Anakinra

Anakinra may put your body at an increased risk for serious infections. This drug is not recommended if you have an infection or an infection-related illness (eg, pneumonia, tuberculosis). Tell your doctor if you have, or if you develop, any symptoms of an infection such as fever, persistent sore throat, productive cough (eg, sputum-producing), or unusual weakness. The risk of developing serious infections is even greater if you are also using a tumor necrosis factor medicine such as etanercept.

Reducing moderately to severely active rheumatoid arthritis in patients 18 years of age and older who have not successfully responded to other medicines. It may be used alone or with other medicines. It may also be used for other conditions as determined by your doctor.

Anakinra is an interleukin-1 (IL-1) blocker. It works by blocking the activity of interleukin-1 by binding to its receptor, which reduces inflammation and other signs and symptoms of arthritis.

• you are allergic to any ingredient in Anakinra
• you are allergic to proteins derived from Escherichia coli (E. coli)

Contact your doctor or health care provider right away if any of these apply to you.

Some medical conditions may interact with Anakinra . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have impaired kidney function
• if you have an infection that requires treatment with prescription antibiotics or is serious enough for you to be admitted to the hospital, or if you have an infection or develop an infection before undergoing therapy
• if you are planning to receive a live vaccine

Some MEDICINES MAY INTERACT with Anakinra . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Tumor necrosis factor-blocking agents (eg, adalimumab) because the risk of severe infection and/or low white blood cell counts may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Anakinra may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

Use Anakinra as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Anakinra comes with an additional patient leaflet. Read it carefully and reread it each time you get Anakinra refilled.
• Anakinra is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using Anakinra at home, carefully follow the injection procedures taught to you by your health care provider. Ask your doctor or other health care provider if you have any questions about how to administer Anakinra .
• Anakinra should be administered at the same time each day.
• Wash your hands thoroughly with soap and warm water before using Anakinra .
• Use a new syringe every day. Use the prefilled syringe only once. Throw away any unused portion of the medicine. Do not save for future use.
• If Anakinra contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
• Do not use a syringe that has been dropped or broken. Properly dispose of the damaged syringe and replace it with the syringe that would be used on the last day of the week in your current box. For example, if you start on Wednesday, the last day of the week in your series is Tuesday. After using all of the remaining syringes in your current box, start your next box.
• Do not use Anakinra beyond the expiration date on the container.
• Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.
• If you miss a dose of Anakinra , use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses on the same day.

Ask your health care provider any questions you may have about how to use Anakinra .

• If swelling or bruising at the injection site occurs, apply a cold pack on the injection site immediately after injection.
• Pain during or after injection can be lessened by using different injection locations, such as the stomach; by allowing the solution to warm to room temperature for 60 to 90 minutes before injecting; and by applying a cold pack on the injection site a few minutes before injection, and allowing the injection site to dry before injection.
• Improvement in rheumatoid arthritis symptoms usually occurs after 1 to 3 months of treatment with Anakinra .
• Anakinra may lower your body's ability to fight infection. Prevent infection by avoiding contact with people with colds or other infections. Notify your doctor of any signs of infection, including fever, sore throat, rash, or chills.
• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Anakinra .
• Avoid vaccinations with live virus vaccines (eg, measles, mumps, oral polio) while you are taking Anakinra . Check with your doctor before having any vaccinations while you are using Anakinra .
• LAB TESTS, including white blood cell counts, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• Anakinra is not recommended for use in CHILDREN. Safety and effectiveness have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Anakinra during pregnancy. It is unknown if Anakinra is excreted in breast milk. If you are or will be breast-feeding while you are using Anakinra , check with your doctor or pharmacist to discuss the risks to your baby.

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; flu-like symptoms; headache; nausea; reaction at the injection site (eg, redness, swelling, bruising, itching, pain, stinging); sinus inflammation; stomach pain; upper respiratory tract infection.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); cough; infection (fever, chills, sore throat); unexplained bone or joint pain.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects atIf OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control centeror emergency room immediately.

Store unopened syringes of Anakinra in the refrigerator, between 36 and 46 degrees F (2 to 8 degrees C). Store away from heat, moisture, and light. Do not shake or freeze. Do not use a syringe that has been left at room temperature for more than 24 hours. Do not use after the expiration date. Do not store in the bathroom. Keep Anakinra out of the reach of children and away from pets.

• If you have any questions about Anakinra , please talk with your doctor, pharmacist, or other health care provider.
• Anakinra is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Anakinra . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

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