis Rheum. 2007;56: Hoffman HM. Hereditary immunologic disorders caused by pyrin and cryopyrin. Curr Allergy Asthma Rep. 2007;7: Stych B, Dobrovolny D. Familial cold auto-inflammatory syndrome (FCAS): charachterization of symptomalogy and impact on patients lives. Curr Med Res Opin. 2008;24(6): Data on file, Regeneron Pharmaceuticals, Inc. 6. Hoffman HM, Wanderer AA, Broide DH. Familial cold auto-inflammatory syndrome: phenotype and genotype of an autosomal dominant periodic fever. J Allergy Clin Immunol. 2001;108: Aganna E, Martinon F, Hawkins PN, et al. Association of mutations in the NALP3/CIAS1/PYPAF1 gene with a broad phenotype including recurrent fever, cold sensitivity, sensorineural deafness, and AA amyloidosis. Arthritis Rheum. 2002;46: Gerbig AW, Dahinden CA, Mullis P, Hunziker T. Circadian elevation of IL-6 levels in Muckle-Wells syndrome: a disorder of the neuro-immune axis? QJM. 1998;91: Hawkins PN, Lachmann HJ, Aganna E, McDermott MF. Spectrum of clinical features in Muckle-Wells Syndrome and response to anakinra. Arthritis Rheum. 2004;50: Treatment Guide 777 Old Saw Mill River Road Tarrytown, NY Copyright 2008, Regeneron Pharmaceuticals, Inc. ARC-0007-PB All rights reserved Printed in USA 10/08

2 REG43214_Patient_Covers_FINAL:Layout 1 10/13/08 1:18 PM Page 4 CONTENTS Introduction 1 Cryopyrin-Associated Periodic Syndromes (CAPS) 2 How ARCALYST (rilonacept) works 6 Effectiveness of ARCALYST 7 Most important things to know before taking ARCALYST 9 Things to tell your healthcare provider before taking ARCALYST 12 Possible side effects of ARCALYST 14 How to take ARCALYST 16 Storing ARCALYST 17 Injecting ARCALYST 19 Ongoing treatment with ARCALYST: You are not alone 36 ARCALYST is a registered trademark of Regeneron Pharmaceuticals, Inc. ENBREL (etanercept), Humira (adalimumab), Remicade (infliximab), and Kineret (anakinra) are trademarks of Immunex Corporation, Abbott Laboratories, Centocor, Inc., and Amgen, respectively.

3 REG43214_Patient_Covers_FINAL:Layout 1 10/13/08 1:18 PM Page 7 ONGOING TREATMENT WITH ARCALYST (rilonacept) 1 : YOU ARE NOT ALONE There are a number of resources available to help you with the symptoms of CAPS and the use of ARCALYST: Your doctor or healthcare provider is familiar with CAPS and treatment with ARCALYST, and should be contacted immediately with any questions or concerns. If you have access to the Internet, visit a valuable resource for physicians, patients, families, and caregivers. There is also information available at or through the Regeneron Medical Information helpline at REGN-777 ( ), option 2. REGENERON is providing a reimbursement hotline for CAPS patients on ARCALYST. You may call the Regeneron reimbursement hotline at REGN-777, option 4. To participate in an ongoing pediatric patient registry (age 17 or younger), please call REGN-777, option 2. Report possible side effects or any product complaints to REGN-777, option 3. INTRODUCTION This brochure is about ARCALYST (rilonacept) Injection for Subcutaneous Use, a medicine (known as an interleukin-1 blocker) used for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Auto-inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS), in adults and children age 12 and older. 1 The purpose of this brochure is to provide you with information about CAPS and about ARCALYST. This brochure will help you get started taking ARCALYST and will be a valuable resource to you throughout your treatment. REGENERON is committed to working with you toward a successful treatment with ARCALYST. 36 1

