April 28, 2017
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Arcalyst Patient Information Including Side Effects

Brand Names: Arcalyst

Generic Name: rilonacept (Pronunciation: ril ON a sept)

What is rilonacept (Arcalyst)?

Rilonacept is used to treat some of the symptoms of rare genetic conditions such as Familial Cold Auto-inflammatory Syndrome (FCAS) or Muckle-Wells Syndrome (MWS).

FCAS and MWS are inflammatory disorders in which the body develops certain symptoms without a known cause (such as virus, bacteria, or illness). These symptoms include fever, chills, fatigue, and joint pain. More serious symptoms may involve the bones and joints, the central nervous system (deafness, vision loss, mental impairment), or major organs such as the kidneys.

Rilonacept may treat or prevent the symptoms of Familial Cold Auto-inflammatory Syndrome (FCAS) or Muckle-Wells Syndrome (MWS). However, this medication is not a cure for these inherited conditions.

Rilonacept may also be used for purposes not listed in this medication guide.

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

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Serious and sometimes fatal infections may occur during treatment with rilonacept. Call your doctor right away if you have any new signs of infection such as:

  • fever, chills, sore throat, flu symptoms;
  • easy bruising or bleeding (nosebleeds, bleeding gums);
  • nausea and vomiting, loss of appetite;
  • mouth sores; or
  • unusual weakness.

Call your doctor at once if you have any other serious side effect such as:

  • bloody, black, or tarry stools;
  • coughing up blood or vomit that looks like coffee grounds;
  • wheezing, chest tightness, trouble breathing;
  • pain or burning when you urinate; or
  • headache, neck stiffness, increased sensitivity to light, purple spots on the skin, and/or seizure (convulsions).

Other common side effects may include:

  • cold symptoms such as stuffy nose, sneezing, cough, sore throat;
  • nausea, stomach pain, diarrhea;
  • numbness or tingly feeling; or
  • pain, swelling, redness, itching, warmth, blistering, bleeding, or other irritation where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Arcalyst (rilonacept) Side Effects Center for a complete guide to possible side effects

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

Serious and sometimes fatal infections may occur during treatment with rilonacept. Call your doctor right away if you have signs of infection such as: fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), loss of appetite, nausea and vomiting, mouth sores, or unusual weakness.

You should not use this medication if you are allergic to rilonacept, or if you have any type of infection.

Before using rilonacept, tell your doctor if you have an active or chronic infection, a history of tuberculosis or recurrent infections, or high cholesterol or triglycerides. Make sure you are current on all vaccines before you start treatment with rilonacept.

Tell your doctor about all other medications you use, especially drugs to treat arthritis, psoriasis, Crohn's disease, or ankylosing spondylitis.

Do not receive a "live" vaccine while using rilonacept. The vaccine may not work as well during this time, and may not fully protect you from disease. Avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you.

Side Effects Centers

Additional Arcalyst Information

Report Problems to the Food and Drug Administration


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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