Anakinra

IMPORTANT WARNING:

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

Only limited 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.

WHY is this medicine prescribed?

Anakinra is used alone or in combination with other medications to treat rheumatoid arthritis (condition in which the body attacks its own joints causing pain, swelling, and loss of function) in adults who were not helped by other disease-modifying antirheumatic drugs (DMARDs). Anakinra is also used to treat neonatal-onset multisystem inflammatory disease (NOMID; a disorder that causes inflammation and damages the nervous system, skin, and joints) in adults and children. Anakinra is also used to treat 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) in adults and children. Anakinra is authorized for the treatment of coronavirus disease 2019 (COVID-19 infection) in hospitalized adults who require supplemental oxygen, a ventilator, or who need extracorporeal membrane oxygenation (ECMO; a device that adds oxygen to the blood). 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.

Are there OTHER USES for this medicine?

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

HOW should this medicine be used?

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.

What SPECIAL PRECAUTIONS should I follow?

Before using anakinra injection,

• tell your doctor and pharmacist if you are allergic to anakinra, proteins made from bacterial cells (E. coli), latex, any other medications, or any of the ingredients in anakinra injection. Ask your doctor or pharmacist for a list of the ingredients.

• 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 asthma or 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.

• 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.

What SPECIAL DIETARY instructions should I follow?

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

What should I do IF I FORGET to take a dose?

Use the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not use a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

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
• diarrhea
• runny nose
• stomach pain
• 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
• dizziness
• fainting
• difficulty breathing
• wheezing
• sweating
• fast or racing heart beat

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 (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

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

What should I do in case of OVERDOSE?

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.

What OTHER INFORMATION should I know?

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.