Tyenne is a medicine used to treat:
- adults with severe rheumatoid arthritis that is getting worse, who have not been previously treated with a medicine called methotrexate;
- adults with moderate to severe active rheumatoid arthritis whose previous treatments with disease modifying antirheumatic drugs (DMARDs), such as methotrexate or medicines known as tumour necrosis factor (TNF) blockers, have not worked well enough or were not tolerated;
- children from 1 year of age with active systemic juvenile idiopathic arthritis in whom other treatments (anti-inflammatory medicines called NSAIDs and corticosteroids medicines by mouth or injection) have not worked well enough;
- children from 2 years of age with juvenile idiopathic polyarthritis in whom treatment with methotrexate has not worked well enough.
Tyenne is used in combination with methotrexate for these conditions but it can be used on its own in patients for whom methotrexate is inappropriate.
Tyenne is also used to treat:
- adults with giant cell arteritis, a disease in which arteries, usually of the head, are swollen;
- adults and children from 2 years of age with severe or life-threatening cytokine release syndrome (CRS, a condition that can cause nausea, vomiting, pain and low blood pressure). CRS is a side effect of certain cancer treatments and Tyenne is used for CRS caused by medicines known as chimeric antigen receptors (CAR) T-cell medicines.
Tyenne can also be used in adults with COVID-19 who are receiving treatment with corticosteroid medicines by mouth or injection and require extra oxygen or mechanical ventilation (breathing assisted by a machine).
Tyenne contains the active substance tocilizumab and is a ‘biosimilar medicine’. This means that Tyenne is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Tyenne is RoActemra. For more information on biosimilar medicines, see here.
Tyenne : EPAR - Medicine overview (PDF/113.24 KB)
First published: 02/10/2023
Tyenne : EPAR - Risk management plan summary (PDF/185.07 KB)
First published: 02/10/2023
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Fresenius Kabi Deutschland GmbH
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Tyenne - EMEA/H/C/005781 -
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Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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Tyenne, in combination with methotrexate (MTX), is indicated for
- the treatment of severe, active and progressive rheumatoid arthritis (RA) in adults not previously treated with MTX.
- the treatment of moderate to severe active RA in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists.
In these patients, Tyenne can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.
Tocilizumab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function when given in combination with methotrexate.
Tyenne is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation.
Tyenne is indicated for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 1 year of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids. Tyenne can be given as monotherapy (in case of intolerance to MTX or where treatment with MTX is inappropriate) or in combination with MTX.
Tyenne in combination with methotrexate (MTX) is indicated for the treatment of juvenile idiopathic polyarthritis (pJIA; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with MTX.
Tyenne can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.
Tyenne is indicated for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and paediatric patients 2 years of age and older.
Tyenne is indicated for the treatment of Giant Cell Arteritis (GCA) in adult patients.