RoActemra

tocilizumab

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This is a summary of the European Public Assessment Report (EPAR) for RoActemra. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use RoActemra.

For practical information about using RoActemra, patients should read the package leaflet or contact their doctor or pharmacist.

What is RoActemra and what is it used for?

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 2 years 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 contains the active substance tocilizumab.

How is RoActemra used?

RoActemra is available as solution to be injected under the skin and as a concentrate for making a solution for infusion (drip) into a vein. How RoActemra is given, its dose and how often it is given depends on the condition it is used to treat. For more information, see the package leaflet.

RoActemra can only be obtained with a prescription and treatment for any conditions should be started by a doctor who has experience in the diagnosis and treatment of that condition.

How does RoActemra work?

The active substance in RoActemra, tocilizumab, is a monoclonal antibody. A monoclonal antibody is a type of protein that has been designed to recognise and attach to a specific target (called an antigen) in the body. Tocilizumab attaches to the receptor for a messenger molecule or ‘cytokine’ in the body called interleukin‑6. This messenger is involved with inflammation and is found at high levels in patients with rheumatoid arthritis, systemic juvenile idiopathic arthritis, juvenile idiopathic polyarthritis and giant cell arteritis. By preventing interleukin‑6 attaching to its receptors, tocilizumab reduces the inflammation and other symptoms of these diseases.

What benefits of RoActemra have been shown in studies?

Rheumatoid arthritis

In severe rheumatoid arthritis not previously treated with methotrexate, RoActemra given by infusion was investigated in one main study involving 1,162 patients. RoActemra, on its own or in combination with methotrexate, was compared with placebo (a dummy treatment) plus methotrexate. After 6 months of treatment, 45% of patients taking RoActemra in combination with methotrexate (130 out of 290) and 39% of patients taking RoActemra on its own (113 out of 292) achieved remission (did not show symptoms of the disease), compared with 15% of those taking placebo plus methotrexate (43 out of 287).

For the treatment of moderate to severe rheumatoid arthritis where other medicines were unsuccessful, RoActemra given by infusion was studied in five main studies involving a total of over 4,000 adults. In three of these studies, RoActemra was compared with placebo, as an add-on to failing treatment with conventional rheumatoid arthritis medicines in a total of over 3,000 patients. Results showed that patients adding RoActemra were around 4 times more likely to respond to treatment than those adding placebo. One of the studies, which involved 1,196 patients, also showed that the combination of RoActemra and methotrexate slowed down the damage to the joints and improved physical function after up to 2 years, when compared with the combination of placebo and methotrexate. In the fourth study, which included 498 patients who had an inadequate response to TNF blockers, patients receiving RoActemra with methotrexate were around 9 times more likely to respond than those receiving placebo with methotrexate. The fifth study involving 673 patients showed that patients receiving RoActemra on its own were more likely to respond than those taking methotrexate on its own. Almost 4,000 patients from these 5 studies went on to enter studies looking at the long-term effects of RoActemra treatment and results showed that response to RoActemra is maintained for at least 2 years.

RoActemra given by injection under the skin was investigated in two studies involving 1,918 patients with moderate to severe rheumatoid arthritis where previous treatment with DMARD had not worked well. In the first study, RoActemra was more effective than placebo in treating rheumatoid arthritis: after 6 months of treatment with RoActemra, 61% of patients responded to treatment compared with 32% on placebo. The other study, which compared RoActemra injected under the skin with RoActemra given by infusion, showed that RoActemra injected under the skin was no less effective in achieving a response after 6 months.

Juvenile idiopathic arthritis

In systemic juvenile idiopathic arthritis, RoActemra given by infusion was compared with placebo in one main study involving 112 children in whom treatment with NSAID and corticosteroids did not work well enough. In this study 85% (64 out of 75) patients treated with RoActemra responded to treatment and no longer had fever after 3 months, compared with 24% (9 out of 37) patients receiving placebo.

