WARNINGS
Do not use KINERET if you are allergic to:
• proteins made from bacteria called E.Coli. Ask your healthcare provider if you are not sure.
• anakinra or any of the ingredients in KINERET. See the end of this leaflet for a complete list of ingredients in KINERET.
Before you use KINERET, tell your healthcare provider about all of your medical conditions, including if you:
• have an infection, a history of infections that keep coming back or other problems that can increase your risk of infections.
• are scheduled to receive any vaccines. People using KINERET should not receive live vaccines.
• have kidney problems.
• are pregnant or plan to become pregnant. It is not known if KINERET will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if KINERET passes into your breast milk. You and your healthcare provider should decide if you will use KINERET or breastfeed. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. KINERET and other medicines may affect each other and cause serious side effects. Especially, tell your healthcare provider if you take certain other medicines that:
• affect your immune system called Tumor Necrosis Factor (TNF) blockers Ask your healthcare provider for a list of these medicines if you are not sure. Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new prescription.
USES
What is KINERET?
KINERET is a prescription medicine called an interleukin-1 receptor antagonist (IL-1Ra) used to:
• Reduce the signs and symptoms and slow the damage of moderate to severe active rheumatoid arthritis (RA) in people age 18 years and older when 1 or more other medicines for RA have not worked.
• Treat people with a form of Cryopyrin-Associated Periodic Syndromes (CAPS) called Neonatal-Onset Multisystem Inflammatory Disease (NOMID).
• Treat people with Deficiency of Interleukin-1 Receptor Antagonist (DIRA). KINERET is not for children with Juvenile Rheumatoid Arthritis.
HOW TO USE
How should I use KINERET? • Read the Instructions for Use at the end of this Patient Information for information about the right way to use KINERET.
• Use KINERET exactly as your healthcare provider tells you to.
• You may not have to use all of the liquid medicine in the prefilled syringe. Your healthcare provider will show you how to find the correct dose of KINERET for you or your child.
• KINERET is given by injection under your skin.
• Inject KINERET at about the same time each day.
• If you have a kidney problem your healthcare provider may need to change how often you use your KINERET injections.
• If you miss a dose of KINERET, talk to your healthcare provider to find out when you should use your next injection.
What are the possible side effects of KINERET?
KINERET may cause serious side effects, including: • serious infections. KINERET may lower your ability to fight infections.
During your treatment with KINERET, call your healthcare provider right away if you:
o get an infection.
o have any sign of an infection including a fever or chills.
o have any open sores on your body. You may get an infection if you receive live vaccines while you use KINERET.
You should not receive live vaccines while you use KINERET.
• serious allergic reactions. Stop using KINERET, call your healthcare provider and, get emergency help right away if you have any of these symptoms of a serious allergic reaction:
o swelling of your face, lips, mouth or tongue o trouble breathing o wheezing
o severe itching
o skin rash, hives, redness, or swelling outside of the injection site area
o dizziness or fainting o fast heartbeat or pounding in your chest (tachycardia)
o sweating People with DIRA may have an increased risk of allergic reactions, especially in the first several weeks.
• decreased ability of your body to fight infections (immunosuppression). It is not known if treatment with medicines that cause immunosuppression, like KINERET, affect your risk of getting cancer.
• amyloidosis. Change (rotate) injection sites within the area you chose with each dose to reduce your risk of getting injection site amyloid deposits (a hard lump under the skin). If you develop amyloid deposits, your healthcare provider should monitor for symptoms and signs of systemic amyloidosis such as protein in urine.
o Do not use the exact same spot for each injection.
o Do not inject into abnormal skin (e.g., skin that is bruised, red, scaly, pitted, scarred, hard, thickened, lumpy, damaged, tender or a stretch mark).
• low white blood cell count (neutropenia). KINERET may cause you to have a lower number of certain white blood cells (neutrophils). Neutrophils are important in fighting infections. You should have blood tests before starting treatment with KINERET, then monthly for 3 months. After the first 3 months you should have your blood tested every 3 months for up to 1 year.
The most common side effects of KINERET include: • injection site skin reactions.
The symptoms of injection site skin reactions may include:
o redness
o itching
o swelling
o stinging
o bruising Most injection site reactions are mild, happen early during treatment, and last about 14 to 28 days. Injection site reactions have been observed less frequently in people with NOMID.
• rheumatoid arthritis (RA) gets worse even with treatment, if you already have RA
• headache
• nausea and vomiting
• diarrhea
• joint pain
• fever
• feeling like you have the flu
• sore throat or runny nose
• sinus infection
• pain in your stomach area
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of KINERET. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of KINERET. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use KINERET for a condition for which it was not prescribed. Do not give KINERET to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about KINERET that is written for health professionals.
What are the ingredients in KINERET?
Active ingredient: anakinra. Inactive ingredients: anhydrous citric acid, disodium EDTA, polysorbate 80, and sodium chloride in Water for Injection, USP.
OVERDOSE
Please call your healthcare provider for more information.
MISSED DOSE
If you miss a dose of KINERET, talk to your healthcare provider to find out when you should use your next injection.
STORAGE
How should I store KINERET?
Store KINERET in the refrigerator between 36-degrees F to 46-degrees F (2-degrees C to 8-degrees C).
Do not freeze or shake KINERET. Keep KINERET in its original carton and away from light. Keep KINERET and all medicines out of the reach of children.
NOTES
Medication Guide: revision date 09/2025
Prescribing Information: revision date 10/2025
No drug-drug interaction studies in human subjects have been conducted. Toxicologic and toxicokinetic studies in rats did not demonstrate any alterations in the clearance or toxicologic profile of either methotrexate or KINERET when the two agents were administered together.
TNF Blocking Agent:
A higher rate of serious infections has been observed in patients treated with concurrent KINERET and etanercept therapy than in patients treated with etanercept alone [see the sections WARNINGS and PRECAUTIONS above].
Two percent of patients treated concurrently with KINERET and etanercept developed neutropenia (ANC < 1 x 109/L). Use of KINERET in combination with TNF blocking agents is not recommended.
See the section WARNINGS above.
