Anakinra belongs to a group of medications called immunomodulatory agents. It is used alone or in combination with other medications to treat signs and symptoms of active rheumatoid arthritis in adults. Anakinra inhibits joint damage by reducing erosions and cartilage destruction for people who have active rheumatoid arthritis despite being treated with methotrexate.

Anakinra is a copy of a protein that occurs naturally in our bodies, but it is made using bacterial cells. This medication targets the immune system and decreases the action of interleukin-1, a protein that causes inflammation and tissue destruction in joints. It can take about 4 weeks of treatment for you to notice an improvement in symptoms.

Anakinra is also used to treat the signs and symptoms of inflammation associated with a rare genetic condition called Neonatal-Onset Multisystem Inflammatory Disease (NOMID), which is a form of Cryopyrin-Associated Periodic Syndromes (CAPS). This condition causes inflammation throughout the body and causes symptoms such as rash, joint pain, fever, and headache.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are being given this medication, speak to your doctor. Do not stop using this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to use this medication if their doctor has not prescribed it.

For the treatment of rheumatoid arthritis, the usual recommended dose of anakinra is 100 mg per day. This medication is given by subcutaneous (under the skin) injection, usually in the back of the upper arms, the abdomen, or the upper thigh. The injection should be given at about the same time each day, but the site of injection should be different each day.

For the treatment of NOMID, the dose for adults, adolescents, and children (aged 8 months or older with a body weight of 10 kg or more), the usual starting dose of anakinra is 1 mg to 2 mg per kg of body weight per day. This medication is given by subcutaneous (under the skin) injection. Your doctor may increase the dose depending on how well you respond to the medication. The usual maintenance dose is 3 mg to 4 mg per kg of body weight per day.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.

It is important to use this medication exactly as prescribed by your doctor. If you miss a dose, inject it as soon as you remember and contact your doctor. Do not double up on the dose the next day or inject a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Anakinra is used with the guidance and supervision of a doctor. Your doctor or nurse can show you how to give yourself the injections at home if you feel comfortable doing so. You will be given instructions on how to safely inject the medication and dispose of the used needle. A family member or caregiver can also learn how to give injections. Do not attempt to inject this medication on your own until you fully understand how to do so.

Store this medication in the refrigerator at 2°C to 8°C. It may be left at room temperature for up to 12 hours. Protect this medication from light, and keep it out of the reach of children. Do not shake this medication or allow it to freeze.

Each mL of injectable suspension contains 150 mg of anakinra. Nonmedicinal ingredients: disodium EDTA, polysorbate 80, sodium chloride, sodium citrate, and water for injection.

Do not use this medication if you:

• are allergic to anakinra or any ingredients of the medication
• are allergic to proteins made by the Escherichia coli bacteria

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• abdominal pain
• diarrhea
• headache
• nausea
• pain, redness, swelling, bruising, itching, or rash at the site of injection
• vomiting

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• flu-like symptoms
• joint pain
• signs of clotting problems (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don't stop bleeding)
• signs of a severe infection (e.g., fever, shaking or chills, fast heartbeat, quick breathing, confusion, skin rash)
• bone or joint infections
• cellulitis (an infection under the skin)
• pneumonia
• sinusitis
• upper respiratory tract infection (e.g., colds, sore throats, or sinus infections)
• worsening of rheumatoid arthritis symptoms

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of an allergic reaction (e.g., itching, rash, hives, swelling of face or lips, chest tightness, shortness of breath)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Allergic reactions: In rare cases, some people may develop a serious allergic reaction to this medication. Signs of an allergic reaction include a severe rash, swollen face, chest pain, or difficulty breathing. If these occur, contact your doctor immediately. The needle cover on the prefilled syringe contains dry natural rubber that is similar to latex. Before you start injections, tell your doctor if you have an allergy to rubber or latex.

Asthma: People with asthma may have a greater chance of developing serious infections while taking anakinra. Speak to your doctor about the risks and benefits of using this medication.

Blood problems: Rarely, people taking this medication have become deficient in certain types of blood cells. If you notice signs of an infection (fever, shaking or chills, fast heartbeat, or quick breathing) or bleeding (easy bruising, blood in the stools, black tarry stools, or vomiting blood or material that looks like coffee grounds), seek immediate medical attention.

Cancer: People taking anakinra for rheumatoid arthritis in clinical trials developed cancer of the immune system (known as lymphoma) more often compared to the general population. In general, people with severe rheumatoid arthritis who take medications that suppress the immune system over long periods of time have a higher risk of developing lymphoma, even if they don't take anakinra. The role of anakinra in developing cancer is not known.

Cholesterol: Anakinra may increase cholesterol levels. If you have high cholesterol, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Infections: People who take anakinra have an increased risk of serious infections. You should not take anakinra if you have a serious infection. It is not known if anakinra is safe for people with weak immune systems or chronic infections. If you notice signs of an infection such as fever, chills, pain, swelling, or pus, contact your doctor as soon as possible.

Kidney problems: Kidney disease or reduced kidney function may cause this medication to build up in the body, causing side effects. If you have decreased kidney function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Use with other biologics: This medication should not be used at the same time with a class of medications called biologic response modifiers ("biologics") or TNF blockers (e.g., adalimumab, etanercept, infliximab). Doing so could increase the risk of infections.

Vaccines: Live vaccines should not be given during treatment with anakinra.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if anakinra passes into breast milk. If you are breast-feeding and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of this medication for treatment of rheumatoid arthritis have not been established for children less than 18 years of age. The safety and effectiveness of this medication for the treatment of NOMID have not been established for children less than 8 months of age.

Seniors: Seniors may be more likely to experience serious infections with anakinra. Talk to your doctor about the risks and benefits of using this medication.

There may be an interaction between anakinra and any of the following:

• abatacept
• adalimumab
• BCG
• baricitinib
• canakinumab
• certolizumab
• cladribine
• denosumab
• echinacea
• etanercept
• fingolimod
• golimumab
• infliximab
• leflunomide
• natalizumab
• nivolumab
• ocrelizumab
• ofatumumab
• ozanimod
• pimecrolimus
• pomalidomide
• ponesimod
• rituximab
• roflumilast
• sarilumab
• siponimod
• sipuleucel-T
• tacrolimus
• tocilizumab
• tofacitinib
• trastuzumab
• upadacitinib
• vaccines

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.