Juvenile idiopathic polyarthritis

In juvenile idiopathic polyarthritis, RoActemra given by infusion was compared with placebo in one main study involving 166 children from 2 years of age who could not take methotrexate or it did not work well enough. Patients were allowed to continue treatment with methotrexate during the study. After 4 to 6 months of treatment, 26% of patients on RoActemra (21 out of 82) had a flare-up of symptoms during treatment, compared with 48% of patients taking placebo (39 out of 81).

Giant cell arteritis

In giant cell arteritis, RoActemra given by injection under the skin was found more effective than placebo in one main study involving 251 adults. All patients were also treated with a corticosteroid, which was stopped after reducing the dose gradually over 6 or 12 months. One year after starting treatment, 56% of patients treated with RoActemra once a week did not have symptoms compared with 14% patients receiving placebo.

What are the risks associated with RoActemra?

The most common side effects (occurring in up to 1 patient in 10) with RoActemra are upper respiratory tract infections (nose and throat infection), nasopharyngitis (inflammation of the nose and throat), headache, hypertension (high blood pressure) and abnormal liver function tests. The most serious side effects are serious infections, complications of diverticulitis (a disease affecting the gut) and hypersensitivity (allergic) reactions. For the full list of all side effects reported with RoActemra, see the package leaflet.

RoActemra must not be used in patients who have an active, severe infection. Doctors should monitor patients carefully for signs of infection during treatment, and should prescribe RoActemra with caution in patients who have had recurring or long-term infections, or diseases that could increase the risk of infections, such as diverticulitis or diabetes. For the full list of restrictions, see the package leaflet.

Why is RoActemra approved?

Studies show RoActemra is effective at reducing symptoms of several inflammatory conditions. The European Medicines Agency decided that RoActemra’s benefits are greater than its risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of RoActemra?

The company that makes RoActemra must supply all doctors expected to prescribe the medicine with an educational pack containing important information on the safety and correct use of RoActemra. The pack will also include a patient alert card with key safety information for patients.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of RoActemra have also been included in the summary of product characteristics and the package leaflet.

Other information about RoActemra:

The European Commission granted a marketing authorisation valid throughout the European Union for RoActemra on 16 January 2009.

For more information about treatment with RoActemra, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
RoActemra : EPAR - Summary for the public BG = bălgarski 2009-02-18 2017-09-29
RoActemra : EPAR - Summary for the public ES = español 2009-02-18 2017-09-29
RoActemra : EPAR - Summary for the public CS = čeština 2009-02-18 2017-09-29
RoActemra : EPAR - Summary for the public DA = dansk 2009-02-18 2017-09-29
RoActemra : EPAR - Summary for the public DE = Deutsch 2009-02-18 2017-09-29
RoActemra : EPAR - Summary for the public ET = eesti keel 2009-02-18 2017-09-29
RoActemra : EPAR - Summary for the public EL = elliniká 2009-02-18 2017-09-29
RoActemra : EPAR - Summary for the public EN = English 2009-02-18 2017-09-29
RoActemra : EPAR - Summary for the public FR = français 2009-02-18 2017-09-29
RoActemra : EPAR - Summary for the public IT = italiano 2009-02-18 2017-09-29
RoActemra : EPAR - Summary for the public LV = latviešu valoda 2009-02-18 2017-09-29
RoActemra : EPAR - Summary for the public LT = lietuvių kalba 2009-02-18 2017-09-29
RoActemra : EPAR - Summary for the public HU = magyar 2009-02-18 2017-09-29
RoActemra : EPAR - Summary for the public MT = Malti 2009-02-18 2017-09-29
RoActemra : EPAR - Summary for the public NL = Nederlands 2009-02-18 2017-09-29
RoActemra : EPAR - Summary for the public PL = polski 2009-02-18 2017-09-29
RoActemra : EPAR - Summary for the public PT = português 2009-02-18 2017-09-29
RoActemra : EPAR - Summary for the public RO = română 2009-02-18 2017-09-29
RoActemra : EPAR - Summary for the public SK = slovenčina 2009-02-18 2017-09-29
RoActemra : EPAR - Summary for the public SL = slovenščina 2009-02-18 2017-09-29
RoActemra : EPAR - Summary for the public FI = suomi 2009-02-18 2017-09-29
RoActemra : EPAR - Summary for the public SV = svenska 2009-02-18 2017-09-29
RoActemra : EPAR - Summary for the public HR = Hrvatski 2009-02-18 2017-09-29

This EPAR was last updated on 29/09/2017 .

