Kevzara

sarilumab

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This is a summary of the European public assessment report (EPAR) for Kevzara. 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 Kevzara.

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

What is Kevzara and what is it used for?

Kevzara is a medicine for treating adults with moderate to severe rheumatoid arthritis, a disease that causes inflammation of the joints.

Kevzara is used when treatment with one or more medicines known as disease-modifying anti-rheumatic drugs (DMARDs) has not worked well enough or has led to troublesome side effects. It is used with methotrexate (a DMARD) but can also be used alone if the patient cannot take methotrexate.

Kevzara contains the active substance sarilumab.

How is Kevzara used?

Kevzara is available as a solution for injection in pre-filled pens and pre-filled syringes (150 mg and 200 mg). The recommended dose is 200 mg given as an injection under the skin, once every 2 weeks.

Treatment should be interrupted in patients who develop serious infections until the infection is under control. The dose may have to be lowered in patients with abnormal blood tests. For more information, see the package leaflet.

Kevzara can only be obtained with a prescription, and treatment should be started and supervised by a specialist doctor experienced in treating rheumatoid arthritis.

How does Kevzara work?

The active substance in Kevzara, sarilumab, is a monoclonal antibody, a type of protein which has been designed to attach to and block the receptor (target) for a molecule called interleukin-6. Interleukin-6 is involved in causing inflammation and is found at high levels in the joints of patients with rheumatoid arthritis. By preventing interleukin-6 from attaching to its receptors, sarilumab reduces inflammation and other symptoms associated with rheumatoid arthritis.

What benefits of Kevzara have been shown in studies?

Three studies involving over 2,100 adults with rheumatoid arthritis showed that Kevzara is effective at reducing joint pain and swelling, improving joint movement and slowing down joint damage after 24 weeks of treatment.

The first study involved about 1,200 patients whose condition had not responded adequately to treatment with methotrexate; patients received Kevzara plus methotrexate or placebo plus methotrexate. 58% of patients given Kevzara 150 mg and 66% of patients given Kevzara 200 mg had a reduction in symptoms of 20% or more, based on a standard rating score (ACR 20). This compared with 33% of the patients receiving placebo.

A second study involved 546 patients whose condition had not responded adequately to, or who could not take, a TNF-α inhibitor (another type of medicine for rheumatoid arthritis); all patients received Kevzara or placebo in combination with a DMARD. 56% of patients treated with Kevzara 150 mg and 61% of those treated with 200 mg had a reduction in symptoms of 20% or more, compared with 34% of patients on placebo.

A third study involving 369 patients compared Kevzara with adalimumab (another monoclonal antibody for the treatment of rheumatoid arthritis). Patients treated with Kevzara had greater improvement in the function of their joints, compared with patients treated with adalimumab (based on a standard rating score called DAS28-ESR).

What are the risks associated with Kevzara?

The most common side effect with Kevzara (which may affect more than 1 in 10 people) is neutropenia (low levels of neutrophils, a type of white blood cell that fights infection). Increased blood levels of a liver enzyme called ALT (a sign of liver problems), reddening of the skin at the site of injection, nose and throat infections, and infections of the structures that carry urine (such as the bladder) are also common side effects which may affect up to 1 in 10 people.

Kevzara must not be used in patients with active, severe infections including infections localised to one area of the body. For the full list of side effects and restrictions, see the package leaflet.

Why is Kevzara approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Kevzara’s benefits are greater than its risks and recommended that it be approved for use in the EU.

Kevzara was shown to be of benefit to patients with moderate to severe rheumatoid arthritis whose condition did not improve adequately or who were intolerant to one or more DMARD medicines. The benefits seen in studies include reduced symptoms, improved physical function, and slower progression of joint damage.

The safety profile of Kevzara was considered acceptable and in line with that of other similar medicines. Most side effects were mild to moderate in severity, and the more severe side effects were considered manageable with dose reduction or treatment interruption.

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

The company that markets Kevzara will provide an alert card for patients, highlighting the risk of serious infections, neutropenia and intestinal perforation (a hole that develops in the wall of the gut), and listing the symptoms for which patients should seek immediate medical attention.

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

Other information about Kevzara

The European Commission granted a marketing authorisation valid throughout the European Union for Kevzara on 23 June 2017.

