Arcalyst contains the active ingredient rilonacept, a dimeric fusion protein related to the interleukin-1 receptor. It is supplied as a lyophilized powder in single-dose vials, intended for reconstitution and subcutaneous administration. The drug is designed to be reconstituted with sterile water to deliver a dose of 160 mg per 2 mL solution. Key inactive ingredients include glycine, histidine, L-arginine, polyethylene glycol 3350, and sucrose.

How should I use this medication?

This medication is injected under the skin. It is usually given by a care team in a hospital or clinic setting. It may also be given at home. If you get this medication at home, you will be taught how to prepare and give it. Use exactly as directed. Keep taking it unless your care team tells you to stop.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or care team to get one.

This medication comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medication. Read the information carefully. Talk to your pharmacist or care team if you have questions.

Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 12 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss any doses. Talk to your care team about what to do if you miss a dose.

Where should I keep my medication?

Keep out of reach of children and pets.

If you are using this medication at home, store it in the refrigerator between 2 and 8 degrees C (36 and 46 degrees F). Do not freeze. Keep it in the original carton until you are ready to take it. Once removed from the carton, it must be used within 3 hours of mixing. Protect from light. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, ask your pharmacist or care team how to get rid of this medication safely.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Cough
• Diarrhea
• Nausea
• Numbness, decrease in sense of touch or sensation
• Pain, redness, or irritation at injection site
• Sinus pain or pressure around the face or forehead

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Diabetes (high blood sugar)
• Hepatitis
• High cholesterol
• HIV or AIDs
• Immune system problems
• Infection, such as tuberculosis (TB) or other bacterial, fungal, or viral infections
• Lung or breathing disease (asthma)
• Recent or upcoming vaccine
• An unusual or allergic reaction to rilonacept, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

What may interact with this medication?

Do not take this medication with any of the following:

• Biologic medications, such as adalimumab, anakinra, certolizumab, etanercept, golimumab, infliximab
• Live virus vaccines

This medication may also interact with the following:

• Medications that lower your chance of fighting infection
• Steroid medications, such as prednisone or cortisone
• Warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

You may need blood work done while taking this medication.

This medication can decrease the response to a vaccine. If you need to get vaccinated, tell your care team if you have received this medication.

This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

Talk to your care team about your risk of cancer. You may be more at risk for certain types of cancer if you take this medication.