Basic Information
Kevzara
Regulatory Information
EMEA/H/C/004254
June 23, 2017
April 21, 2017
15
March 28, 2025
Company Information
France
82 Avenue Raspail 94250 Gentilly
SANOFI WINTHROP INDUSTRIE
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Rheumatoid arthritis Kevzara in combination with methotrexate (MTX) is indicated for the treatment of moderately to severely active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (DMARDs). Kevzara can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate. Polymyalgia rheumatica Kevzara is indicated for the treatment of polymyalgia rheumatica (PMR) in adult patients who have had an inadequate response to corticosteroids or who experience a relapse during corticosteroid taper. Polyarticular juvenile idiopathic arthritis Kevzara is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (pJIA; rheumatoid factor positive or negative polyarthritis and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with conventional synthetic DMARDs (csDMARDs). Kevzara may be used as monotherapy or in combination with MTX.
Overview Summary
Kevzara is a medicine for treating: - adults with moderate to severe rheumatoid arthritis (a disease that causes inflammation of the joints) in whom treatment with one or more medicines known as disease-modifying anti-rheumatic drugs (DMARDs) has not worked well enough or has led to troublesome side effects. It is used with methotrexate (a DMARD) but can also be used alone if the patient cannot take methotrexate; - adults with polymyalgia rheumatica (an inflammatory disease that causes muscle pain and stiffness, especially in the shoulders and hips). It is used when corticosteroids are not working well enough or when the disease returned after reducing the corticosteroid dose; - children 2 years of age and older with active polyarticular juvenile idiopathic arthritis (a disease causing inflammation in the joints that starts in childhood) in whom DMARD treatment has not worked well enough. It is used alone or with methotrexate. Kevzara contains the active substance sarilumab.