Safety Information

Helping you understand the key facts

What important information should I know about ARCALYST®
(rilonacept)?

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.

You should not take medicines that block tumor necrosis factor (TNF), such as Cimzia® (certolizumab), Enbrel® (etanercept), Humira® (adalimumab), Remicade® (infliximab), or Simponi® (golimumab), while you are taking ARCALYST. You should also not take other medicines that block interleukin-1 (IL-1), such as Kineret® (anakinra) or Ilaris® (canakinumab), while taking ARCALYST. Taking ARCALYST with any of these medicines may increase your risk of getting a serious infection.

Cimzia®, Enbrel®, Humira®, Ilaris®, and Kineret® are registered trademarks of UCB Group of Companies, Amgen Inc., Abbott Laboratories, Novartis Pharmaceuticals Corporation, and Biovitrum AB (publ), respectively. Remicade® and Simponi® are registered trademarks of Janssen Biotech, Inc.


ARCALYST may not be right for you. 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
  • 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

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.


Tell your healthcare provider about all the medicines you take, including prescription and nonprescription 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) or Ilaris® (canakinumab)
  • Medicines that block TNF, such as Cimzia® (certolizumab), Enbrel® (etanercept), Humira® (adalimumab), Remicade® (infliximab), or Simponi® (golimumab)
  • Corticosteroids, such as prednisone

Cimzia®, Enbrel®, Humira®, Ilaris®, and Kineret® are registered trademarks of UCB Group of Companies, Amgen Inc., Abbott Laboratories, Novartis Pharmaceuticals Corporation, and Biovitrum AB (publ), respectively. Remicade® and Simponi® are registered trademarks of Janssen Biotech, Inc. 


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.


What are the possible serious side effects of ARCALYST?


Serious side effects may occur while you are taking and for some time after you have finished taking ARCALYST, including

  • Serious Infections. Treatment with ARCALYST 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:
    • — 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

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 are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.


Regeneron Pharmaceuticals is available to assist patients with


  • Questions about CAPS and ARCALYST treatment and administration
  • Possible side effects
  • Product complaints

Call 1-877-REGN-777 (1-877-734-6777)

Reimbursement Assistance

We provide insurance reimbursement assistance to eligible patients being treated with ARCALYST.

LEARN ABOUT THE PROGRAM

Important Safety Information

ARCALYST® (rilonacept) 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.

You should not take medicines that block Tumor Necrosis Factor (TNF) or IL-1 while taking ARCALYST. Taking ARCALYST with any of these medicines may increase your risk of getting a serious infection.

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

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 healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The impact of treatment with ARCALYST on active and/or chronic infections and the development of malignancies (cancer) is not known. However, treatment with immunosuppressants, including ARCALYST, may increase the risk of malignancies.

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

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.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Indication

ARCALYST® (rilonacept) is a prescription medicine called an interleukin-1 (IL-1) blocker. ARCALYST 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).

Please see the full Prescribing Information for ARCALYST.

The information contained herein is provided for general educational purposes. If you have any questions, talk to your doctor.

Copyright © 2018,
Regeneron Pharmaceuticals, Inc. May 2018 US-ARC-13325(1)

Important Safety Information
and Indication

ARCALYST® (rilonacept) 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.