4 REG43214_Patient_Covers_FINAL:Layout 1 10/13/08 1:18 PM Page 9 CRYOPYRIN-ASSOCIATED PERIODIC SYNDROMES (CAPS) Over the years, a small group of patients across the country have been challenged with coping with the life-long, fluctuating, unexplained, recurrent symptoms of rash, fever/chills, fatigue, joint pain/arthritis, and eye redness/pain, accompanied by inflammation. 2 Only recently have medical researchers identified the underlying basis of a particular group of very rare, inherited disorders known as Cryopyrin- Associated Periodic Syndromes (or CAPS) that are characterized by these symptoms. 2 CAPS are generally caused by alterations (called mutations) in a gene NLRP-3, previously known as CIAS1, that is active in circulating, infectionfighting, white blood cells. 3 The NLRP-3 gene controls the production of a protein called cryopyrin (meaning icy fire to describe the fiery symptoms that can result from its inappropriate production oftentimes related to cold exposure). Cryopyrin, in turn, controls the production of a protein called interleukin-1 (IL-1 ). As part of the body s infection-fighting defense system, IL-1 circulates throughout the body and can trigger inflammatory reactions when it binds to inflammatory cells. Researchers have found that alterations in the NLRP-3 gene leads to the over-production of IL-1. This overproduction results in an inflammatory response, causing the Notes: 2 35

5 REG43214_Patient_Covers_FINAL:Layout 1 10/13/08 1:18 PM Page Do not replace the needle cover. Throw away the vials, used syringes and needles in the puncture-resistant container (see Fig. 24). Do not recycle the container. DO NOT throw away vials, needles, or syringes in the household trash or recycle. 12. Keep the punctureresistant container out of reach of children. When the container is about two-thirds full, dispose of it as instructed by your Fig. 24 healthcare provider. Follow any special state or local laws about the right way to throw away needles and syringes. 13. Used alcohol wipes can be thrown away in the household trash. Contact your healthcare provider right away with any questions or concerns about ARCALYST (rilonacept). symptoms and consequences of CAPS (see Fig. 1). 2 Figure 1: Cause of CAPS 2,3 Inflammatory Cells NLRP-3 gene Altered cryopyrin production IL-1 overproduction Inflammation and CAPS symptoms Gene mutation Three related conditions make up the broader disorder known as CAPS 2 : Familial Cold Auto-inflammatory Syndrome (FCAS), also known as Familial Cold Urticaria (FCU) Muckle-Wells Syndrome (MWS) Neonatal-Onset Multisystem Inflammatory Disease (NOMID), also known as Chronic Infantile Neurologic Cutaneous Articular Syndrome (CINCA) ARCALYST has not been studied in NOMID/CINCA. 34 3

6 REG43214_Patient_Covers_FINAL:Layout 1 10/13/08 1:19 PM Although the conditions of CAPS (Cryopyrin-Associated Periodic Syndromes) have over-lapping symptoms, there are some differences in the symptoms and possible disease consequences.2 The life-long symptoms of CAPS and the ongoing risk of disease flares have a significant CAPS Signs & FCAS 95% onset <6 months of age6 Recurrent symptoms triggered by exposure to cold temperatures or a slight drop in temperature, including air conditioning6 - Rash6 - Fever and chills6 - Joint pain6 - Eye redness and pain5 - Fatigue7 Elevations of markers of inflammation in the blood1 Duration of most attacks <24 hours6 Page With your free hand hold the syringe near its base. Gently pull back the plunger. If blood comes into the syringe, the needle has entered a blood vessel. Remove the needle, discard the syringe and needle. Start over with STEP 1: Setting Up For an Injection Symptom using new supplies (syringes, needles, vials, alcohol swabs MWS and gauze pad). 9. If no blood appears, inject all the medicine in the syringe at a slow, steady rate, pushing the plunger all the way down. It may take up to 30 seconds to inject the entire dose. 10. Pull the needle out of the skin, and hold a piece of sterile gauze over the injection site for several seconds (see Fig. 23). Possible Consequences Fig. 23 Limited daily activities3,4 In rare cases, kidney complications3 4 Fig

