Rilonacept Solution for injection

What is this medicine?

RILONACEPT is used to treat familial cold autoinflammatory syndrome and Muckle-Wells syndrome. This medicine is not a cure.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

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

• diabetes

• hepatitis

• high cholesterol

• human immunodeficiency virus (HIV) infection

• immune system problems

• infection (especially a virus infection like chickenpox, cold sores, or herpes)

• lung or breathing disease, like asthma

• tuberculosis

• an unusual or allergic reaction to rilonacept, other medicines, hamster protein, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for injection under the skin. It is usually given by a health care professional in a hospital or clinic setting. If you get this medicine at home, you will be taught how to prepare and give it. Use exactly as directed. Take your medicine at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on your doctor's advice.

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 healthcare provider to get one.

Talk to your pediatrician regarding the use of this medicine in children. While this drug 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?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• adalimumab

• anakinra

• etanercept

• infliximab

This medicine may also interact with the following medications:

• steroid medicines like prednisone or cortisone

• vaccines

• 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 medicine?

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

Call your doctor or health care professional for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This medicine may increase your risk of getting an infection. Try to avoid being around people who are sick. Tell your doctor or health care professional if you are around anyone with measles or chickenpox or if you develop sores or blisters that do not heal properly.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• signs of infection - fever or chills, cough, sore throat, pain or difficulty passing urine

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

• redness, bruising, itching, stinging, or swelling at site where injected

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.

Where should I keep my medicine?

Keep out of reach of children.

If you are using this medicine at home, you will be instructed on how to store this medicine. Throw away any unused medicine after the expiration date on the label.