safety
What is the most important information I should know about ARCALYST?
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 people 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 the healthcare provider right away. Treatment with ARCALYST should be stopped if you get a serious infection.
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. 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’s risk of getting a serious infection.
Before starting treatment with ARCALYST, tell the 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. People with asthma may have an increased risk of infection
- Have diabetes or an immune system problem. People with these problems have a higher chance for infections
- Have tuberculosis, 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 the healthcare provider about your vaccine history. Ask the healthcare provider whether you should receive any vaccines, including the pneumonia vaccine and flu vaccine, before you begin treatment with ARCALYST.

What are the possible side effects of ARCALYST?
ARCALYST can cause serious side effects, including:
- Risk of Cancer. Medicines that affect the immune system may increase the risk of getting cancer.
- Allergic Reaction. Stop taking or giving ARCALYST and call the healthcare provider or get emergency care right away if you get any of the following symptoms of an allergic reaction while taking ARCALYST:
- Rash
- Swollen face
- Trouble breathing
- Changes in your blood cholesterol and triglycerides (lipids). Your healthcare provider will do blood tests to check for these changes.
- In people with CAPS and RP, the most common side effects of ARCALYST include:
- Injection-site reactions including: pain, redness, swelling, itching, bruising, lumps, inflammation, skin rash, blisters, warmth, and bleeding at the injection site.
- Upper respiratory tract infections
- Joint and muscle aches in RP
- In people with DIRA, the most common side effects of ARCALYST include:
- Upper respiratory tract infections
- Rash
- Ear infection
- Sore throat
- Runny nose
These are not all the possible side effects of ARCALYST. Tell your healthcare provider if you have any side effect that bothers you or does not go away. For more information, ask your healthcare provider or pharmacist.