Kineret

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anakinra

Authorised
This medicine is authorised for use in the European Union.

Overview

Kineret is a medicine that is used to treat:

  • signs and symptoms of rheumatoid arthritis (an immune system disease causing inflammation of the joints) in adults. It is used in combination with methotrexate (a medicine used to reduce inflammation) in patients who have not responded adequately to methotrexate alone;
  • cryopyrin-associated periodic syndromes (CAPS). CAPS are an example of a group of recurring inflammatory conditions known as periodic fever syndromes. Patients with CAPS have an alteration in the gene that produces a protein called cryopyrin which makes it overactive and leads to inflammation in many parts of the body, with symptoms such as fever, rash, joint pain and tiredness. Severe disabilities such as deafness and loss of vision may also occur;
  • familial Mediterranean fever, another inherited periodic fever syndrome, which leads to repeated attacks of fever, inflammation and pain affecting various parts of the body including the abdomen (belly), joints, and chest. It may be associated with build-up of harmful protein deposits (amyloidosis) in organs such as the kidney. Kineret should be given with another medicine, colchicine, if appropriate;
  • Still’s disease, a disease causing inflammation of joints as well as rash and fever.

For CAPS, familial Mediterranean fever and Still’s disease, Kineret is used in patients from 8 months of age and weighing at least 10 kg.

Kineret contains the active substance anakinra.

This EPAR was last updated on 26/06/2020

Authorisation details

Product details
Name
Kineret
Agency product number
EMEA/H/C/000363
Active substance
anakinra
International non-proprietary name (INN) or common name
anakinra
Therapeutic area (MeSH)
Arthritis, Rheumatoid
Anatomical therapeutic chemical (ATC) code
L04AC03
Publication details
Marketing-authorisation holder
Swedish Orphan Biovitrum AB (publ)
Revision
27
Date of issue of marketing authorisation valid throughout the European Union
08/03/2002
Contact address

SE-112 76 Stockholm
Sweden

Product information

14/05/2020 Kineret - EMEA/H/C/000363 - II/0073

Contents

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Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

Rheumatoid Arthritis (RA)

Kineret is indicated in adults for the treatment of the signs and symptoms of RA in combination with methotrexate, with an inadequate response to methotrexate alone.

Periodic fever syndromes

Kineret is indicated for the treatment of the following autoinflammatory periodic fever syndromes in adults, adolescents, children and infants aged 8 months and older with a body weight of 10 kg or above:

Cryopyrin-Associated Periodic Syndromes (CAPS)

Kineret is indicated for the treatment of CAPS, including:

  • Neonatal-Onset Multisystem Inflammatory Disease (NOMID) / Chronic Infantile Neurological, Cutaneous, Articular Syndrome (CINCA)
  • Muckle-Wells Syndrome (MWS)
  • Familial Cold Autoinflammatory Syndrome (FCAS)

Familial Mediterranean Fever (FMF)

Kineret is indicated for the treatment of Familial Mediterranean Fever (FMF). Kineret should be given in combination with colchicine, if appropriate.

Still’s Disease

Kineret is indicated in adults, adolescents, children and infants aged 8 months and older with a body weight of 10 kg or above for the treatment of Still’s disease, including Systemic Juvenile Idiopathic Arthritis (SJIA) and Adult-Onset Still’s Disease (AOSD), with active systemic features of moderate to high disease activity, or in patients with continued disease activity after treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or glucocorticoids.

Kineret can be given as monotherapy or in combination with other anti-inflammatory drugs and disease-modifying antirheumatic drugs (DMARDs).

Assessment history

Changes since initial authorisation of medicine

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