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 in patients 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 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.

RoActemra can also be used in 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 chimeric antigen receptors (CAR) T-cell medicines.

RoActemra contains the active substance tocilizumab.

This EPAR was last updated on 05/12/2018

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
Anatomical therapeutic chemical (ATC) code
L04AC07
Publication details
Marketing-authorisation holder
Roche Registration GmbH
Revision
26
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

29/10/2018 RoActemra - EMEA/H/C/000955 - II/0076

Contents

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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 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 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.

Assessment history

Changes since initial authorisation of medicine

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