7 REG43214_Patient_Covers_FINAL:Layout 1 10/13/08 2. Choose the area for the injection. Clean the area in a circular motion with a new alcohol wipe. Begin at the center of the site and move outward. Let the alcohol air dry completely. 3. Take the cover off the needle and be careful not to touch the needle. 4. Hold the syringe in one hand like you would hold a pencil. 1:19 PM Page 15 impact on patients daily activities. A recent patient research survey of 30 patients diagnosed with FCAS revealed that patients abilities to participate in work, home, family, and social activities are limited by both their disease symptoms, as well as their efforts to avoid debilitating disease flares.4 & Symptoms MWS 85% onset <20 years of age6 Recurrent symptoms triggered by random unknown factors and possibly by stress, exercise, and cold3 - Rash2 - Fever and chills8 - Joint inflammation and joint pain9 - Eye redness and pain3 - Fatigue2 Elevations of markers of inflammation in the blood1 Duration of most attacks hours3 Fig With the other hand gently pinch a fold of skin at the cleaned site for injection (see Fig. 20). 6. Use a quick dart like motion to insert the needle straight into the skin (90 degree angle) (see Fig. 21). Do not push down on the plunger while inserting the needle into the skin. For small children or persons with little fat under the skin, you may need to hold the syringe and needle at a 45 degree angle (see Fig. 22). Fig After the needle is completely in the skin, let go of the skin that you are pinching. Possible Consequences Limited daily activities3,5 Risk of kidney complications3 Hearing loss3 32 5

8 REG43214_Patient_Covers_FINAL:Layout 1 10/13/08 1:19 PM Page 17 HOW ARCALYST (rilonacept) WORKS 1 The symptoms of CAPS occur when excess interleukin-1 (IL-1 ) is released into the bloodstream. IL-1 binds to its receptors on inflammatory cells leading to inflammation. Before Treatment ARCALYST binds interleukin-1 in the blood circulation and prevents its interaction with receptors on cells, including those cells involved in the inflammatory process. As a result ARCALYST helps reduce inflammation and resultant CAPS symptoms. With ARCALYST Treatment STEP 5: Giving the Injection 1 1. ARCALYST is given by subcutaneous injection, an injection that is given into the tissue directly below the layers of skin. It is not meant to go into any muscle, vein, or artery. You should change (rotate) the sites and inject in a different place each time in order to keep your skin healthy. Rotating injection sites helps to prevent irritation and allows the medicine to be completely absorbed. Ask your healthcare provider any questions that you have about rotating injection sites. Do not inject into skin that is tender, red, or hard. If an area is tender or feels hardened, choose another site for injection until the tenderness or "hardening" goes away. Tell your healthcare provider about any skin reactions including redness, swelling, or hardening of the skin. Areas where you may inject ARCALYST include the left and right sides of the abdomen, and left and right thighs. If someone else is giving the injection, the upper left and right arms may also be used for injection (see Fig. 19). Fig. 19 (Do not inject within a 2-inch area around the navel) 6 31

9 REG43214_Patient_Covers_FINAL:Layout 1 10/13/08 8. Keep the vial upside down with the needle straight up, and gently tap the syringe until any air bubbles rise to the top of the syringe (see Fig.17). It is important to remove air bubbles so that you withdraw the right amount of medicine from the vial. Fig To remove the air bubbles, slowly and gently push in the plunger so only the air is pushed through the needle. 10. Check to make sure that you have the amount of medicine prescribed by your healthcare provider in the syringe. 11. Throw away the ARCALYST (rilonacept) vial in the puncture-resistant container even if there is any medicine left in the vial (see Fig. 18). Do not use any vial of ARCALYST more than one time. Fig. 18 1:19 PM Page 19 EFFECTIVENESS OF ARCALYST1 ARCALYST is approved for the treatment of CAPS, including Familial Cold Auto-inflammatory Syndrome and Muckle-Wells Syndrome, in adults and children 12 and over. In a two-part study conducted with ARCALYST in a group of 47 patients suffering from these two conditions, ARCALYST was compared with a dummy injection (a placebo). The patients were randomly assigned to receive ARCALYST or placebo, and neither the patients nor the investigators knew who was taking ARCALYST or placebo. This kind of study is known as blinded. The purpose of blinding the study is to avoid bias. When the results of the first part of the study were unblinded, it was found that the patients who were taking ARCALYST had much better improvement than the placebo patients in a composite score evaluating symptoms of CAPS: rash, joint pain, fever/chills, eye pain/redness, and fatigue. In general, the benefit started very early in the treatment. Signs of inflammation in the blood also returned to normal levels in patients receiving ARCALYST. The most commonly reported adverse reactions were injection site reaction and upper respiratory tract infection. Serious infections have happened in patients receiving ARCALYST. 30 7

