Anakinra is used to treat rheumatoid arthritis. It helps to slow joint damage and reduces the joint pain/swelling so that you can move better. It is also used to treat a certain group of inherited disorders called cryopyrin-associated periodic syndromes (CAPS), including neonatal-onset multisystem inflammatory disease (NOMID). It helps to improve symptoms of NOMID such as fever, rash, joint pain, vomiting, and headache. Anakinra may also be used to treat another condition called Deficiency of Interleukin-1 Receptor Antagonist (DIRA), a condition where your body does not produce the natural protein interleukin-1 receptor antagonist.

Anakinra is a man-made form of a natural protein (interleukin-1 receptor antagonist) made by the body. It helps to block the effects of another protein (interleukin-1) which can cause symptoms such as joint pain/swelling/stiffness.

The FDA is allowing the emergency use of anakinra to treat coronavirus disease (COVID-19) in hospitalized patients with pneumonia and who also need supplemental oxygen. If anakinra is used to treat coronavirus disease, more information about the drug is available from the patient information sheet provided by your health care professional.

This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This drug may also be used for a certain type of rheumatoid arthritis in children (systemic juvenile idiopathic arthritis) or gout.

Read the Patient Information Leaflet and Instructions for Use if available from your pharmacist before you start using anakinra and each time you get a refill. Ask your health care professional how to prepare and use this medication. If you have any questions, consult your doctor or pharmacist.

Inject this medication under the skin as directed by your doctor, usually once a day. The injection is given in the upper arms, thighs, buttocks, or abdomen (except for a 2-inch area around your belly button). The dosage is based on your medical condition, weight, and response to treatment.

Take the medication out of the refrigerator 30 minutes before you inject it to allow it to reach room temperature. Do not shake the medication. Before using, check this product for particles or discoloration. If either is present, do not use the liquid. Before injecting each dose, clean the skin you are going to inject into (the injection site) with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Do not inject into skin that is tender, red, bruised, or hard or which has scars or stretch marks. To lessen bruising, do not rub the injection site after a shot. Learn how to store and discard medical supplies safely.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each day.

Tell your doctor if your condition does not get better or if it gets worse.

Redness, bruising, swelling, and pain at the injection site may occur. These skin reactions are usually mild and may last 2 to 4 weeks. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may lower your ability to fight infections. This may make you more likely to get a serious infection or make any infection you have worse. Get medical help right away if you have any signs of infection (such as sore throat that doesn't go away, fever, swollen lymph nodes, chills, cough).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using anakinra, tell your doctor or pharmacist if you are allergic to it; or to proteins made from a certain bacteria (E. coli); or to latex; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• current/past/returning infections (such as tuberculosis)
• immune system problems (such as HIV disease)
• kidney disease
• asthma

Anakinra can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

Tell your health care professional that you are using anakinra before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

Older adults may be at greater risk for infections while using this drug.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• abatacept
• TNF blockers (such as adalimumab, certolizumab, etanercept, infliximab)

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as absolute neutrophil count) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Store in the refrigerator away from light. Do not freeze. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.