anakinra

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

The US Food and Drug Administration (FDA) has authorized emergency use of anakinra for the treatment of COVID-19 in hospitalized adults who tested positive for COVID-19 with pneumonia requiring supplemental oxygen, who are at risk of having severe respiratory failure, and are likely to have an increased risk of worsening of the disease (measured by abnormal blood levels of a certain protein).

What is anakinra?

The US Food and Drug Administration (FDA) has authorized emergency use of anakinra for the treatment of COVID-19 in hospitalized adults who tested positive for COVID-19 with pneumonia requiring supplemental oxygen, who are at risk of having severe respiratory failure, and are likely to have an increased risk of worsening of the disease (measured by abnormal blood levels of a certain protein).

Anakinra has not been approved to treat coronavirus or COVID-19.

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 can also be 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;
• tuberculosis; or
• if you are scheduled to receive a vaccine.

Tell your doctor if you are pregnant, plan to become pregnant, or breastfeeding.

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 before and 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;
• low white blood cell counts --mouth sores, skin sores, sore throat;
• signs of tuberculosis: fever, cough, night sweats, loss of appetite, weight loss, and feeling very tired.

Common side effects may include:

• abnormal liver function tests;
• rash;
• 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.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2023 Cerner Multum, Inc. Version: 7.01. Revision date: 11/10/2022.