RoActemra

RSS

tocilizumab

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

Overview

RoActemra 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 (with anti-inflammatory medicines called NSAIDs and corticosteroids) 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.

RoActemra is used in combination with methotrexate for these conditions but it can be used on its own in patients for whom methotrexate is inappropriate.

RoActemra 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 for the treatment of 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 RoActemra is used for CRS caused by medicines known as chimeric antigen receptors (CAR) T-cell medicines.

RoActemra 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).

RoActemra contains the active substance tocilizumab.

This EPAR was last updated on 04/04/2023

Authorisation details

Product details
Name
RoActemra
Agency product number
EMEA/H/C/000955
Active substance
tocilizumab
International non-proprietary name (INN) or common name
tocilizumab
Therapeutic area (MeSH)
  • Arthritis, Rheumatoid
  • Arthritis, Juvenile Rheumatoid
  • Cytokine Release Syndrome
  • Giant Cell Arteritis
  • COVID-19 virus infection
Anatomical therapeutic chemical (ATC) code
L04AC07
Publication details
Marketing-authorisation holder
Roche Registration GmbH
Revision
41
Date of issue of marketing authorisation valid throughout the European Union
15/01/2009
Contact address

Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany

Product information

21/03/2023 RoActemra - EMEA/H/C/000955 - N/0118

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

RoActemra, 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, RoActemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.
    RoActemra 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.


RoActemra 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. RoActemra can be given as monotherapy (in case of intolerance to MTX or where treatment with MTX is inappropriate) or in combination with MTX.

RoActemra 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.  RoActemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.

RoActemra is indicated for the treatment of Giant Cell Arteritis (GCA) in adult patients.

RoActemra, 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, RoActemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. 
    RoActemra 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.


RoActemra 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.

RoActemra is indicated for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 2 years of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids. RoActemra can be given as monotherapy (in case of intolerance to MTX or where treatment with MTX is inappropriate) or in combination with MTX.

RoActemra 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. RoActemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.

RoActemra 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.

RoActemra, 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, RoActemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. 
    RoActemra 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.


RoActemra 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.

RoActemra is indicated for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 2 years of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids. RoActemra can be given as monotherapy (in case of intolerance to MTX or where treatment with MTX is inappropriate) or in combination with MTX.

RoActemra 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. RoActemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.

RoActemra 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.

Assessment history

Changes since initial authorisation of medicine

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