Kineret contains the active substance anakinra. This is a type of cytokine (an immunosuppressant agent) that is used to treat:
- Rheumatoid arthritis (RA)
- COVID-19 disease in patients who have pneumonia, require supplemental oxygen and are at risk of lung failure
- Periodic febrile syndromes
- Cryopyrin-associated periodic syndromes (CAPS):
o Neonatal-onset multisystem inflammatory disease (NOMID)/chronic infantile neurologic-cutaneous-articular syndrome (CINCA)
Muckle-Wells Syndrome (MWS)
o Familial cold autoinflammatory syndrome (FCAS)
- Familial Mediterranean fever (FMF)
- Still's disease, including systemic juvenile idiopathic arthritis (SJIA) and adult-onset Still's disease (AOD)

Cytokines are proteins produced by your body that coordinate communication between cells and help control cell activity. In PAR, CAPS, FMF, Still's disease, and pneumonia associated with the disease
COVID-19, your body produces too much of a cytokine called interleukin-
1. It has harmful effects, leading to inflammation, causing the symptoms of the disease. Normally, your body produces a protein that blocks the harmful effects of interleukin-1.
The active substance in Kineret is anakinra, which works in the same way as the naturally occurring interleukin-1-blocking protein. Anakinra is produced by recombinant DNA technology using the microorganism E. coli.

In PAR, Kineret is used to treat the signs and symptoms of the disease in adult patients (aged 18 years and over) in combination with another medicine called methotrexate. Kineret is indicated for patients whose response to methotrexate alone is not sufficient to control rheumatoid arthritis.

In COVID-19, Kineret is used to treat hyperinflammation (more severe inflammation than usual) associated with the disease in adults (aged 18 years and over) who have pneumonia, need extra oxygen to help them breathe (low-flow or high-flow oxygen) and are at risk of lung failure.

For CAPS, Kineret is given to treat the signs and symptoms of inflammation associated with the disease, such as rash, joint pain, fever, headache and fatigue in adults and children (aged 8 months and over).

For FMF, Kineret is used to treat the signs and symptoms of inflammation associated with the disease, for example recurrent fever, fatigue, abdominal pain, muscle or joint pain and rash. Kineret can be used together with colchicine, if appropriate.

For Still's disease, Kineret is used to treat the signs and symptoms of inflammation associated with the disease, for example rash, joint pain and fever.

Do not use Kineret:
- if you are allergic to anakinra or any of the other ingredients of this medicine (listed in section 6).
drug.

Talk to your doctor before using Kineret.

Pregnancy and breastfeeding:
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor for advice before taking this medicine.

Kineret has not been tested in pregnant women. Kineret is not recommended for use during pregnancy, and in women of childbearing potential not using contraception. It is important to tell your doctor if you are pregnant, think you may be pregnant or are planning to become pregnant.
Your doctor will discuss with you the possible risks of taking Kineret during pregnancy.

It is not known whether anakinra is excreted in human milk. You should not breast-feed if you are using Kineret.

Kineret contains sodium and polysorbate 80
This medicine contains less than 1 mmol sodium (23 mg) per 100 mg dose, that is to say essentially “sodium-free”.

This medicine contains 0.70 mg of polysorbate 80 per pre-filled syringe, equivalent to 1.04 mg/ml. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

Always use this medicine exactly as your doctor has told you. Talk to your doctor or pharmacist if you are not sure. Kineret should be injected under the skin (subcutaneously) every day. You should try to give your injection at the same time each day.

The recommended dose is 20 to 90 mg or 100 mg. Your doctor will recommend the dose you need or if you need a dose higher than 100 mg.

COVID-19: the recommended dose is 100 mg, administered by injection under the skin (subcutaneous) daily for 10 days.

Self-injection with Kineret
Your doctor may decide that it is more convenient for you to inject Kineret yourself. Your doctor or nurse will show you how to inject yourself. Do not attempt to inject yourself unless you have been trained.

For instructions on how to self-inject or inject children with Kineret, read the “Instructions for preparing and injecting Kineret” section at the end of this leaflet.

- The active substance is anakinra. Each pre-filled graduated syringe contains 100 mg of anakinra.
- The other ingredients are: citric acid anhydrous, sodium chloride, disodium edetate dihydrate,
polysorbate 80 and sodium hydroxide and water for injections.

Warning:
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

7 pre-filled syringes