Kineret is a FDA approved medicine used to treat moderate to severe rheumatoid arthritis in adults, neonatal onset multisystem inflammatory disease (NOMID) in newborn babies, and deficiency of interleukin-1 receptor antagonist (DIRA) in adults and children.
Kineret also has emergency use authorization (EUA) for the treatment of COVID-19 in specific hospitalized patients.

Kineret works to reduce the body's immune response and inflammation by blocking the IL-1 receptor as it is an interleukin-1 (IL-1) receptor antagonist. 

Kineret is given as a subcutaneous injection daily or sometimes twice daily.

Kineret (anakinra) is used to control symptoms in: 

• Active rheumatoid arthritis that is moderate to severe, in adult patients who have tried disease modifying antirheumatic drugs (DMARDs) and they have not worked.
• Neonatal-onset multisystem inflammatory disease (NOMID) in new born babies. NOMID is a rare genetic condition that is a form of cryopyrin-associated periodic syndromes (CAPS). NOMID causes uncontrolled inflammation in many parts of the body, including the skin, joints, and central nervous system.
• 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.

• 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).

The US Food and Drug Administration (FDA) has authorized emergency use of Kineret 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).

You should not use Kineret if you are allergic to medicines that contain E. coli bacteria proteins, or if you have an active infection.

Before using Kineret, tell your doctor if you have asthma, kidney disease, a latex allergy, a weak immune system, an active or chronic infection, or signs of infection such as fever, chills, or open sores on your skin.

Kineret can lower blood cells that help your body fight infections. Your blood may need to be tested often. Avoid being near people who are sick or have infections. Stop using this medicine and call your doctor right away if you have signs of infection such as: fever, chills, flu symptoms, mouth sores, weight loss, or feeling tired or short of breath.

You may have a higher risk of infection if you are also using adalimumab (Humira), certolizumab (Cimzia), etanercept (Enbrel), golimumab (Simponi), infliximab (Remicade), adalimumab (Humira), cancer medicines, steroids, or medicines to prevent organ transplant rejection.

Do not give Kineret to anyone under 18 years old without medical advic

Use Kineret exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

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

Kineret 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 Kineret. 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 Kineret.

Anakinra affects your immune system. You may get infections more easily. You will need frequent medical tests before and while using Kineret 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.

Usual Adult Dose of Kineret for Rheumatoid Arthritis:

100 mg subcutaneously once daily at approximately the same time each day

Comments:
-Alternating the injection site is recommended to avoid discomfort at the site of injection.

Use: To reduce symptoms and slow the progression of structural damage in moderately to severely active rheumatoid arthritis (RA) in patients who have failed 1 or more disease modifying antirheumatic drugs (DMARDs)

Usual Adult Dose of Kineret for Interleukin-1 Receptor Antagonist Deficiency:

Initial dose: 1 to 2 mg/kg subcutaneously daily
Dose escalation: Adjust doses in 0.5 to 1 mg/kg increments
Maximum dose: 8 mg/kg subcutaneously daily

Use: For the treatment of Deficiency of Interleukin-1 Receptor Antagonist (DIRA)

Usual Pediatric Dose of Kineret for Cryopyrin-Associated Periodic Syndrome:

Initial dose: 1 to 2 mg/kg subcutaneously daily
Dose escalation: Adjust doses in 0.5 to 1 mg/kg increments
Maximum dose: 8 mg/kg subcutaneously daily
NOTE: Once daily administration is generally recommended, but the dose may be split into twice daily administrations.

Comments:
-The therapeutic response is primarily reflected by reduction in symptoms such as fever, rash, joint pain, and headache, but also in inflammatory serum markers (CRP/SAA levels), or occurrence of flares.

Use: Cryopyrin-Associated Periodic Syndromes (CAPS): Treatment of Neonatal-Onset Multisystem Inflammatory Disease (NOMID)

Usual Pediatric Dose of Kineret for Interleukin-1 Receptor Antagonist Deficiency:

1 month and older:
Initial dose: 1 to 2 mg/kg subcutaneously daily
Dose escalation: Adjust doses in 0.5 to 1 mg/kg increments
Maximum dose: 8 mg/kg subcutaneously daily

Use: For the treatment of Deficiency of Interleukin-1 Receptor Antagonist (DIRA) in children 1 month and older

Usual dose of Kineret for adults with COVID-19:

Recommended dosage of Kineret is 100 mg administered daily by subcutaneous injection for 10 days.

Dose for patients with severe renal insufficiency or end stage renal disease  (creatinine clearance < 30 mL/min, estimated from serum creatinine levels) consider a dose of 100 mg of Kineret administered every other day for 5 total doses over 10 days.

You should not use Kineret 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.

To make sure Kineret is safe for you, tell your doctor if you have:

• 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 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.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Do not give this medicine to a child without medical advice. Kineret 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.

Do not receive a "live" vaccine while using Kineret, 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 to Kineret: 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 Kineret for DIRA, you may have an increased risk of allergic reactions, especially in the first weeks of treatment.

Call your doctor at once if you have:

• fever or chills;

• low white blood cell counts - mouth sores, skin sores, sore throat; or

• signs of tuberculosis - fever, cough, night sweats, loss of appetite, weight loss, and feeling very tired.

Common Kineret 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.

You may have a higher risk of infection from Kineret 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 interact with anakinra, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.