Rilonacept (ril-ON-a-sept)

Treats recurrent pericarditis (RP) and cryopyrin-associated periodic syndromes (CAPS), including familial cold autoinflammatory syndrome (FCAS) and Muckle-Wells syndrome (MWS). Helps control symptoms of deficiency of interleukin-1 receptor antagonist (DIRA).

Brand Name(s):

Arcalyst

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• A nurse or other health provider will give you this medicine.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• Use a new needle and syringe each time you inject your medicine.
• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. Do not inject into skin areas that are bruised, red, tender, or hard.
• This powder medicine must be mixed with the liquid provided in your dose kit. Mix the medicine only when you are ready to use it. Do not use if it is cloudy or has specks floating in it.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• If you store this medicine at home, keep it in the refrigerator. Do not freeze.
• Once the powder medicine has been mixed with the liquid, this mixture may be stored at room temperature, away from direct light. You must use this mixture within 3 hours. Throw away any leftover mixture.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not take adalimumab, anakinra, etanercept, or infliximab while you are being treated with this medicine, unless your doctor says it is okay.
• Some medicines can affect how rilonacept works. Tell your doctor if you are using blood thinner (including warfarin) or medicine that weakens immune system (including steroid medicine).
• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have asthma, diabetes, a weak immune system, or any kind of infection, HIV or AIDS, hepatitis, or tuberculosis (TB).
• You will need to have a skin test for tuberculosis (TB) before you start using this medicine. Tell your doctor if you or anyone in your home has ever had a positive TB skin test or has been exposed to TB.
• This medicine may increase your risk of serious infections or cancer.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain
• Fever, chills, cough, hoarseness, runny or stuffy nose, sore throat, body aches
• Increase in how much or how often you urinate, lower back or side pain, painful urination
• Pain or tenderness around eyes and cheekbones
• Red, black, or bloody stools
• Severe headache, stiff neck, or confusion

If you notice these less serious side effects, talk with your doctor:

• Numbness, tingling, or burning pain in your hands, arms, legs, or feet
• Redness, pain, swelling, itching, blistering, or rash where the shot was given
• Upset stomach

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088