Arcalyst

PATIENT INFORMATION

ARCALYST™
(ARK-a-list)
(rilonacept)

Injection for Subcutaneous Use

Read the patient information that comes with ARCALYST (rilonacept) before you start taking it and each time you refill your prescription. There may be new information. The information in this leaflet does not take the place of talking with your healthcare provider about your medical condition and your treatment.

What is the most important information I should know about ARCALYST (rilonacept) ?

ARCALYST (rilonacept) can affect your immune system. ARCALYST (rilonacept) 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 (rilonacept) . Taking ARCALYST (rilonacept) 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 (rilonacept) if you have an infection or have infections that keep coming back (chronic infection).

After starting ARCALYST (rilonacept) , 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 health care providerrightaway. Treatment with ARCALYST (rilonacept) should be stopped if you develop a serious infection.

You should not takemedicines 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 (rilonacept) . Taking ARCALYST (rilonacept) with any of these medicines may increase your risk of getting a serious infection. Before starting treatment with ARCALYST (rilonacept) , 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
  • haveasthma. 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

Before you begin treatment with ARCALYST (rilonacept) , 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 (rilonacept) .

What is ARCALYST (rilonacept) ?

ARCALYST (rilonacept) is a prescription medicine called an interleukin-1 (IL-1) blocker. ARCALYST (rilonacept) is used to treat adults and children 12 years and older with Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle Wells Syndrome (MWS). ARCALYST (rilonacept) can help lessen the signs and symptoms of CAPS, such as rash, joint pain, fever, and tiredness, but it can also lead to serious side effects because of the effects on your immune system.

What should I tell my healthcare provider before taking ARCALYST (rilonacept) ?

ARCALYST (rilonacept) may not be right for you. Before taking ARCALYST (rilonacept) , 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 (rilonacept) .
  • are pregnant or planning to become pregnant. It is not known if ARCALYST (rilonacept) will harm your unborn child. Tell your healthcare provider right away if you become pregnant while taking ARCALYST (rilonacept) .
  • are breast-feeding or planning to breast-feed. It is not known if ARCALYST (rilonacept) passes into your breast milk.

See “What is the most important information I should know about ARCALYST (rilonacept) ?”

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.

See “What is the most important information I should know about ARCALYST (rilonacept) ?”

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.

How should I take ARCALYST (rilonacept) ?

See the “Patient Instructions for Use” at the end of this leaflet.

  • Take ARCALYST (rilonacept) exactly as prescribed by your healthcare provider.
  • ARCALYST (rilonacept) is given by injection under the skin (subcutaneous injection) one time each week.
  • Your healthcare provider will tell and show you or your caregiver:
    • how much ARCALYST (rilonacept) to inject
    • how to prepare your dose
    • how to give the injection
  • 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 (rilonacept) , 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 (rilonacept) than prescribed, call your healthcare provider.

What are the possible side effects of ARCALYST (rilonacept) ?

Serious side effects may occur while you are taking and after you finish taking ARCALYST (rilonacept) including:

  • Serious Infections. See “What is the most important information I should know about taking ARCALYST (rilonacept) ?” Treatment with ARCALYST (rilonacept) should be discontinued if you develop a serious infection.
  • 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 (rilonacept) :
    • rash
    • swollen face
    • trouble breathing

Common side effects with ARCALYST (rilonacept) 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.

These are not all the possible side effects of ARCALYST (rilonacept) . 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 report side effects to FDA at 1-800-FDA-1088.

How should I store ARCALYST (rilonacept) ?

  • Keep ARCALYST (rilonacept) in the carton it comes in.
  • Store ARCALYST (rilonacept) in a refrigerator between 36°F to 46°F (2°C to 8°C). Call your pharmacy if you have any questions.
  • Always keep ARCALYST (rilonacept) away from light.
  • Refrigerated ARCALYST (rilonacept) can be used until the expiration date printed on the vial and carton.
  • ARCALYST (rilonacept) may be kept at room temperature after mixing. ARCALYST (rilonacept) should be used within three hours of mixing. Keep ARCALYST (rilonacept) away from light.
  • If you need to take ARCALYST (rilonacept) with you when traveling, store the carton in a cool carrier with a cold pack and protect it from light.

Keep ARCALYST (rilonacept) , injection supplies, and all other medicines out of reach of children.

What are the ingredients in ARCALYST?

Active ingredient: rilonacept.

Inactive ingredients: histidine, arginine, polyethylene glycol 3350, sucrose, and glycine.

General Information about ARCALYST (rilonacept)

Medicines are sometimes prescribed for conditions other than those listed in patient information leaflets. Do not use ARCALYST (rilonacept) for a condition for which it was not prescribed. Do not give ARCALYST (rilonacept) to other people even if they have the same condition. It may harm them.

This leaflet summarizes the most important information about ARCALYST (rilonacept) . If you would like more information, speak with your healthcare provider. You can ask your healthcare provider or pharmacist for information about ARCALYST (rilonacept) that was written for healthcare professionals. For more information about ARCALYST (rilonacept) , call 1-877-REGN-777 (1-877-734-6777), or visit www.ARCALYST (rilonacept) .com.

Patient Instructions for Use

It is important for you to read, understand and follow the instructions below exactly. Following the instructions correctly will help to make sure that you use prepare and inject the medicine the right way to prevent infection.

How do I prepare and give an injection of ARCALYST (rilonacept) ?

