About ARCALYST

ARCALYST® (rilonacept) is a prescription medicine called an interleukin-1 (IL-1) blocker. ARCALYST is used to treat adults and children 12 years of age and older with Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS).


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.


CAPS are characterized by lifelong, recurrent symptoms of rash, fever/chills, joint pain, eye redness/pain, and fatigue.

  • The symptoms of CAPS may be challenging to diagnose. The diagnosis may be delayed because CAPS are rare and the symptoms often resemble those of other disorders
  • Intermittent symptom flares may be triggered anytime by cooling temperatures, stress, exercise, or unidentified causes
  • Some patients may try to reduce their symptoms by avoiding things that trigger the disease

See Full Prescribing Information

Reimbursement Assistance

Regeneron Pharmaceuticals, the maker of ARCALYST® (rilonacept), provides insurance reimbursement assistance to patients who are or will be treated with ARCALYST. Call 1-877-REGN-777 (1-877-734-6777); select Option 2 and then Option 4.

The program:

  • Assists with benefit investigations. A case manager will contact the patient's insurance provider to conduct a benefit investigation to determine coverage for ARCALYST therapy
  • Assists with prior authorizations. A case manager can provide guidance and assistance to patient and healthcare providers on the prior authorization process. Should the patient's insurance provider deny the prior authorization, the case manager can assist with appealing the decision until resolution
  • Makes referrals to independent patient support organizations. A case manager can refer the patient to independent foundations that might be able to provide assistance with concerns about out-of-pocket expenses
  • Coordinates alternative coverage. If the patient's insurance provider does not cover therapy, a case manager will help the patient find alternative coverage or access a company-sponsored patient assistance program that offers ARCALYST at no charge to patients without insurance who meet certain income requirements

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.

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777 Old Saw Mill River Road
Tarrytown, NY 10591-6707
Copyright © 2018, Regeneron Pharmaceuticals, Inc. January 2018 US-ARC-13325
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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.