ARCALYST is a once-weekly, self-administered treatment. 

ARCALYST is given by injection under the skin (subcutaneous injection) 1 time each week. A healthcare provider will tell you how much ARCALYST to take. Kiniksa One Connect can work with you to set up one-on-one injection training sessions with an ARCALYST Nurse Educator so you are familiar with the administration process.  Do not try to give yourself ARCALYST injections until you are sure that you understand how to prepare and inject your dose. Call your healthcare provider, pharmacist, or Kiniksa One Connect at 1-833-KINIKSA (1-833-546-4572) if you have any questions. 

Keep ARCALYST in the carton it comes in to protect it from light. Store ARCALYST in the refrigerator between 36 °F and 46 °F (2 °C and 8 °C). Refrigerated ARCALYST can be used until the expiration date printed on the vial and carton. ARCALYST may be kept at room temperature after mixing and should be used within 3 hours of mixing. 

If you miss a dose, you should speak with your healthcare provider. 

Give yourself the injection within 7 days from the missed dose and then resume your original schedule. If the missed dose is not given within 7 days, give yourself the dose, starting a new schedule based on this date.

Your Patient Access Lead will help you coordinate the delivery of your medication and supplies through Kiniksa One Connect.  

Before starting treatment with ARCALYST, tell the healthcare provider if you or your child:

• 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 (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 or your child begin treatment with ARCALYST, talk with the healthcare provider about your or your child’s vaccine history. Ask the healthcare provider whether you or your child should receive any vaccines, including the pneumonia vaccine and flu vaccine, before you or your child begin treatment with ARCALYST.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take other medicines that affect your immune system, such as corticosteroids. 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 risk of getting a serious infection.

Talk to your healthcare provider if you experience any side effects that bother you or that do not go away. Please report side effects by contacting Kiniksa Pharmaceuticals toll-free at 1-833-546-4572, Option 3 or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

It is not known if ARCALYST will harm your unborn child or if it can pass into your breast milk. Tell your healthcare provider right away if you become pregnant while taking ARCALYST and talk about the best way to feed your baby during treatment with 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 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, show 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 get a serious infection.

Kiniksa One Connect is a support program made up of a team of dedicated Patient Access Leads who provide personalized one-on-one support at each step of your treatment journey with ARCALYST. You can find services to help you with starting treatment, financial assistance, and treatment support. You can contact Kiniksa One Connect at 1-833-KINIKSA (1-833-546-4572) Monday-Friday (8 AM – 8 PM ET). 

ARCALYST Nurse Educators are qualified personnel who can assist you with virtual training to help you better understand the self-injection process.