Authorisation details

Product details

Product details for RoActemra
NameRoActemra
Agency product numberEMEA/H/C/000955
Active substance

tocilizumab

International non-proprietary name (INN) or common name

tocilizumab

Therapeutic area Arthritis, RheumatoidArthritis, Juvenile Rheumatoid
Anatomical therapeutic chemical (ATC) code L04AC07

Publication details

Publication details for RoActemra
Marketing-authorisation holder

Roche Registration Limited

Revision22
Date of issue of marketing authorisation valid throughout the European Union16/01/2009

Contact address:

Roche Registration Limited
6 Falcon Way
Shire Park
Welwyn
Garden City AL7 1TW
United Kingdom

Product information

Product information

18/09/2017  RoActemra -EMEA/H/C/000955 -II/0066

Name Language First published Last updated
RoActemra : EPAR - Product Information HR = Hrvatski 2010-01-08 2017-09-29
RoActemra : EPAR - Product Information HR = Hrvatski 2010-01-08 2017-09-29
RoActemra : EPAR - Product Information HR = Hrvatski 2010-01-08 2017-09-29
RoActemra : EPAR - Product Information HR = Hrvatski 2010-01-08 2017-09-29
RoActemra : EPAR - Product Information HR = Hrvatski 2010-01-08 2017-09-29
RoActemra : EPAR - Product Information HR = Hrvatski 2010-01-08 2017-09-29
RoActemra : EPAR - Product Information HR = Hrvatski 2010-01-08 2017-09-29
RoActemra : EPAR - Product Information HR = Hrvatski 2010-01-08 2017-09-29
RoActemra : EPAR - Product Information HR = Hrvatski 2010-01-08 2017-09-29
RoActemra : EPAR - Product Information HR = Hrvatski 2010-01-08 2017-09-29
RoActemra : EPAR - Product Information HR = Hrvatski 2010-01-08 2017-09-29
RoActemra : EPAR - Product Information HR = Hrvatski 2010-01-08 2017-09-29
RoActemra : EPAR - Product Information HR = Hrvatski 2010-01-08 2017-09-29
RoActemra : EPAR - Product Information HR = Hrvatski 2010-01-08 2017-09-29
RoActemra : EPAR - Product Information HR = Hrvatski 2010-01-08 2017-09-29
RoActemra : EPAR - Product Information HR = Hrvatski 2010-01-08 2017-09-29
RoActemra : EPAR - Product Information HR = Hrvatski 2010-01-08 2017-09-29
RoActemra : EPAR - Product Information HR = Hrvatski 2010-01-08 2017-09-29
RoActemra : EPAR - Product Information HR = Hrvatski 2010-01-08 2017-09-29
RoActemra : EPAR - Product Information HR = Hrvatski 2010-01-08 2017-09-29
RoActemra : EPAR - Product Information HR = Hrvatski 2010-01-08 2017-09-29
RoActemra : EPAR - Product Information HR = Hrvatski 2010-01-08 2017-09-29
RoActemra : EPAR - Product Information HR = Hrvatski 2010-01-08 2017-09-29
RoActemra : EPAR - Product Information HR = Hrvatski 2010-01-08 2017-09-29
RoActemra : EPAR - Product Information HR = Hrvatski 2010-01-08 2017-09-29