10 REG43214_Patient_Covers_FINAL:Layout 1 10/13/08 1:19 PM Page 21 In a subsequent, 9-week part of the study, patients who stopped taking ARCALYST and were switched to placebo gradually experienced a return of CAPS symptoms, whereas those remaining on ARCALYST continued to experience symptom control. In response to questionnaires administered during a follow-up study in which all patients received ARCALYST, patients reported improvement in their ability to participate in daily work, home, and family activities previously limited by their symptoms. 5 The most commonly reported adverse reactions in patients with CAPS treated with ARCALYST were injection site reaction (pain, redness, swelling, itching, bruising, lumps, inflammation, skin rash, blisters, warmth, and bleeding at the injection site) and upper respiratory tract infection. 1 Please see the POSSIBLE SIDE EFFECTS OF ARCALYST on page 14 and the MOST IMPORTANT THINGS TO KNOW BEFORE TAKING ARCALYST on page 9 for additional safety information. Please see the accompanying full Prescribing Information and Patient Package Insert for ARCALYST (rilonacept). 6. Hold the vial in one hand and the syringe in the other hand and carefully turn the vial upside down so that the needle is pointing straight up. Hold the vial at eye level. 7. Keep the tip of the needle in the liquid and slowly pull back on the plunger to the mark on the syringe that matches the amount of medicine prescribed by your healthcare provider (see Fig. 16). Note: The maximum amount (volume) of ARCALYST in any single subcutaneous injection is 2mL. Fig

11 REG43214_Patient_Covers_FINAL:Layout 1 10/13/08 Note: Contact your Specialty Pharmacy to report any mixed ARCALYST (rilonacept) that is discolored or contains particles. 3. The amount of air you draw into the syringe should equal the amount of mixed ARCALYST that your healthcare provider has prescribed for you to inject. Fig To draw air into the syringe, hold the syringe at eye level. Do not remove the needle cover. Pull back the plunger on the syringe to the mark that is equal to the amount of mixed ARCALYST that your healthcare provider has prescribed for you to inject (see Fig. 14). 5. Remove the needle cover and be careful not to touch the needle. Keep the ARCALYST vial on a flat surface and slowly insert the needle straight down through the stopper. Push the plunger down and inject all the air into the vial (see Fig. 15). 1:19 PM Page 23 MOST IMPORTANT THINGS TO KNOW BEFORE TAKING ARCALYST1 ARCALYST can affect your immune system. ARCALYST can lower the ability of your immune system to fight infections. Serious infections, including life-threatening infections and death have happened in patients taking ARCALYST. Taking ARCALYST can make you more likely to get infections, including life-threatening serious infections, or may make any infection that you have worse. You should not begin treatment with ARCALYST if you have an infection or have infections that keep coming back (chronic infection). After starting ARCALYST, if you get an infection, any sign of an infection including a fever, cough, flu-like symptoms, or have any open sores on your body, call your healthcare provider right away. Treatment with ARCALYST should be stopped if you develop a serious infection. Fig

12 REG43214_Patient_Covers_FINAL:Layout 1 10/13/08 You should not take medicines that block Tumor Necrosis Factor (TNF), such as ENBREL (etanercept), Humira (adalimumab), or Remicade (infliximab), while you are taking ARCALYST (rilonacept). You should also not take other medicines that block interleukin-1 (IL-1), such as Kineret (anakinra), while taking ARCALYST. Taking ARCALYST with any of these medicines may increase your risk of getting a serious infection. Based on these considerations, please carefully look at the following list of items. Check the ones that may apply to you to help you remember to discuss them with your doctor or healthcare provider. 1:19 PM Page 25 STEP 4: Preparing the Injection1 1. Hold the ARCALYST vial on a firm surface and wipe the top of the ARCALYST vial with a new alcohol wipe (see Fig. 12). 2. Take a new sterile, disposable needle and attach securely to a new syringe without removing the needle cover (see Fig. 13). Fig. 12 Before you begin treatment with ARCALYST, talk with your healthcare provider about your vaccination history. Ask your healthcare provider whether you should receive any vaccinations, including pneumonia vaccine and flu vaccine, before you begin treatment with ARCALYST. Fig

