Rilonacept, Injection ri-LON-fa-sept

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).

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 diseases such as HIV/AIDS or from cancer chemotherapy, radiation therapy, or steroid medicine
• 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 (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?

Check the label on the medicine for directions about your specific dose. Follow your healthcare provider's directions exactly.

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. Be sure you know how and when to have them and how much medicine to use. Use sterile, disposable syringes and needles. Use them only once and dispose of them safely, following your healthcare provider's instructions.

Read and follow the directions that come in the package of medicine for the shots. Carefully follow instructions for mixing this medicine. After mixing, check to make sure that the medicine is clear, and colorless to pale yellow. Make sure that there are no particles. Do not use the liquid if it is discolored or cloudy or if it contains particles.

Wash your hands before using this medicine. Follow these steps to give yourself the shots:

1. Choose a site on your abdomen around the belly button (but not within a 2-inch area around the belly button), thigh, upper arm, or other sites, as instructed by your healthcare provider. Each day, choose a different spot for the shot to lessen irritation.
2. Use an alcohol swab to clean the skin where you will give yourself the shot.
3. Gently pinch up the skin and insert the needle into the skin at a 45-to-90-degree angle, as instructed by your healthcare provider. After you insert the needle completely, release your grasp of the skin.
4. Gently pull back on the plunger of the syringe. If no blood appears, inject all of the solution by gently and steadily pushing down the plunger until the syringe is empty. If blood appears when you pull back on the plunger, withdraw the needle and syringe and gently press the alcohol swab on the injection site. Start over with a fresh needle.
5. After you have given yourself the shot, withdraw the needle and syringe and press the alcohol swab at the spot where the shot was given.
6. Discard the syringe, needle, and drug vial. Use the syringes and needles ONLY ONCE. Throw them away after use. Put used needles in rigid puncture-resistant containers with lids or caps, such as heavy plastic bleach bottles with screw caps. DO NOT throw needles directly into garbage cans or dumpsters.

If you are not sure of how to give yourself the shots, 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 virus 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)
• chemotherapy or medicines to treat cancer such as cyclophosphamide (Cytoxan, Neosar)
• corticosteroids such as betamethasone (Celestone), cortisone, dexamethasone, fludrocortisone (Florinef), hydrocortisone (Cortef), methylprednisolone (Medrol), prednisone (Sterapred), prednisolone (Orapred), and triamcinolone (Aristospan, Kenalog)
• etanercept (Enbrel)
• golimumab (Simponi)
• immunosuppressants such as cyclosporine (Gengraf, Sandimmune, Neoral), sirolimus (Rapamune), and tacrolimus (Prograf)
• natural remedies such as curcumin, echinacea, and green tea
• infliximab (Remicade)
• live virus vaccines
• 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.