Pronunciation:

an-a-KIN-ra

Brand Names:

• Kineret

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Immunological Agent

Pharmacologic—

Interleukin-1 Inhibitor

Uses of This Medicine:

Anakinra injection is used alone or together with other medicines to treat signs and symptoms of moderately to severely active rheumatoid arthritis in patients who have previously received other medicines (eg, DMARDs) that did not work well.

Anakinra injection is also used to treat a rare genetic disorder called neonatal-onset multisystem inflammatory disease (NOMID). NOMID is the most severe form of a condition called cryopyrin-associated periodic syndrome (CAPS).

Anankira injection is also used to treat deficiency of interleukin-1 receptor antagonist (DIRA).

Anankira injection is also used to treat coronavirus disease 2019 (COVID-19) in patients with positive results of direct SARS-CoV-2 testing with pneumonia requiring supplemental oxygen, who are at high risk for progression to severe respiratory failure and likely to have a blood problem.

This medicine is available only with your doctor's prescription (for rheumatoid arthritis, NOMID, and DIRA) or given only by or under the immediate supervision of your doctor (for COVID-19).

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Use of anakinra injection is not recommended in children with juvenile rheumatoid arthritis and COVID-19.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of anakinra injection in the elderly. However, this medicine may cause serious infections and kidney problems more often in the elderly, which may require caution and an adjustment in the dose for patients receiving anakinra injection.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abatacept
• Adalimumab
• Anifrolumab-fnia
• Baricitinib
• Certolizumab Pegol
• Etanercept
• Golimumab
• Infliximab
• Rilonacept

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to E. coli-derived proteins or
• Infection, active—Should not be used in patients with these conditions.

• Cancer or
• Infection, chronic (long-term) or
• Weak immune system—It is not known if this medicine will worsen these conditions.

• Kidney disease—Higher blood levels of anakinra may result and your doctor may need to change your dose.

• Tuberculosis, inactive—May increase risk of this condition to become active again.

Proper Use of This Medicine:

COVID-19: A doctor or other trained health professional will give you this medicine. It is given as a shot under your skin for 10 days.

Rheumatoid arthritis, NOMID, and DIRA: This medicine is given as a shot under your skin. Anakinra may sometimes be given at home to patients who do not need to be in the hospital or clinic. If you are using this medicine at home, your doctor or nurse will teach you how to prepare and inject the medicine. Be sure that you understand how to use the medicine.

This medicine comes with a Patient Information, Instructions for Use leaflet, and Fact Sheet for Patients and Caregivers. Read and follow the instructions carefully. Ask your doctor if you have any questions.

If you use this medicine at home, you will be shown the body areas where this shot can be given. Use a different body area each time you give yourself or your child a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems.

Use a new needle, unopened prefilled syringe, or syringe each time you inject your medicine.

You might not use all of the medicine in each prefilled syringe. Use each syringe only one time. Do not save an open syringe. If the medicine in the syringe has changed color, or if you see particles in it, do not use it.

Use the medicine at the same time each day.

Throw the used needles away in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form (solution):
  • For rheumatoid arthritis:
    • Adults—100 milligrams (mg) per day injected under the skin.
    • Children—Use is not recommended.
  • For neonatal-onset multisystem inflammatory disease (NOMID) and deficiency interleukin-1 receptor antagonist (DIRA):
    • Adults and children—Dose is based on body weight and must be determined by your doctor. The starting dose is usually 1 to 2 milligrams (mg) per kilogram (kg) of body weight injected under the skin per day. Your doctor may increase your dose as needed. However, the dose is usually not more than 8 mg per kg of body weight per day.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store in the refrigerator. Do not freeze.

Do not shake the medicine. Protect it from light.

Precautions While Using This Medicine:

If you will be using this medicine for a long time, it is important that your doctor check the progress of you or your child at regular visits. This will allow your doctor to see if the medicine is working properly and to decide whether you should continue to use it. Blood tests may be needed to check for unwanted effects.

Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis skin test.

Your body's ability to fight infection may be reduced while you are being treated with anakinra, it is very important that you call your doctor at the first signs of any infection (for example, if you get a fever or chills).

Do not use this medicine together with adalimumab (Humira®), certolizumab pegol (Cimzia®), etanercept (Enbrel®), golimumab (Simponi®), or infliximab (Remicade®).

Anakinra may cause serious allergic reactions, including anaphylaxis or angioedema, which can be life-threatening and requires immediate medical attention. Check with your doctor right away if you or your child have a rash, itching, large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, trouble breathing, or chest pain after you receive the medicine.

This medicine may increase your risk of developing infections. Tell your doctor if you have any kind of infection before you start using this medicine. Also tell your doctor if you have ever had an infection that would not go away or an infection that kept coming back.

Do not have any live vaccines (immunizations) while you or your child are being treated with anakinra. Be sure to ask your child's doctor if you have any questions about this.

This medicine lowers the number of some types of blood cells in your body. Because of this, you may get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often.

This medicine may cause severe tenderness and pain at the site of the injection. Call your doctor right away if you have bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Agitation

coma

confusion

decreased urine output

diarrhea

dizziness

fast heartbeat

fever or chills

headache

itching, pain, redness, swelling, tenderness or warmth on the skin

irritability

joint pain

lethargy

muscle aches, pains, and twitching

nausea or vomiting

nervousness

numbness or tingling in the hands, feet, or lips

restlessness

runny nose or sneezing

seizures

sore throat

stomach pain

stupor

swelling of the face, ankles, or hands

swelling of the feet or lower legs

trouble breathing

unusual tiredness or weakness

weakness or heaviness of the legs

Less common

Black, tarry stools

cough

difficulty with swallowing

hives, itching, or rash

painful or difficult urination

pale skin

swelling of the face or lips

ulcers, sores, or white spots in the mouth

unusual bruising or bleeding

Incidence not known

Bleeding gums

blood in the urine or stools

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

pinpoint red spots on the skin

puffiness or swelling of the eyelids or around the eyes, face, lips or tongue

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

difficulty with moving

headache

muscle aches or stiffness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.