When This Medicine Should Not Be Used:
You should not use this medicine if you have had an allergic reaction to rilonacept.

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.

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

• Make sure your doctor knows if you are using medicines that weaken your immune system, such as a steroid or cancer treatment. Tell your doctor if you are using a blood thinner such as warfarin (Coumadin®).
• Do not take adalimumab (Humira®), anakinra (Kineret®), etanercept (Enbrel®), or infliximab (Remicade®) while you are being treated with this medicine, unless your doctor says it is okay.
• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines.

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have an immune system problem, diabetes, or asthma. Tell your doctor if you have any kind of infection, HIV or AIDS, hepatitis, tuberculosis (TB), or if you have been in close contact with someone who has TB.
• You will need to have a skin test for tuberculosis before you start using this medicine. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis test.
• Using this medicine may increase your risk of certain types of cancer. Talk with your doctor about this risk.
• You may get infections more easily while you are using this medicine. Avoid people who are sick or have infections. Call your doctor right away at the first signs of any infection (such as fever, chills, or cough).
• This medicine may cause a serious allergic reaction. Check with your doctor right away if you have a rash; itching; swelling of the face, tongue, and throat; trouble with breathing; or chest pain after you get the injection.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

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 or shortness of breath.
• Fever, chills, cough, hoarseness, runny or stuffy nose, sore throat, and body aches.
• Increase in how much or how often you urinate.
• Lower back or side pain, or painful urination.
• Pain or tenderness around eyes and cheekbones.
• Red, black, or bloody stools.
• Severe constipation, diarrhea, or stomach pain.
• Severe headache, stiff neck, or confusion.

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

• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings.
• 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