Kineret (Anakinra)

Pronunciation: an-a-KIN-ra.

Generic name
anakinra
Drug class
Interleukin-1 receptor antagonist (IL-1Ra) biologic, produced in E. coli by recombinant DNA technology
Form
Solution for injection in a single-use prefilled syringe, 100 mg/0.67 mL (150 mg/mL)
Route
Subcutaneous injection
Legal status
Prescription-only biologic in every market confirmed this session (United States, United Kingdom, European Union, Canada, Australia); always check your own country and product label.

Availability and supply rules vary by country

Trade names by country: United States · United Kingdom · Canada · Australia

Australia: Kineret (5) · Full directory

What anakinra is and how it works

Kineret (anakinra) blocks the biological activity of interleukin-1 (IL-1), an inflammatory signalling protein, by competitively occupying the IL-1 receptor. It is given as a once-daily subcutaneous injection. (1) (3) (4)

Kineret's approved uses genuinely differ by country: Canada's current label covers rheumatoid arthritis and Neonatal-Onset Multisystem Inflammatory Disease (NOMID) only; the US label adds Deficiency of Interleukin-1 Receptor Antagonist (DIRA); the EU and Australian labels cover the widest range, including the full spectrum of Cryopyrin-Associated Periodic Syndromes, Still's disease, and (in the EU) COVID-19 and Familial Mediterranean Fever. Whatever the reason it is prescribed, the two most important safety facts to understand before starting are the increased risk of serious infections (which rises further if combined with a TNF-blocking medicine) and the risk of neutropenia (a drop in a type of white blood cell that fights infection), both of which require regular monitoring.

Mechanism of action: how anakinra works

Anakinra is a recombinant, non-glycosylated form of human interleukin-1 receptor antagonist (IL-1Ra), differing from native human IL-1Ra by an additional N-terminal methionine residue; it competitively blocks IL-1 binding to the interleukin-1 type I receptor (IL-1RI), which is expressed across a wide range of tissues. (5)

What anakinra is used for

Rheumatoid arthritis (RA)

Used to reduce the signs and symptoms of active rheumatoid arthritis in adults, typically alongside methotrexate, in patients who have not responded adequately to one or more disease-modifying antirheumatic drugs (DMARDs). (1) (2) (4)

Cryopyrin-Associated Periodic Syndromes (CAPS), including NOMID

Used to treat Neonatal-Onset Multisystem Inflammatory Disease (NOMID) in every market checked, and additionally Muckle-Wells Syndrome and Familial Cold Autoinflammatory Syndrome in the EU and Australia, in adults and paediatric patients aged 8 months and older weighing 10 kg or more. (1) (3) (5) (4)

Deficiency of Interleukin-1 Receptor Antagonist (DIRA)

Used to treat DIRA, a rare genetic autoinflammatory condition -- an indication confirmed on the US label reviewed for this dossier. (1)

Still's disease (EU and Australia)

Used to treat Still's disease, including Systemic Juvenile Idiopathic Arthritis (SJIA) and Adult-Onset Still's Disease (AOSD), confirmed on the EU and Australian labels reviewed for this dossier. (3) (5)

Familial Mediterranean Fever and COVID-19 (EU only)

The EU-centralised label additionally covers Familial Mediterranean Fever (given with colchicine if appropriate) and COVID-19 in adults with pneumonia requiring supplemental oxygen who are at risk of severe respiratory failure, based on a blood test (suPAR level) -- confirmed only on the EU label reviewed for this dossier, not on the US, UK, Canadian, or Australian labels checked. (3)

Before taking anakinra

Do not take / not appropriate for

  • Do not take if you have a known hypersensitivity to E. coli-derived proteins, to Kineret itself, or to any component of the product. (all countries) (1) (4)
  • Do not start Kineret if you already have neutropenia (a low neutrophil count, ANC below 1.5x10^9/L) -- this is a formal contraindication in the UK, EU, and Australia. (United Kingdom, European Union, Australia) (2) (5)
  • Combining Kineret with a TNF-blocking medicine (such as etanercept) is contraindicated in the UK, EU, and Australia, and not recommended in the US -- tell your prescriber about every other arthritis or biologic medicine you take. (all countries) (1) (5)
  • Do not start Kineret if you have an active infection, including a chronic or localised infection. (all countries) (1) (5)

