Arcalyst

This medication is used to treat a certain group of inherited disorders called cryopyrin-associated periodic syndromes (CAPS), including familial cold autoinflammatory syndrome and Muckle-Wells syndrome. Rilonacept works by blocking a certain natural protein in your body (interleukin-1) that may worsen the symptoms of CAPS. Rilonacept does not cure CAPS, but it can help lessen the symptoms, including rash, joint pain, fever, and tiredness.

Read the Patient Information Leaflet provided by your pharmacist before you start using rilonacept and each time you get a refill.

Inject this medication under the skin, usually once weekly or as directed by your doctor. Dosage is based on your age, weight, medical condition, and response to treatment.

If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. The mixed medication should be thick, clear, and colorless to pale yellow. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.

Before injecting each dose, clean the injection site with rubbing alcohol. It is important to change the location of the injection site each time to avoid problem areas under the skin. Do not inject into skin that is tender, red, or hard.

Use this medication regularly to get the most benefit from it. To help you remember, use it on the same day each week. It may help to mark your calendar with a reminder.

Tell your doctor if your condition does not improve or if it worsens.

Bruising, itching, pain, redness, swelling, or hardening of the skin at the injection site may occur. Injection site reactions usually go away after 1 or 2 days. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication can affect your immune system. It can lower your body's ability to fight an infection. You may be more likely to get serious infections, such as pneumonia, bone/joint infections, skin infections, or sinusitis. It may also be harder to fight an infection you already have. Tell your doctor promptly if you develop any signs of an infection, such as worsening redness/swelling/tenderness at the injection site after 2 days, fever/chills, or cold/flu symptoms. (See also Precautions section.) This medication can affect the amount of cholesterol and other fats (lipids) in your blood. Your doctor may periodically order laboratory tests to monitor this side effect and prescribe treatment if needed.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using rilonacept, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems (e.g., asthma), cancer, cuts or open sores, diabetes, immune system problems (e.g., HIV infection), current/recent/returning infection (including hepatitis and tuberculosis).

Rilonacept can make you more likely to get infections or may worsen any current infections. Therefore, do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose. Also avoid contact with people who have infections that may spread to others (e.g., chickenpox, flu). Wash your hands well to prevent the spread of infections.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Store the unmixed drug in the original container in the refrigerator between 36-46 degrees F (2-8 degrees C) away from light. After mixing, store at room temperature away from light. Use within 3 hours of mixing, and discard any unused portion. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: anti-cancer drugs, corticosteroids, live vaccines (e.g., polio vaccine taken by mouth, flu vaccine inhaled through the nose), drugs that block tumor necrosis factor-TNF (e.g., adalimumab, etanercept, infliximab), other drugs that block interleukin-1 (e.g., anakinra).

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

If you miss a dose, use it as soon as you remember if it is more than 24 hours before your next scheduled dose. If it is less than 24 hours before the next scheduled dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Do not share this medication with others.

Laboratory and/or medical tests (e.g., cholesterol, C-reactive protein, serum amyloid A) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.