Kineret (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. Kineret (Anakinra) inhibits joint damage by reducing erosions and cartilage destruction in people with active rheumatoid arthritis despite being treated with Methotrexate.

Kineret (Anakinra) is a copy of a protein that occurs naturally in our bodies, but it is made using bacterial cells. Kineret (Anakinra) 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.

Kineret (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.

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

Your doctor may have suggested Kineret (Anakinra) 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 Kineret (Anakinra), speak to your doctor. Do not stop using Kineret (Anakinra) without consulting your doctor.

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

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For the treatment of rheumatoid arthritis, the usual recommended dose of Kineret (Anakinra) is 100 mg per day. Kineret (Anakinra) 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 Kineret (Anakinra) is 1 mg to 2 mg per kg of body weight per day. Kineret (Anakinra) 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 Kineret (Anakinra) 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.

Kineret (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 Kineret (Anakinra) on your own until you fully understand how to do so.

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

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

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 Kineret (Anakinra). If you are concerned about side effects, discuss the risks and benefits of Kineret (Anakinra) with your doctor.

The following side effects have been reported by at least 1% of people taking Kineret (Anakinra). 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 Kineret (Anakinra).

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

Do not use Kineret (Anakinra) if you:

• are allergic to Kineret (Anakinra) or any ingredients of the medication
• are allergic to proteins made by the Escherichia coli bacteria

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There may be an interaction between Kineret (Anakinra) and any of the following:

• Abatacept
• adalimumab
• BCG
• Canakinumab
• certolizumab
• Denosumab
• echinacea
• etanercept
• Fingolimod
• Golimumab
• infliximab
• Leflunomide
• Natalizumab
• Nivolumab
• Pimecrolimus
• Pomalidomide
• Roflumilast
• sipuleucel-T
• Tacrolimus
• Tofacitinib
• Trastuzumab
• 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 Kineret (Anakinra). 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.

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 Kineret (Anakinra).

Allergic reactions: In rare cases, some people may develop a serious allergic reaction to Kineret (Anakinra). 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 Kineret (Anakinra). Speak to your doctor about the risks and benefits of using Kineret (Anakinra).

Blood problems: Rarely, people taking Kineret (Anakinra) 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 Kineret (Anakinra) for rheumatoid arthritis in clinical trials developed cancer of the immune system (known as lymphoma) more often than 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 Kineret (Anakinra). The role of Kineret (Anakinra) in developing cancer is not known.

Infections: There is an increased risk of serious infections in people who take Kineret (Anakinra). You should not take Kineret (Anakinra) if you have a serious infection. It is not known if Kineret (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 Kineret (Anakinra) to build up in the body, causing side effects. If you have decreased kidney function, discuss with your doctor how Kineret (Anakinra) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Kineret (Anakinra), and whether any special monitoring is needed.

Use with other biologics: Kineret (Anakinra) 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 Kineret (Anakinra).

Pregnancy: Kineret (Anakinra) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Kineret (Anakinra), contact your doctor immediately.

Breast-feeding: It is not known if Kineret (Anakinra) passes into breast milk. If you are a breast-feeding mother and are taking Kineret (Anakinra), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of Kineret (Anakinra) for treatment of rheumatoid arthritis have not been established for children less than 18 years of age. The safety and effectiveness of Kineret (Anakinra) 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 Kineret (Anakinra). Talk to your doctor about the risks and benefits of using Kineret (Anakinra).

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