STEP 1: Setting up for an injection

1. 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 Figure 1):

Figure 1

Setting up for an injection - Illustration

  • 2 sterile, 3-milliliter (mL) disposable syringes with markings at each 0.1 mL (see Figure 2):
  • one needed for mixing (reconstitution) ARCALYST (rilonacept)
  • one needed for injection

Figure 2

Disposable syringes with markings - Illustration

  • 2 sterile disposable needles (27 gauge ½ inches)
  • one needed for mixing
  • one needed for injection
  • 4 alcohol wipes
  • 1 2x2 gauze pad
  • 1 vial of ARCALYST (rilonacept) (powder 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 pharmacy if you need replacement syringes or needles.
  • Do not to 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, throwaway 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 proof container right after use. Do not try to recap the needle.

STEP 2: Preparing Vials

1. Check the expiration date on the carton of ARCALYST (rilonacept) . Do not use the vial if the expiration date has passed. Contact your 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 pharmacy for assistance.

3. 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 Figure 3).

Figure 3

Use one wipe for each vial - Illustration

5. Open the wrapper that contains the 27-gauge needle by pulling apart the tabs and set it aside 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 Figure 4).

Figure 4

Hold the barrel of the syringe with one hand and twist the 27-gauge needle - Illustration

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 Figure 5).

Figure 5

Fill the syringe with air Illustration

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) your medicine. Hold the Sterile Water vial on a firm surface with your other hand. Slowly insert the needle straight through the rubber stopper. Do not bend the needle. Push the plunger in all the way to push the air into the vial (see Figure 6).

Figure 6

Push the plunger in all the way - Illustration

8. 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 Figure 7).

Figure 7

Withdraw the Sterile Water from the vial  - Illustration

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 Figure 8).

Figure 8

Check the syringe - Illustration

13. Carefully remove the syringe with needle from the Sterile Water vial. Do not touch the needle.

STEP 3: Mixing (Reconstituting) ARCALYST (rilonacept)

1. With one hand, hold the ARCALYST (rilonacept) 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 rubber stopper of the ARCALYST (rilonacept) 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 Figure 9).

Figure 9

Direct the water stream to gently go down - Illustration

4. Remove the syringe and needle from the stopper and throwaway the needle, syringe, and Sterile Water vial in the puncture resistant container. Do not try to put the needle cover back on the needle.

5. 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 Figure 10).

Figure 10

Hold the vial containing the ARCALYST and sterile water for injection sideways - Illustration

6. 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 (rilonacept) 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 Figure 11).

NOTE: Contact your pharmacy to report any mixed ARCALYST (rilonacept) that is discolored or contains particles.

Figure 11

Do not use the mixed liquid if it is discolored or cloudy - Illustration

11. ARCALYST (rilonacept) may be kept at room temperature after mixing. ARCALYST (rilonacept) should be used within three hours of mixing. Keep ARCALYST (rilonacept) away from light.

STEP 4: Preparing the injection

1. Hold the ARCALYST (rilonacept) vial on a firm surface and wipe the top of the ARCALYST (rilonacept) vial with a new alcohol wipe (see Figure 12).

Figure 12

Wipe the top of the ARCALYST vial with a new alcohol wipe - Illustration

2. Take a new sterile, disposable needle and attach securely to a new syringe without removing the needle cover (see Figure 13).

Figure 13

Attach securely to a new syringe - Illustration

3. The amount of air you draw into the syringe should equal the amount of mixed ARCALYST (rilonacept) that your healthcare provider has prescribed for you to inject.

4. 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 (rilonacept) that your healthcare provider has prescribed for you to inject (see Figure 14).

Figure 14

Pull back the plunger on the syringe - Illustration

5. Remove the needle cover and be careful not to touch the needle. Keep the ARCALYST (rilonacept) 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 Figure 15).

Figure 15

Slowly insert the needle straight down -  Illustration

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 Figure 16).

Figure 16

Slowly pull back on the plunger to the mark - Illustration

NOTE: The maximum adult dose of ARCALYST (rilonacept) is 2 mL.

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 Figure 17).

It is important to remove air bubbles so that you withdraw up the right amount of medicine from the vial.

Figure 17

Remove air bubbles - Illustration

9. 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. Throwaway the ARCALYST (rilonacept) vial in the puncture resistant container even if there is any medicine left in the vial (see Figure 18). Do not use any vial of ARCALYST (rilonacept) more than one time.

Figure 18

Throwaway the ARCALYST vial in the puncture resistant container - Illustration

STEP 5: Giving the Injection

1. ARCALYST (rilonacept) 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 (rilonacept) 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 Figure 19):
    (Do not inject within a 2-inch area around the navel)

Figure 19

Injection sites- Illustration

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.

5. With the other hand gently pinch a fold of skin at the cleaned site for injection (see Figure 20).

Figure 20

Gently pinch a fold of skin - Illustration

6. Use a quick “dart like” motion to insert the needle straight into the skin (90 degree angle) (see Figure 20). 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 Figure 21).

Figure 21

Angle of Insertion - Illustration

7. After the needle is completely in the skin, let go of the skin that you are pinching.

8. 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” using new supplies (syringes, needles, vials, alcohol swabs and gauze pad).

9. If no blood appears, inject all the medicine n 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 Figure 22).

Figure 22

Hold a piece of sterile gauze over the injection site - Illustration

11. Do not replace the needle cover. Throw away the vials, used syringes and needles in the puncture-resistant container (see Figure 23). Do not recycle the container. DO NOT throwaway vials, needles, or syringes in the household trash or recycle.

Figure 23

Throw away the vials, used syringes and needles in the puncture-resistant container  - Illustration

12. Keep the puncture-resistant container out of reach of children. When the container is about two-thirds full, dispose of it as instructed by your 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) .

Last reviewed on RxList: 8/6/2009
This monograph has been modified to include the generic and brand name in many instances.

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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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