anakinra

What is the most important information I should know about anakinra?

What is anakinra?

Anakinra is used to treat the symptoms of moderate to severe rheumatoid arthritis in adults. Anakinra may also help slow the progress of the disease. Anakinra is usually given after other arthritis medications did not work or have stopped working.

Anakinra is also used in newborn babies to treat a rare genetic condition called neonatal onset multisystem inflammatory disease (NOMID). NOMID is a form of cryopyrin-associated periodic syndromes (CAPS). This condition causes uncontrolled inflammation in many parts of the body, including the skin, joints, and central nervous system.

Anakinra is also used to control symptoms of a condition called Deficiency of Interleukin-1 Receptor Antagonist (DIRA) in adults and children. DIRA is a very rare genetic condition that causes a severe inflammatory reaction during the first days of life and can lead to organ failure throughout the body.

Anakinra may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before using anakinra?

• an active infection; or
• an allergy to any medicine that contains E. coli bacteria proteins.

Tell your doctor if you have ever had:

• kidney disease;
• an active or chronic infection;
• fever, chills, or open sores on your skin;
• a weak immune system (caused by disease or by using certain medicines):
• asthma; or
• tuberculosis.

Tell your doctor if you are pregnant or plan to become pregnant. Having rheumatoid arthritis or CAPS during pregnancy may increase the risk of premature birth or low birth weight. The benefit of treating rheumatoid arthritis or CAPS may outweigh any risks to the baby.

Do not give this medicine to a child without medical advice. Anakinra is not approved to treat rheumatoid arthritis in anyone younger than 18 years old.

How should I use anakinra?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Anakinra is injected under the skin. A healthcare provider may teach you how to properly use the medication by yourself.

Anakinra is given either once per day or once every other day. Follow your doctor's dosing instructions very carefully. Inject your dose at the same time of day when you use the medicine.

Your healthcare provider will show you where on your body to inject anakinra. Use a different place each time you give an injection. Each injection should be given at least 1 inch away from where you last injected the medicine.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand all instructions.

Prepare an injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.

Anakinra affects your immune system. You may get infections more easily. You will need frequent medical tests while using anakinra and for several months after you stop using it.

Each prefilled syringe is for one use only. Throw it away after one use, even if there is still medicine left inside.

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while using anakinra?

Do not receive a "live" vaccine while using anakinra, or you could develop an infection. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

What are the possible side effects of anakinra?

If you are using anakinra for DIRA, you may have an increased risk of allergic reactions, especially in the first weeks of treatment.

• fever or chills;
• open sores on your body; or
• signs of tuberculosis: fever, cough, night sweats, loss of appetite, weight loss, and feeling very tired.

Common side effects may include:

• worsening arthritis symptoms;
• nausea, vomiting, diarrhea, stomach pain;
• headache;
• joint pain;
• flu symptoms;
• cold symptoms such as stuffy nose, sneezing, sore throat; or
• redness, bruising, itching, stinging, or swelling where the injection was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect anakinra?

You may have a higher risk of infection from anakinra if you are also using:

• certolizumab;
• etanercept;
• golimumab;
• infliximab;
• adalimumab; or
• cancer medicines, steroids, or medicines to prevent organ transplant rejection.

This list is not complete. Other drugs may affect anakinra, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Where can I get more information?

Your pharmacist can provide more information about anakinra.