RoActemra

tocilizumab

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This is a summary of the European Public Assessment Report (EPAR) for RoActemra. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for RoActemra.

What is RoActemra?

RoActemra is a medicine that contains the active substance tocilizumab. It is available as a concentrate that is made up into a solution for infusion (drip) to be given intravenously (into a vein), and as a solution for injection to be given subcutaneously (under the skin) in a pre-filled syringe.

What is RoActemra used for?

In adults, RoActemra is used in combination with another medicine, methotrexate, to treat rheumatoid arthritis (an immune system disease causing inflammation of the joints). It is used:

  • in patients with severe, active disease who have not been previously treated with methotrexate;
  • in patients with moderate to severe active disease whose previous treatments (called disease modifying antirheumatic drugs), such as methotrexate alone or medicines known as tumour necrosis factor (TNF) blockers, have not worked well or were not tolerated.

It can be used on its own in patients where methotrexate is inappropriate. When used with methotrexate, RoActemra can slow down the damage to the joints and improve physical function (the ability to perform everyday tasks).

In children from two years of age, RoActemra is used to treat two childhood arthritis conditions, active systemic juvenile idiopathic arthritis and juvenile idiopathic polyarthritis. It is given by infusion in patients who have not responded to other treatments (NSAIDs and corticosteroids). It is used in combination with methotrexate but can be used on its own in patients for whom methotrexate is inappropriate.

The medicine can only be obtained with a prescription.

How is RoActemra used?

Treatment with RoActemra should be started by a doctor who has experience in the diagnosis and treatment of rheumatoid arthritis, active systemic juvenile idiopathic arthritis or juvenile idiopathic polyarthritis.

In rheumatoid arthritis, RoActemra can be given as an intravenous infusion or as a subcutaneous injection. When given intravenously, the recommended dose is 8 mg per kilogram body weight once every four weeks, but doses above 800 mg per infusion are not recommended. The infusion should last 1 hour. When given subcutaneously, the recommended dose is 162 mg once every week. Patients can inject themselves with the pre-filled syringe if they have been trained appropriately. The site of injection should be changed with each injection.

In systemic juvenile idiopathic arthritis, RoActemra is given as a 1-hour intravenous infusion once every two weeks at a dose of 8 mg per kilogram body weight in children weighing 30 kg or more, or 12 mg per kilogram body weight in children weighing less than 30 kg. If no improvement is seen after six weeks it may be appropriate to discontinue treatment.

In juvenile idiopathic polyarthritis, RoActemra is given as a 1-hour intravenous infusion once every four weeks at a dose of 8 mg per kilogram body weight in children weighing 30 kg or more, or 10 mg per kilogram body weight in children weighing less than 30 kg. If no improvement is seen after twelve weeks it may be appropriate to discontinue treatment.

The dose of RoActemra or methotrexate may need to be adjusted or treatment interrupted in patients who develop liver or blood problems. Doctors should monitor kidney function carefully in patients with moderately or severely reduced kidney function.

Patients who receive RoActemra should be given a special alert card that summarises the safety information about the medicine.

How does RoActemra work?

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

How has RoActemra been studied?

In severe active rheumatoid arthritis not previously treated with methotrexate, RoActemra has been investigated in one main study involving 1,162 patients. RoActemra, given by intravenous infusion on its own or in combination with methotrexate, was compared with placebo (a dummy treatment) plus methotrexate. The main measure of effectiveness was the number of patients who were in remission (did not show symptoms of the disease) after six months.

For the treatment of moderate to severe rheumatoid arthritis where other medicines have been unsuccessful, RoActemra given by intravenous infusion has been studied in five main studies involving a total of over 4,000 adults. Four of the studies compared RoActemra with placebo. In three of these, the medicines were given as an add-on to failing treatment with methotrexate or other conventional rheumatoid arthritis medicines in a total of over 3,000 patients. In the fourth study, the medicines were given in combination with methotrexate in 498 patients who had an inadequate response to previous treatment with TNF blockers. The fifth study compared RoActemra given on its own with methotrexate in a total of 673 patients.

In all five studies, the main measure of effectiveness was the number of patients who had responded to treatment after six months. A response was defined as a reduction in symptom scores of 20% or more as measured using a standard scale for rheumatoid arthritis. One of the studies, which involved 1,196 patients, also looked at the effect of the combination of RoActemra and methotrexate on joint damage and physical function after one and two years of treatment. Almost 4,000 patients from these studies went on to enter studies looking at the long-term effects of RoActemra treatment.

RoActemra given by subcutaneous injection was also investigated in two studies involving 1,918 patients with moderate to severe rheumatoid arthritis where previous treatment with DMARD had not worked well. In one study RoActemra given subcutaneously was compared with placebo, in the other study RoActemra given subcutaneously was compared with RoActemra given by intravenous infusion. The main measure of effectiveness was the number of patients who had responded to treatment after six months.