13 REG43214_Patient_Covers_FINAL:Layout 1 10/13/08 1:19 PM Page Hold the vial containing the ARCALYST (rilonacept) and Sterile Water for Injection sideways (not upright) with your thumb and a finger at the top and bottom of the vial, and quickly shake the vial back and forth (side-to-side) for about 1 minute (see Fig. 10). Fig Put the vial back on the table and let the vial sit for about 1 minute. 7. Look at the vial for any particles or clumps of powder which have not dissolved. 8. If the powder has not completely dissolved, shake the vial quickly back and forth for 30 seconds more. Let the vial sit for about 1 minute. 9. Repeat Step 8 until the powder is completely dissolved and the solution is clear. 10. The mixed ARCALYST should be thick, clear, and colorless to pale yellow. Do not use the mixed liquid if it is discolored or cloudy, or if small particles are in it (see Fig. 11). Fig ARCALYST may be kept at room temperature after mixing. ARCALYST should be used within three hours of mixing. Keep ARCALYST away from light. Before starting treatment with ARCALYST, tell your healthcare provider if you: think you have an infection are being treated for an infection have signs of an infection, such as fever, cough, or flu-like symptoms have any open sores on your body have a history of infections that keep coming back have asthma. Patients with asthma may have an increased risk of infection. have diabetes or an immune system problem. People with these conditions have a higher chance for infections. have tuberculosis (TB), or if you have been in close contact with someone who has had tuberculosis. have or have had HIV, Hepatitis B, or Hepatitis C take other medicines that affect your immune system IF YOU HAVE PLACED A CHECKMARK NEXT TO ANY OF THE ITEMS LISTED ABOVE, PLEASE DISCUSS THESE ITEMS WITH YOUR DOCTOR OR HEALTHCARE PROVIDER BEFORE YOU START TREATMENT WITH ARCALYST

14 REG43214_Patient_Covers_FINAL:Layout 1 10/13/08 1:19 PM Page 29 THINGS TO TELL YOUR HEALTHCARE PROVIDER BEFORE TAKING ARCALYST (rilonacept) 1 ARCALYST may not be right for you. Before taking ARCALYST, tell your healthcare provider about all of your medical conditions, including if you: are scheduled to receive any vaccines. You should not receive live vaccines if you take ARCALYST. are pregnant or planning to become pregnant. It is not known if ARCALYST will harm your unborn child. Tell your healthcare provider right away if you become pregnant while taking ARCALYST. are breast-feeding or planning to breast-feed. It is not known if ARCALYST passes into your breast milk. See MOST IMPORTANT THINGS TO KNOW BEFORE TAKING ARCALYST on page 9. Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take other medicines that affect your immune system, such as: other medicines that block IL-1, such as Kineret (anakinra) medicines that block Tumor Necrosis Factor (TNF), such as ENBREL (etanercept), Humira (adalimumab), or Remicade (infliximab) corticosteroids 12 STEP 3: Mixing (reconstituting) ARCALYST 1 1. With one hand, hold the ARCALYST vial on a firm surface. 2. With the other hand, take the syringe with the Sterile Water and the same needle, and slowly insert the needle straight down through the middle of the rubber stopper of the ARCALYST vial. Push the plunger in all the way to inject the Sterile Water into the vial. 3. Direct the water stream to gently go down the side of the vial into the powder (see Fig. 9). Fig Remove the syringe and needle from the stopper and throw away the needle, syringe, and Sterile Water vial in the punctureresistant container. Do not try to put the needle cover back on the needle. 25

15 REG43214_Patient_Covers_FINAL:Layout 1 10/13/08 1:19 PM Page 31 Fig. 7 Fig Hold the vial in one hand and the syringe in the other hand and carefully turn the vial upside down so that the needle is pointing straight up. 9. Make sure the tip of the needle is covered by the liquid and slowly pull back on the plunger to the 2.3 ml mark to withdraw the Sterile Water from the vial (see Fig. 7). 10. Keep the vial upside down and tap or flick the syringe with your fingers until any air bubbles rise to the top of the syringe. 11. To remove the air bubbles, gently push in the plunger so only the air is pushed out of the syringe and back into the bottle. 12. After removing the bubbles, check the syringe to be sure that the right amount of Sterile Water has been drawn into the syringe (see Fig. 8). 13. Carefully remove the syringe with needle from the Sterile Water vial. Do not touch the needle. See MOST IMPORTANT THINGS TO KNOW BEFORE TAKING ARCALYST on page 9. Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist every time you get a new prescription. If you are not sure or have any questions about any of this information, ask your healthcare provider. AGAIN, CHECK ALL BOXES ON PAGES 11 AND 12 THAT APPLY AND bring the list with you when you see your doctor or healthcare provider or TALK WITH your pharmacist so they can make sure that you will not have a negative drug interaction. Medicines Strength Dosing Times 24 13

