Anakinra

Anakinra is currently being studied for the treatment of coronavirus disease 2019 (COVID-19) caused by the SARS-CoV-2 virus.

Clinical trial information is available at this time to support the use of anakinra for the treatment of COVID-19. More information is needed to know how well anakinra will work for the treatment of COVID-19 and the possible adverse events from it.

Anakinra has not undergone the standard review to be approved by the FDA for use. However, the FDA has approved an Emergency Use Authorization (EUA) to allow certain hospitalized adults who have COVID-19 with pneumonia who require supplemental oxygen and who are at risk of progression to severe COVID-19 to receive anakinra.

Anakinra is used to treat rheumatoid arthritis (condition in which the body attacks its own joints causing pain, swelling, and loss of function), neonatal-onset multisystem inflammatory disease (NOMID; a disorder that causes inflammation and damages the nervous system, skin, and joints), and deficiency of interleukin-1 receptor antagonist (DIRA; a disorder in which the body attacks its own tissues causing inflammation and damages bones, nervous system, skin, lungs, liver, and joints). Anakinra is authorized for the treatment of coronavirus disease 2019 (COVID-19 infection). Anakinra is in a class of medications called interleukin antagonists. It works by blocking the activity of interleukin, a substance in the body that causes inflammation.

Anakinra injection comes as a solution to inject subcutaneously (under the skin). It is given once or twice a day depending on the condition being treated.

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 caregiver how to inject it. You or the caregiver 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 do the injection.

Anakinra injection comes in prefilled glass syringes. 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. 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 (belly button) except for the 2-inch (5-centimeter) area around the navel. If someone else is giving you the injection, it can also 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.

For the treatment of COVID-19, it is given for 10 days.

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.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before using anakinra injection,

• tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while receiving anakinra injection.
• tell your doctor if you have or ever had kidney disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using anakinra, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are using anakinra.
• you should know that anakinra injection may decrease your ability to fight infection from bacteria, viruses, and fungi and increase the risk that you will get a serious infection. Tell your doctor if you often get any type of infection or if you have or think you may have any type of infection now. This includes minor infections (such as open cuts or sores), infections that come and go (such as herpes or cold sores), and chronic infections that do not go away. If you experience any of the following symptoms during or shortly after your treatment with anakinra injection, call your doctor immediately: fever, sweats, or chills; sore throat; cough; warm, red, or painful skin or sores on your body; frequent, urgent, or painful urination; or other signs of infection.
• you should know that using anakinra injection increases the risk that you will develop tuberculosis (TB; a serious lung infection), especially if you are already infected with tuberculosis but do not have any symptoms of the disease. Tell your doctor if you have or have ever had TB, if you have lived in a country where TB is common, or if you have been around someone who has TB. Your doctor will perform a skin test to see if you have an inactive TB infection. If necessary, your doctor will give you medication to treat this infection before you start using anakinra injection. If you have any of the following symptoms of TB, or if you develop any of these symptoms during your treatment, call your doctor immediately: cough, coughing up blood or mucus, weakness or tiredness, weight loss, loss of appetite, chills, fever, or night sweats.
• do not have any vaccinations without talking to your doctor.

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

Call your doctor if you forget to inject a dose of this medication. Your doctor will tell you when to inject the missed dose and when to inject your next scheduled dose. Do not use a double dose to make up for a missed one.

Anakinra may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• redness, swelling, bruising, itching, or pain at the site of injection
• headache
• nausea, vomiting, stomach pain, diarrhea
• runny nose
• joint pain

Some side effects can be serious. If you experience any of these symptoms or those listed in the SPECIAL PRECAUTIONS section, call your doctor immediately or get emergency medical treatment:

• rash, itching, hives; swelling of the lips, tongue, mouth, or face
• hard lump under the skin at the site of injection
• fever
• swollen glands
• dizziness, fainting,
• difficulty breathing, wheezing
• sweating
• fast or racing heartbeat

Anakinra may increase the risk of developing certain types of cancer including lymphoma (cancer that begins in the cells that fight infection) and skin cancer. People who have had severe rheumatoid arthritis for a long time may have a greater than normal risk of developing these cancers even if they do not use anakinra. Talk to your doctor about the risks of using this medication.

Anakinra may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

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.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

• Kineret^®