Tell your clinician about

  • Any history of recurring infections, chronic infections, asthma, or conditions such as poorly controlled diabetes that may predispose you to infections.
  • Any history of tuberculosis or hepatitis B, or risk factors for either -- screening before starting is recommended.
  • If you have or have had cancer, since the use of Kineret in patients with pre-existing malignancy is not recommended.
  • If you have a history of asthma, which some evidence links to a higher serious-infection risk on Kineret.
  • If you are pregnant, planning pregnancy, or breastfeeding.
  • Any other medicines you take, especially other biologic or DMARD medicines.
  • Whether you are due to receive any vaccination -- live vaccines should not be given while taking Kineret.
(1) (2) (5)

How to take anakinra

  • Kineret is injected once daily under the skin (subcutaneously), at approximately the same time each day.
  • Each prefilled syringe is for single use in one patient on one occasion only -- discard any unused portion after each dose.
  • Rotate injection sites (for example, alternating areas of the abdomen, thigh, or upper arm) to reduce discomfort and the risk of injection-site amyloid deposits.
  • Allow the syringe to reach room temperature before injecting, and do not shake it.
  • NEVER stop, restart, or change your Kineret dose on your own -- always talk to your prescriber first, especially if you develop a new infection.
(1) (3)

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5) (6)

Missed dose

If you miss a dose, contact your prescriber or pharmacist for guidance rather than making up the missed dose yourself, and do not take a double dose.

Overdose

This dossier's sources did not detail specific overdose symptoms or management for Kineret. Seek urgent medical attention if an overdose is suspected rather than waiting to see if symptoms develop.

Side effects

Side effects and their urgency vary; report severe, persistent, or concerning symptoms.

Injection site reaction (redness, swelling, bruising, itching, or pain) -- reported in up to 71% of patients at the 100 mg daily dose.

What to notice: Injection site reaction (redness, swelling, bruising, itching, or pain) -- reported in up to 71% of patients at the 100 mg daily dose.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1) (2)

Headache.

What to notice: Headache.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1) (2)

Upper respiratory tract infections.

What to notice: Upper respiratory tract infections.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Nausea.

What to notice: Nausea.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Diarrhea.

What to notice: Diarrhea.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Increased blood cholesterol.

What to notice: Increased blood cholesterol.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (2)

Serious warnings

Signs of a serious infection — canada_serious_warnings_box; high caution elsewhere

Symptoms: Fever, chills, persistent cough, feeling very unwell, or a wound/area of skin that will not heal.

Action: Contact your prescriber promptly. Kineret should be discontinued if a serious infection develops. This risk is confirmed across every market checked (US 2% vs <1% placebo; UK/EU 1.8-1.9% vs 0.7%; Canada 1.7% vs 1.0%; Australia 1.8% vs 0.7%) and rises sharply (to around 7%) if Kineret is combined with a TNF-blocking medicine -- never combine these without your prescriber's explicit direction. Kineret should not be started if you have an active infection. (1) (2) (4) (5)

Neutropenia (low neutrophil/white blood cell count) — high caution

Symptoms: Often has no symptoms itself, which is why regular blood tests are required; may present as new or worsening infections.

Action: Your prescriber will check your neutrophil count before you start Kineret, then monthly for the first 3-6 months, then quarterly. Kineret should not be started if you are already neutropenic, and should be stopped if neutropenia develops -- this is a formal contraindication for starting treatment in the UK, EU, and Australia. (1) (2) (5)

Allergic reaction (including anaphylaxis and angioedema) — canada_serious_warnings_box; high caution elsewhere

Symptoms: Swelling of the face, lips, tongue, or throat; difficulty breathing; hives; severe rash.

Action: Seek emergency medical attention immediately for any of these symptoms. Kineret should be discontinued and appropriate therapy given if a severe allergic reaction occurs. (1) (2) (4)

Drug reaction with eosinophilia and systemic symptoms (DRESS) — high caution

Symptoms: Widespread rash, fever, swollen lymph nodes, and facial swelling -- a serious cutaneous reaction that may require hospitalisation and can be fatal.

Action: Seek prompt medical attention if these symptoms develop. This has been reported rarely, predominantly in patients with Systemic Juvenile Idiopathic Arthritis (SJIA). (1) (4) (5)

Macrophage Activation Syndrome (MAS) -- SJIA patients only — important safety information

Symptoms: Persistent high fever, easy bruising or bleeding, and feeling very unwell in a patient being treated for SJIA.

Action: Seek urgent medical attention. Patients with SJIA have an increased risk of spontaneous MAS; your prescriber will weigh the risk of MAS against the risk of infection flare if Kineret needs to be discontinued during a serious infection. (5)

Injection-site and systemic amyloidosis (NOMID/CINCA, high-dose/long-term use) — important safety information

Symptoms: Lumps or deposits at repeated injection sites; protein in the urine (proteinuria) in confirmed cases.

