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.

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 injection comes as a solution to inject subcutaneously (under the skin). It is usually given once a day. However, when anakinra is given to treat neonatal-onset multisystem inflammatory disease, it may given once or twice daily. For the treatment of COVID-19, anakinra is given once a day for 10 days. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use anakinra injection exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

You will receive your first subcutaneous dose of anakinra injection in your doctor's office. After that, your doctor may decide that you or your caregiver can give the injections at home. Your doctor will show you or the person who will be giving the medication how to inject it. You or the person who will be injecting the medication should also read the written instructions for use that come with the medication. Be sure to ask your doctor or pharmacist if you have any questions about how to inject the medication.

Anakinra injection comes in prefilled glass syringes. There are 7 syringes in each box, one for each day of the week. Use each syringe only once. Even if there is still some solution left in the syringe after you inject, do not inject again. Dispose of used syringes in a puncture-resistant container. Talk to your doctor or pharmacist about how to dispose of the puncture-resistant container.

Remove the medication from the refrigerator 30 minutes before you are ready to inject the medication. Place it on a flat surface and allow it to reach room temperature. When removing the prefilled syringe from the box, do not shake the syringe or remove the cap covering the needle.

Check the prefilled syringe to be sure that the expiration date printed on the package has not passed. Look closely at the liquid in the syringe. The liquid should be clear and should not be cloudy or discolored or contain large particles. Call your pharmacist if there are any problems with the package or the syringe and do not inject the medication.

You may inject anakinra in the front of the middle thighs or in your lower stomach below your navel except for the 2-inch (5-centimeter) area around the navel. If someone else is giving you the injection, it can be injected into the outer area of your upper arms, or outer and upper areas of buttocks. Choose a different spot to inject the medication every day. Do not inject into an area where your skin is red, bruised, tender, hard, or scaly, or where you have scars or stretch marks. Do not inject close to a vein you can see under the skin.

Anakinra injection may help control your symptoms, but it will not cure your condition. Continue to use anakinra injection even if you feel well. Do not stop using anakinra injection without talking to your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

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.

Do not shake the prefilled syringe or you may ruin the medicine.

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.

Call your doctor if your arthritis symptoms do not improve, or if they get worse while using anakinra.

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.

Store in the refrigerator, do not freeze. Protect from light. Throw away any unused medicine after the expiration date on the label has passed.

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.

You should not use anakinra if you are allergic to anakinra or if you have:

• 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.

Call your doctor for instructions if you miss a dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep syringes and injection supplies out of the reach of children. Store anakinra syringes in the refrigerator. Do not freeze. Protect from light.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unless your doctor tells you otherwise, continue your normal diet.

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.

Get emergency medical help if you have signs of an allergic reaction: hives, sweating, severe itching; wheezing, difficult breathing; fast or pounding heartbeats; dizziness, fainting; swelling of your face, lips, tongue, or throat.

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

Anakinra may cause serious side effects. Call your doctor at once if you have:

• 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 of anakinra 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.

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.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests before and during treatment to check your body's response to anakinra.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.