16 REG43214_Patient_Covers_FINAL:Layout 1 10/13/08 POSSIBLE SIDE EFFECTS OF ARCALYST (rilonacept)1 You should not take ARCALYST if you ever had an allergic reaction to ARCALYST. Serious side effects may occur while you are taking and after you finish taking ARCALYST including: Serious Infections. Treatment with ARCALYST should be discontinued if you develop a serious infection. See MOST IMPORTANT THINGS TO KNOW BEFORE TAKING ARCALYST on page 9. Allergic Reaction. Call your healthcare provider or seek emergency care right away if you get any of the following symptoms of an allergic reaction while taking ARCALYST: rash swollen face trouble breathing Common side effects with ARCALYST include: Injection-site reaction. This includes: pain, redness, swelling, itching, bruising, lumps, inflammation, skin rash, blisters, warmth, and bleeding at the injection site. Upper respiratory infection. Changes in your blood cholesterol and triglycerides (lipids). Your healthcare provider will check you for this. 1:19 PM Page 33 for later use. Do not remove the needle cover. This needle will be used to mix the water with powder. Open the wrapper that contains the syringe by pulling apart the tabs. Hold the barrel of the syringe with one hand and twist the 27-gauge needle onto the tip of the syringe until it fits snugly with the other hand (see Fig. 4). 6. Hold the syringe at eye level. With the needle covered pull back the plunger to the 2.3 ml mark, filling the syringe with air (see Fig. 5). 7. Hold the syringe in one hand, use the other hand to pull the needle cover straight off. Do not twist the needle as you pull off the cover. Place the needle cover aside. Hold the syringe in the hand that you will use to mix (reconstitute) Fig. 6 your medicine. Hold the Sterile Water vial on a firm surface with your other hand. Slowly insert the needle straight through the middle of the rubber stopper. Do not bend the needle. Push the plunger in all the way to push the air into the vial (see Fig. 6). 14 Fig. 5 23

17 REG43214_Patient_Covers_FINAL:Layout 1 10/13/08 STEP 2: Preparing Vials1 1. Check the expiration date on the carton of ARCALYST (rilonacept). Do not use the vial if the expiration date has passed. Contact your Specialty Pharmacy for assistance. 2. Check the expiration date on the vial of Sterile Water for Injection. Do not use the vial if the expiration date has passed. Contact your Specialty Pharmacy for assistance. Fig Remove the protective plastic cap from both vials. 4. Clean the top of each vial with an alcohol wipe. Use one wipe for each vial and wipe in one direction around the top of the vial (see Fig. 3). 1:19 PM Page 35 These are not all the possible side effects of ARCALYST. Tell your healthcare provider about any side effects that bother you or that do not go away. For more information ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may also report side effects to the U.S. Food and Drug Administration (FDA) at FDA The ARCALYST Resource Center is available to assist patients with questions about: CAPS ARCALYST treatment ARCALYST administration possible side effects product complaints Call REGN-777 ( ) Fig Open the wrapper that contains the 27-gauge needle by pulling apart the tabs and set it aside 22 15