Action: Tell your prescriber about any unusual lumps at injection sites. Rotate injection sites to reduce this risk. Isolated cases of systemic amyloidosis have been reported in NOMID/CINCA patients on high, extended-duration doses; monitoring for proteinuria is recommended if injection-site deposits are confirmed. (1) (5)

Pulmonary events (interstitial lung disease, pulmonary hypertension) -- paediatric SJIA patients — important safety information

Symptoms: New or worsening shortness of breath or cough in a child being treated for SJIA.

Action: Seek medical advice promptly. These events have been reported postmarketing mainly in paediatric SJIA patients treated with IL-1 or IL-6 inhibitors including Kineret; patients with trisomy 21 appear overrepresented in reports. A causal relationship has not been established. (5)

Interactions

  • TNF-blocking medicines (such as etanercept): combination is contraindicated in the UK, EU, and Australia, and not recommended in the US, due to a substantially higher risk of serious infection and neutropenia without added clinical benefit. (1) (5)
  • Live vaccines should not be given while you are taking Kineret. (1) (2)
  • Tell your prescriber about all other medicines you take, especially other biologic or disease-modifying arthritis medicines, so they can check for interactions.

Pregnancy, breastfeeding, kidney/liver function, age

Pregnancy

This dossier's sources did not detail specific pregnancy safety data for Kineret -- discuss with your prescriber if you are pregnant or planning pregnancy. (1) (2) (3) (4) (5) (6)

Breastfeeding

This dossier's sources did not detail specific breastfeeding safety data for Kineret -- discuss with your prescriber if you are breastfeeding. (1) (2) (3) (4) (5) (6)

Children

Approved for CAPS/NOMID from 8 months of age and 10 kg body weight in every market checked; SJIA is approved from 2 years of age in Australia. RA use in children (Juvenile Idiopathic Arthritis) has not been established per the Canadian monograph reviewed. (1) (2) (3) (4) (5) (6)

Elderly

In pivotal controlled RA trials, 752 patients aged 65 or older were enrolled per the Canadian monograph reviewed, with no difference in safety or efficacy observed versus younger patients. (1) (2) (3) (4) (5) (6)

Hepatic_impairment

This dossier's sources did not detail specific hepatic dosing guidance for Kineret -- consult your prescriber. (1) (2) (3) (4) (5) (6)

Renal_impairment

Physicians may consider an alternate dose of 100 mg every other day for RA patients with severely reduced renal function, such as end-stage renal disease. (1) (2) (3) (4) (5) (6)

Monitoring

Before starting

  • Neutrophil count (absolute neutrophil count, ANC).
  • Screening for active infection, latent tuberculosis, and hepatitis B where risk factors are present.
  • Review for pre-existing malignancy.

During treatment

  • Neutrophil count monthly for the first 3-6 months, then quarterly for up to a year.
  • Watch for any new or worsening signs of infection and report them to your prescriber promptly.
  • Never stop, restart, or change your dose without talking to your prescriber first.
(1) (2)

Storage

Store refrigerated at 2-8°C, do not freeze, avoid shaking, and protect from light.

Professional information

Clinician-facing context only, sourced from the current US DailyMed prescribing information, UK EMC SmPC, EU EMA centrally-authorised SmPC, Health Canada product monograph, and Australia's TGA-approved PI reviewed for this dossier; verify against the current full label for the specific product before prescribing.

Canada

Indication: RA and NOMID only (narrowest indication set of the markets reviewed)

Dose summary: RA: 100 mg/day SC. NOMID: starting 1-2 mg/kg/day, maintenance 3-4 mg/kg/day, max 8 mg/kg/day.

Renal context: Alternate 100 mg every-other-day regimen may be considered for RA patients with severely reduced renal function (e.g. ESRD). (4)

European Union, Australia

Indication: Broadest indication set: RA, full CAPS spectrum, Still's disease (SJIA/AOSD), and (EU only) FMF and COVID-19

Dose summary: RA/CAPS dosing as above; COVID-19 (EU only): 100 mg/day SC for 10 days after suPAR-based selection; SJIA (Australia): 2 mg/kg/day up to a maximum of 100 mg/day.

Renal context: Sources reviewed for this dossier did not detail specific renal dosing guidance for these indications. (3) (5)

Mechanism of action

Hepatic guidance

Sources reviewed for this dossier did not detail specific hepatic dosing guidance.