In systemic juvenile idiopathic arthritis, RoActemra given by intravenous infusion was compared with placebo in one main study involving 112 children who had inadequate responses to NSAID and systemic corticosteroid treatment. The main measure of effectiveness was the number of patients who had responded to treatment after three months and who had not had any fever for at least seven days.

In juvenile idiopathic polyarthritis, RoActemra given by intravenous infusion was compared with placebo in one main study involving 166 children from two years of age who could not take or had inadequate response to methotrexate. Patients were allowed to continue treatment with methotrexate during the study. The main measure of effectiveness was the number of patients who had a flare-up of their symptoms after four to six months of treatment.

What benefit has RoActemra shown during the studies?

After six months of treatment in patients who had not previously taken methotrexate, 130 out of 290 patients (45%) taking RoActemra in combination with methotrexate and 113 out of 292 (39%) patients taking RoActemra on its own achieved remission, compared with 43 out of 287 of those taking placebo plus methotrexate (15%).

RoActemra given by intravenous infusion was also effective at reducing the symptoms of rheumatoid arthritis in patients with an inadequate response to conventional treatments. Patients adding RoActemra were around four times more likely to respond to treatment than those adding placebo. In the patients who had an inadequate response to TNF blockers, patients receiving RoActemra with methotrexate were around nine times more likely to respond than those receiving placebo. The fifth study showed that patients receiving RoActemra on its own were more likely to respond than those taking methotrexate on its own.

The combination of RoActemra and methotrexate also slowed down the damage to the joints and improved physical function after up to two years, when compared with the combination of placebo and methotrexate.

The long-term studies showed that the response to RoActemra is maintained for at least two years.

RoActemra given by subcutaneous injection 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. When compared with RoActemra given by intravenous infusion, RoActemra given subcutaneously was no less effective in achieving a response after 6 months.

In systemic juvenile idiopathic arthritis, 85% (64 out of 75) patients treated with RoActemra given by intravenous infusion responded to treatment and no longer had fever after three months, compared with 24% (9 out of 37) patients receiving placebo.

In the juvenile idiopathic polyarthritis study, 26% of patients on RoActemra (21 out of 82) given by intravenous infusion had a flare-up of symptoms during treatment, compared with 48% of patients taking placebo (39 out of 81).

What is the risk associated with RoActemra?

The most common side effects (seen in more than 5 patient in 100) with RoActemra are upper respiratory tract infections (colds), 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 (inflammation of 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 (a disease affecting the gut) or diabetes. For the full list of restrictions, see the package leaflet.

Why has RoActemra been approved?

The CHMP 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 use of RoActemra?

A risk management plan has been developed to ensure that RoActemra is used as safely and effectively as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for RoActemra, including the appropriate precautions to be followed by healthcare professionals and patients.

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

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 18/02/2009 29/09/2014
RoActemra : EPAR - Summary for the public ES = español 18/02/2009 29/09/2014
RoActemra : EPAR - Summary for the public CS = čeština 18/02/2009 29/09/2014
RoActemra : EPAR - Summary for the public DA = dansk 18/02/2009 29/09/2014
RoActemra : EPAR - Summary for the public DE = Deutsch 18/02/2009 29/09/2014
RoActemra : EPAR - Summary for the public ET = eesti keel 18/02/2009 29/09/2014
RoActemra : EPAR - Summary for the public EL = elliniká 18/02/2009 29/09/2014
RoActemra : EPAR - Summary for the public EN = English 18/02/2009 29/09/2014
RoActemra : EPAR - Summary for the public FR = français 18/02/2009 29/09/2014
RoActemra : EPAR - Summary for the public IT = italiano 18/02/2009 29/09/2014
RoActemra : EPAR - Summary for the public LV = latviešu valoda 18/02/2009 29/09/2014
RoActemra : EPAR - Summary for the public LT = lietuvių kalba 18/02/2009 29/09/2014
RoActemra : EPAR - Summary for the public HU = magyar 18/02/2009 29/09/2014
RoActemra : EPAR - Summary for the public MT = Malti 18/02/2009 29/09/2014
RoActemra : EPAR - Summary for the public NL = Nederlands 18/02/2009 29/09/2014
RoActemra : EPAR - Summary for the public PL = polski 18/02/2009 29/09/2014
RoActemra : EPAR - Summary for the public PT = português 18/02/2009 29/09/2014
RoActemra : EPAR - Summary for the public RO = română 18/02/2009 29/09/2014
RoActemra : EPAR - Summary for the public SK = slovenčina 18/02/2009 29/09/2014
RoActemra : EPAR - Summary for the public SL = slovenščina 18/02/2009 29/09/2014
RoActemra : EPAR - Summary for the public FI = suomi 18/02/2009 29/09/2014
RoActemra : EPAR - Summary for the public SV = svenska 18/02/2009 29/09/2014
RoActemra : EPAR - Summary for the public HR = Hrvatski 18/02/2009 29/09/2014

This EPAR was last updated on 17/08/2015 .

