Rilonacept, Injection

________________________________________________________________________

KEY POINTS

• This medicine is given by injection to treat Cryopyrin-Associated Periodic Syndromes.
• Keep all appointments for tests to see how this medicine affects you.
• You may get infections more easily when you are taking this medicine.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

________________________________________________________________________

What are other names for this medicine?

Type of medicine: interleukin-1 blocker

Generic and brand names: rilonacept, injection; Arcalyst

What is this medicine used for?

This medicine is given by injection (shots) to treat Cryopyrin-Associated Periodic Syndromes (CAPS).

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A weakened immune system from cancer treatment, diseases such as HIV/AIDS, or from taking steroid medicines or medicines to prevent organ transplant rejection
• Asthma
• Bleeding or bone marrow problems
• Diabetes
• High cholesterol or high triglycerides
• Liver problems such as hepatitis
• Problems with infections that keep coming back
• Tuberculosis

Tell your healthcare provider if you:

• Take immunosuppressants such as cyclosporine (Sandimmune, Neoral), sirolimus (Rapamune), tacrolimus (Prograf, Protopic), azathioprine (Imuran), mycophenolate mofetil (CellCept), and methotrexate (Otrexup, Rasuvo, Rheumatrex, Trexall)
• Have any kind of infection
• Are scheduled to have any kind of vaccination such as flu shots, pneumonia, polio, or measles vaccines

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

These shots are given just under the skin (subcutaneous) once a week. Sometimes you can give yourself these shots or have someone at home give them to you.

Check with your healthcare provider before using this in children under age 12.

Check the label on the medicine for directions about your specific dose. Be sure you know when to use the medicine and how much medicine you should use. Carefully follow the instructions for using this medicine. If you are not sure how to use this medicine, ask your healthcare provider or pharmacist for help.

What if I miss a dose?

If you miss a dose, inject it as soon as you remember, up to the day before your next dose. The next dose should be taken at the next regularly scheduled time. Do not use double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

Symptoms of an acute overdose have not been reported.

What should I watch out for?

Do not receive Live vaccines during treatment with this medicine. Talk with your healthcare provider about this.

You will need to have blood tests regularly to see how this medicine affects you. This medicine may increase the total cholesterol and triglyceride levels in your blood. Keep all appointments for tests.

You may get infections more easily when you are taking this medicine. Stay away from people with colds, flu, or other infections. Do not have any vaccines such as flu, pneumonia, or measles, without getting your healthcare provider's approval first. If you develop an unexplained fever, severe fatigue, muscle or joint pain, or unusual bruising or bleeding, contact your healthcare provider right away.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Chest pain; unexplained fever; severe fatigue; muscle or joint pain; unusual bruising or bleeding; trouble breathing; swollen glands; stomach pain; changes in the skin such as new sores, spots, lumps, or moles; sore throat; cough; yellowing of the skin or eyes; dark urine; light-colored bowel movements; ongoing vomiting or loss of appetite.

Other: Dizziness, headache, nausea, pain, redness, swelling, itching, bruising, bleeding, or warmth at the injection site.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Abatacept (Orencia)
• Adalimumab (Humira)
• Anakinra (Kineret)
• Canakinumab (Ilaris)
• Certolizumab (Cimzia)
• Corticosteroids such as betamethasone, cortisone, dexamethasone, fludrocortisone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), prednisolone (Omnipred, Orapred, Prelone), prednisone (Prednisone Intensol), and triamcinolone (Aristospan, Kenalog)
• Cyclophosphamide (Cytoxan)
• Etanercept (Enbrel)
• Golimumab (Simponi)
• Immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), and tacrolimus (Astagraf, Prograf, Protopic)
• Infliximab (Remicade)
• Live vaccines
• Natural remedies such as curcumin, echinacea, and green tea
• Thalidomide (Thalomid)
• Warfarin (Coumadin)

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine in the refrigerator inside the original carton. Do not freeze. Keep the container tightly closed. Protect it from heat, high humidity, and bright light. After you add the diluent to the medicine, you may keep the mixed solution at room temperature, protected from light, and use it within 3 hours after mixing it. Discard any unused portions of the medicine.

---

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.