Overdose note

Sources reviewed for this dossier did not detail specific overdose management guidance for Kineret. (5)

Frequently asked questions

Is Kineret available in the US, UK, EU, Canada, Australia, and New Zealand?

Confirmed authorised via direct regulator sources in the United States, United Kingdom, European Union (EMA-centralised authorisation), Canada, and Australia. New Zealand is disclosed as unable to verify -- a direct, repeated Medsafe search found no Kineret/anakinra-specific data sheet; anakinra is referenced only inside other, unrelated biologics' own NZ interaction-warning sections. (1) (2) (3) (4) (5) (6)

What is the most important safety risk to know about before starting Kineret?

Two: an increased risk of serious infections (which rises sharply if Kineret is combined with a TNF-blocking medicine such as etanercept, a combination that is contraindicated in several markets), and a risk of neutropenia (a drop in infection-fighting white blood cells), which is why regular blood tests are required before and during treatment. (1) (2) (5)

Is Kineret approved for the same conditions everywhere?

No. Canada's current label covers only rheumatoid arthritis and NOMID. The US label adds DIRA. The EU and Australian labels cover the widest range, including the full Cryopyrin-Associated Periodic Syndromes spectrum, Still's disease, and, in the EU only, COVID-19 and Familial Mediterranean Fever. (4) (1) (3) (5)

Does Kineret carry a boxed warning?

Not in the United States -- there is no boxed warning on the current US FDA label. Health Canada's product monograph, however, carries a formal 'Serious Warnings and Precautions Box' covering serious infections and anaphylactic reactions, which is Canada's own equivalent of a boxed warning. (1) (4)

What is the mechanism of action of anakinra?

Anakinra is a recombinant, non-glycosylated form of human interleukin-1 receptor antagonist (IL-1Ra), differing from native human IL-1Ra by an additional N-terminal methionine residue; it competitively blocks IL-1 binding to the interleukin-1 type I receptor (IL-1RI), which is expressed across a wide range of tissues. (5)

What is the generic name of Kineret (Anakinra)?

The generic name is anakinra. (1) (4)

What class of drug is anakinra?

Kineret (Anakinra) is classed as: Interleukin-1 receptor antagonist (IL-1Ra) biologic, produced in E. coli by recombinant DNA technology. (1) (4)

References

  1. KINERET (anakinra) injection, solution -- full prescribing informationDailyMed (U.S. National Library of Medicine) -- FDA-approved prescribing information · United States · dated 2025-01-01 · accessed 2026-07-31 · source 1
  2. Kineret 100 mg solution for injection in a pre-filled syringe -- SmPCelectronic medicines compendium (emc), United Kingdom -- Summary of Product Characteristics · United Kingdom · dated 2025-01-01 · accessed 2026-07-31 · source 2
  3. Kineret 100 mg/0.67 ml solution for injection in pre-filled syringe -- EPAR Product Information, Annex I SmPCEuropean Medicines Agency (EMA) -- centrally authorised EPAR Annex I Summary of Product Characteristics · European Union · dated 2025-01-01 · accessed 2026-07-31 · source 3
  4. KINERET (anakinra) Product Monograph, Submission Control No. 295209Health Canada -- Product Monograph (Drug Product Database) · Canada · dated 2025-08-29 · accessed 2026-07-31 · source 4
  5. KINERET anakinra 100 mg/0.67 mL solution for injection prefilled syringe (ARTG 82872) -- Australian Product Information vA16.0Therapeutic Goods Administration (TGA), Australia -- ARTG entry and approved Product Information · Australia · dated 2024-10-15 · accessed 2026-07-31 · source 5
  6. Direct Medsafe database and site search for anakinra/KineretMedsafe (New Zealand Medicines and Medical Devices Safety Authority) · New Zealand · accessed 2026-07-31 · source 6

Brand names by country

Single-ingredient anakinra names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries

United States

  • Kineret100 mg/.67mL · swedish orphan biovitrum ab (publ)

United Kingdom

  • Kineret (2)MHRA licensed via EU derived SmPC confirmed · 100 mg/0.67 mL prefilled syringe · Swedish Orphan Biovitrum Ltd

Canada

  • KINERET

Australia

  • Kineret (5)TGA ARTG registered confirmed 82872 · 100 mg/0.67 mL prefilled syringe · Swedish Orphan Biovitrum Pty Ltd
View brands in additional countries.

European Union

Kineret (3)