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
RoActemra : EPAR - All Authorised presentations HR = Hrvatski 2009-02-18 2015-01-20
RoActemra : EPAR - All Authorised presentations HR = Hrvatski 2009-02-18 2015-01-20
RoActemra : EPAR - All Authorised presentations HR = Hrvatski 2009-02-18 2015-01-20
RoActemra : EPAR - All Authorised presentations HR = Hrvatski 2009-02-18 2015-01-20
RoActemra : EPAR - All Authorised presentations HR = Hrvatski 2009-02-18 2015-01-20
RoActemra : EPAR - All Authorised presentations HR = Hrvatski 2009-02-18 2015-01-20
RoActemra : EPAR - All Authorised presentations HR = Hrvatski 2009-02-18 2015-01-20
RoActemra : EPAR - All Authorised presentations HR = Hrvatski 2009-02-18 2015-01-20
RoActemra : EPAR - All Authorised presentations HR = Hrvatski 2009-02-18 2015-01-20
RoActemra : EPAR - All Authorised presentations HR = Hrvatski 2009-02-18 2015-01-20
RoActemra : EPAR - All Authorised presentations HR = Hrvatski 2009-02-18 2015-01-20
RoActemra : EPAR - All Authorised presentations HR = Hrvatski 2009-02-18 2015-01-20
RoActemra : EPAR - All Authorised presentations HR = Hrvatski 2009-02-18 2015-01-20
RoActemra : EPAR - All Authorised presentations HR = Hrvatski 2009-02-18 2015-01-20
RoActemra : EPAR - All Authorised presentations HR = Hrvatski 2009-02-18 2015-01-20
RoActemra : EPAR - All Authorised presentations HR = Hrvatski 2009-02-18 2015-01-20
RoActemra : EPAR - All Authorised presentations HR = Hrvatski 2009-02-18 2015-01-20
RoActemra : EPAR - All Authorised presentations HR = Hrvatski 2009-02-18 2015-01-20
RoActemra : EPAR - All Authorised presentations HR = Hrvatski 2009-02-18 2015-01-20
RoActemra : EPAR - All Authorised presentations HR = Hrvatski 2009-02-18 2015-01-20
RoActemra : EPAR - All Authorised presentations HR = Hrvatski 2009-02-18 2015-01-20
RoActemra : EPAR - All Authorised presentations HR = Hrvatski 2009-02-18 2015-01-20
RoActemra : EPAR - All Authorised presentations HR = Hrvatski 2009-02-18 2015-01-20
RoActemra : EPAR - All Authorised presentations HR = Hrvatski 2009-02-18 2015-01-20
RoActemra : EPAR - All Authorised presentations HR = Hrvatski 2009-02-18 2015-01-20

Name Language First published Last updated
RoActemra : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-02-18 2011-08-30
RoActemra : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-02-18 2011-08-30
RoActemra : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-02-18 2011-08-30
RoActemra : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-02-18 2011-08-30
RoActemra : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-02-18 2011-08-30
RoActemra : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-02-18 2011-08-30
RoActemra : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-02-18 2011-08-30
RoActemra : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-02-18 2011-08-30
RoActemra : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-02-18 2011-08-30
RoActemra : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-02-18 2011-08-30
RoActemra : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-02-18 2011-08-30
RoActemra : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-02-18 2011-08-30
RoActemra : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-02-18 2011-08-30
RoActemra : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-02-18 2011-08-30
RoActemra : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-02-18 2011-08-30
RoActemra : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-02-18 2011-08-30
RoActemra : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-02-18 2011-08-30
RoActemra : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-02-18 2011-08-30
RoActemra : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-02-18 2011-08-30
RoActemra : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-02-18 2011-08-30
RoActemra : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-02-18 2011-08-30
RoActemra : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-02-18 2011-08-30
RoActemra : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-02-18 2011-08-30
RoActemra : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-02-18 2011-08-30

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

Initial marketing-authorisation documents

Name Language First published Last updated
RoActemra : EPAR - Public assessment report HR = Hrvatski 2009-02-18  
Committee for medicinal products for human use, summary of positive opinion for RoActemra HR = Hrvatski 2008-11-20