18 REG43214_Patient_Covers_FINAL:Layout 1 10/13/08 1:19 PM Page 37 HOW TO TAKE ARCALYST (rilonacept) 1 Take ARCALYST exactly as prescribed by your healthcare provider. ARCALYST is given by injection under the skin one time each week (this method is known as subcutaneous injection). Your healthcare provider will tell you and show you or your caregiver: how much ARCALYST to inject how to prepare your dose how to give the injection To help you get started on ARCALYST, a treatment kit containing all necessary supplies will be provided by your mail-order specialty pharmacy. This kit contains: Small bottles (vials) containing ARCALYST (powder or powder cake in vial) Disposable, sterile syringes (3mL) Disposable, sterile needles (27 gauge, 1/2-inch long) Alcohol wipes 2x2 gauze pads Vials of preservative-free Sterile Water for Injection Puncture-resistant container for disposal of used needles, syringes, and vials - one needed for mixing - one needed for injection 4 alcohol wipes 1 2x2 gauze pad 1 vial of ARCALYST (powder or powder cake in vial) 1 vial of preservative-free Sterile Water for Injection 1 puncture-resistant container for disposal of used needles, syringes, and vials Note: Do not use Sterile Water for Injection, syringes, or needles other than those provided by your pharmacy. Contact your Specialty Pharmacy if you need replacement syringes or needles. Do not touch the needles or the rubber stoppers on the vials with your hands. If you do touch a stopper, clean it with a fresh alcohol wipe. If you touch a needle or the needle touches any surface, throw away the entire syringe into the puncture-resistant container and start over with a new syringe. Do not reuse needles or syringes. To protect yourself and others from possible needle sticks, it is very important to throw away every syringe, with the needle attached, in the puncture-resistant container right after use. Do not try to recap the needle

19 REG43214_Patient_Covers_FINAL:Layout 1 10/13/08 1:19 PM Page 39 STEP 1: Setting Up For an ARCALYST (rilonacept) Injection 1 Fig Choose a table or other flat surface area to set up the supplies for your injection. Be sure that the area is clean or clean it with an antiseptic or soap and water first. 2. Wash your hands well with soap and water, and dry with a clean towel. 3. Put the following items on a table, or other flat surface, for each injection (see Fig. 1) 2 sterile, 3-milliliter (ml) disposable syringes with markings at each 0.1 ml (see Fig. 2) STORING ARCALYST 1 You should keep ARCALYST in the original carton and protect it from light until the time of use. Store ARCALYST in the refrigerator at 2 C to 8 C (36 F to 46 F). You can use refrigerated ARCALYST until the expiration date printed on the carton and the vial containing the powder. After ARCALYST is prepared for injection, it may be kept at room temperature after mixing. ARCALYST should be used within 3 hours of mixing. Keep ARCALYST away from light. If you need to take ARCALYST with you when traveling, store the carton in a cool carrier with a cold pack and protect it from light. Call your Specialty Pharmacy if you have questions. Always keep ARCALYST, the injection supplies, and all other medicines out of reach of children. Only use ARCALYST for the illness for which it was prescribed. Do not give ARCALYST to other people, even if they have the same illness. It may harm them. - one needed for mixing (reconstitution) ARCALYST - one needed for injection Fig. 2 2 sterile disposable needles (27 gauge, ½ inches) 20 17

20 REG43214_Patient_Covers_FINAL:Layout 1 10/13/08 1:19 PM Page 41 Do not try to give ARCALYST (rilonacept) injections until you are sure that you or your caregiver understands how to prepare and inject your dose. Call your healthcare provider or pharmacist if you have any questions about preparing and injecting your dose, or if you or your caregiver would like more training. If you miss a dose of ARCALYST, inject it as soon as you remember, up to the day before your next scheduled dose. The next dose should be taken at the next regularly scheduled time. If you have any questions, contact your healthcare provider. If you accidentally take more ARCALYST than prescribed, call your healthcare provider. This booklet summarizes the most important information about ARCALYST. If you would like more information, speak with your healthcare provider. You can ask your healthcare provider or pharmacist for information about ARCALYST that was written for healthcare professionals. For more information about ARCALYST, call REGN-777 ( ), or visit INJECTING ARCALYST 1 In order to inject ARCALYST, several steps need to be carefully followed. One of the most important things for you to remember is that ARCALYST comes in the form of a powder inside a vial. This powder should not be injected directly. You must mix the ARCALYST powder with the supplied sterile water as the first step in the preparation process (this step is known as reconstitution). You will then prepare the correct dose, and you will be ready to inject ARCALYST. It is important to follow the instructions exactly as they are given in this brochure. By following these instructions correctly, you will avoid possible contamination of the medicine, the supplies, and the skin at injection time

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