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

Revision18
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

02/07/2015  RoActemra -EMEA/H/C/000955 -N/0053

Name Language First published Last updated
RoActemra : EPAR - Product Information HR = Hrvatski 08/01/2010 17/08/2015
RoActemra : EPAR - Product Information HR = Hrvatski 08/01/2010 17/08/2015
RoActemra : EPAR - Product Information HR = Hrvatski 08/01/2010 17/08/2015
RoActemra : EPAR - Product Information HR = Hrvatski 08/01/2010 17/08/2015
RoActemra : EPAR - Product Information HR = Hrvatski 08/01/2010 17/08/2015
RoActemra : EPAR - Product Information HR = Hrvatski 08/01/2010 17/08/2015
RoActemra : EPAR - Product Information HR = Hrvatski 08/01/2010 17/08/2015
RoActemra : EPAR - Product Information HR = Hrvatski 08/01/2010 17/08/2015
RoActemra : EPAR - Product Information HR = Hrvatski 08/01/2010 17/08/2015
RoActemra : EPAR - Product Information HR = Hrvatski 08/01/2010 17/08/2015
RoActemra : EPAR - Product Information HR = Hrvatski 08/01/2010 17/08/2015
RoActemra : EPAR - Product Information HR = Hrvatski 08/01/2010 17/08/2015
RoActemra : EPAR - Product Information HR = Hrvatski 08/01/2010 17/08/2015
RoActemra : EPAR - Product Information HR = Hrvatski 08/01/2010 17/08/2015
RoActemra : EPAR - Product Information HR = Hrvatski 08/01/2010 17/08/2015
RoActemra : EPAR - Product Information HR = Hrvatski 08/01/2010 17/08/2015
RoActemra : EPAR - Product Information HR = Hrvatski 08/01/2010 17/08/2015
RoActemra : EPAR - Product Information HR = Hrvatski 08/01/2010 17/08/2015
RoActemra : EPAR - Product Information HR = Hrvatski 08/01/2010 17/08/2015
RoActemra : EPAR - Product Information HR = Hrvatski 08/01/2010 17/08/2015
RoActemra : EPAR - Product Information HR = Hrvatski 08/01/2010 17/08/2015
RoActemra : EPAR - Product Information HR = Hrvatski 08/01/2010 17/08/2015
RoActemra : EPAR - Product Information HR = Hrvatski 08/01/2010 17/08/2015
RoActemra : EPAR - Product Information HR = Hrvatski 08/01/2010 17/08/2015
RoActemra : EPAR - Product Information HR = Hrvatski 08/01/2010 17/08/2015

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 18/02/2009 20/01/2015
RoActemra : EPAR - All Authorised presentations HR = Hrvatski 18/02/2009 20/01/2015
RoActemra : EPAR - All Authorised presentations HR = Hrvatski 18/02/2009 20/01/2015
RoActemra : EPAR - All Authorised presentations HR = Hrvatski 18/02/2009 20/01/2015
RoActemra : EPAR - All Authorised presentations HR = Hrvatski 18/02/2009 20/01/2015
RoActemra : EPAR - All Authorised presentations HR = Hrvatski 18/02/2009 20/01/2015
RoActemra : EPAR - All Authorised presentations HR = Hrvatski 18/02/2009 20/01/2015
RoActemra : EPAR - All Authorised presentations HR = Hrvatski 18/02/2009 20/01/2015
RoActemra : EPAR - All Authorised presentations HR = Hrvatski 18/02/2009 20/01/2015
RoActemra : EPAR - All Authorised presentations HR = Hrvatski 18/02/2009 20/01/2015
RoActemra : EPAR - All Authorised presentations HR = Hrvatski 18/02/2009 20/01/2015
RoActemra : EPAR - All Authorised presentations HR = Hrvatski 18/02/2009 20/01/2015
RoActemra : EPAR - All Authorised presentations HR = Hrvatski 18/02/2009 20/01/2015
RoActemra : EPAR - All Authorised presentations HR = Hrvatski 18/02/2009 20/01/2015
RoActemra : EPAR - All Authorised presentations HR = Hrvatski 18/02/2009 20/01/2015
RoActemra : EPAR - All Authorised presentations HR = Hrvatski 18/02/2009 20/01/2015
RoActemra : EPAR - All Authorised presentations HR = Hrvatski 18/02/2009 20/01/2015
RoActemra : EPAR - All Authorised presentations HR = Hrvatski 18/02/2009 20/01/2015
RoActemra : EPAR - All Authorised presentations HR = Hrvatski 18/02/2009 20/01/2015
RoActemra : EPAR - All Authorised presentations HR = Hrvatski 18/02/2009 20/01/2015
RoActemra : EPAR - All Authorised presentations HR = Hrvatski 18/02/2009 20/01/2015
RoActemra : EPAR - All Authorised presentations HR = Hrvatski 18/02/2009 20/01/2015
RoActemra : EPAR - All Authorised presentations HR = Hrvatski 18/02/2009 20/01/2015
RoActemra : EPAR - All Authorised presentations HR = Hrvatski 18/02/2009 20/01/2015
RoActemra : EPAR - All Authorised presentations HR = Hrvatski 18/02/2009 20/01/2015

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

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 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