For more information about treatment with Kevzara, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Kevzara : EPAR - Summary for the public BG = bălgarski 2017-06-29  
Kevzara : EPAR - Summary for the public ES = español 2017-06-29  
Kevzara : EPAR - Summary for the public CS = čeština 2017-06-29  
Kevzara : EPAR - Summary for the public DA = dansk 2017-06-29  
Kevzara : EPAR - Summary for the public DE = Deutsch 2017-06-29  
Kevzara : EPAR - Summary for the public ET = eesti keel 2017-06-29  
Kevzara : EPAR - Summary for the public EL = elliniká 2017-06-29  
Kevzara : EPAR - Summary for the public EN = English 2017-06-29  
Kevzara : EPAR - Summary for the public FR = français 2017-06-29  
Kevzara : EPAR - Summary for the public IT = italiano 2017-06-29  
Kevzara : EPAR - Summary for the public LV = latviešu valoda 2017-06-29  
Kevzara : EPAR - Summary for the public LT = lietuvių kalba 2017-06-29  
Kevzara : EPAR - Summary for the public HU = magyar 2017-06-29  
Kevzara : EPAR - Summary for the public MT = Malti 2017-06-29  
Kevzara : EPAR - Summary for the public NL = Nederlands 2017-06-29  
Kevzara : EPAR - Summary for the public PL = polski 2017-06-29  
Kevzara : EPAR - Summary for the public PT = português 2017-06-29  
Kevzara : EPAR - Summary for the public RO = română 2017-06-29  
Kevzara : EPAR - Summary for the public SK = slovenčina 2017-06-29  
Kevzara : EPAR - Summary for the public SL = slovenščina 2017-06-29  
Kevzara : EPAR - Summary for the public FI = suomi 2017-06-29  
Kevzara : EPAR - Summary for the public SV = svenska 2017-06-29  
Kevzara : EPAR - Summary for the public HR = Hrvatski 2017-06-29  

This EPAR was last updated on 26/09/2017 .

Authorisation details

Product details

Product details for Kevzara
NameKevzara
Agency product numberEMEA/H/C/004254
Active substance

sarilumab

International non-proprietary name (INN) or common name

sarilumab

Therapeutic area Arthritis, Rheumatoid
Anatomical therapeutic chemical (ATC) code L04AC14
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Publication details

Publication details for Kevzara
Marketing-authorisation holder

sanofi-aventis groupe

Revision1
Date of issue of marketing authorisation valid throughout the European Union23/06/2017

Contact address:

sanofi-aventis groupe
54 Rue La Boetie 
75008 Paris 
France

Product information

Product information

24/08/2017  Kevzara -EMEA/H/C/004254 -IB/0002/G

Name Language First published Last updated
Kevzara : EPAR - Product Information HR = Hrvatski 2017-06-29 2017-09-26
Kevzara : EPAR - Product Information HR = Hrvatski 2017-06-29 2017-09-26
Kevzara : EPAR - Product Information HR = Hrvatski 2017-06-29 2017-09-26
Kevzara : EPAR - Product Information HR = Hrvatski 2017-06-29 2017-09-26
Kevzara : EPAR - Product Information HR = Hrvatski 2017-06-29 2017-09-26
Kevzara : EPAR - Product Information HR = Hrvatski 2017-06-29 2017-09-26
Kevzara : EPAR - Product Information HR = Hrvatski 2017-06-29 2017-09-26
Kevzara : EPAR - Product Information HR = Hrvatski 2017-06-29 2017-09-26
Kevzara : EPAR - Product Information HR = Hrvatski 2017-06-29 2017-09-26
Kevzara : EPAR - Product Information HR = Hrvatski 2017-06-29 2017-09-26
Kevzara : EPAR - Product Information HR = Hrvatski 2017-06-29 2017-09-26
Kevzara : EPAR - Product Information HR = Hrvatski 2017-06-29 2017-09-26
Kevzara : EPAR - Product Information HR = Hrvatski 2017-06-29 2017-09-26
Kevzara : EPAR - Product Information HR = Hrvatski 2017-06-29 2017-09-26
Kevzara : EPAR - Product Information HR = Hrvatski 2017-06-29 2017-09-26
Kevzara : EPAR - Product Information HR = Hrvatski 2017-06-29 2017-09-26
Kevzara : EPAR - Product Information HR = Hrvatski 2017-06-29 2017-09-26
Kevzara : EPAR - Product Information HR = Hrvatski 2017-06-29 2017-09-26
Kevzara : EPAR - Product Information HR = Hrvatski 2017-06-29 2017-09-26
Kevzara : EPAR - Product Information HR = Hrvatski 2017-06-29 2017-09-26
Kevzara : EPAR - Product Information HR = Hrvatski 2017-06-29 2017-09-26
Kevzara : EPAR - Product Information HR = Hrvatski 2017-06-29 2017-09-26
Kevzara : EPAR - Product Information HR = Hrvatski 2017-06-29 2017-09-26
Kevzara : EPAR - Product Information HR = Hrvatski 2017-06-29 2017-09-26
Kevzara : EPAR - Product Information HR = Hrvatski 2017-06-29 2017-09-26

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
Kevzara : EPAR - All Authorised presentations HR = Hrvatski 2017-06-29 2017-09-26
Kevzara : EPAR - All Authorised presentations HR = Hrvatski 2017-06-29 2017-09-26
Kevzara : EPAR - All Authorised presentations HR = Hrvatski 2017-06-29 2017-09-26
Kevzara : EPAR - All Authorised presentations HR = Hrvatski 2017-06-29 2017-09-26
Kevzara : EPAR - All Authorised presentations HR = Hrvatski 2017-06-29 2017-09-26
Kevzara : EPAR - All Authorised presentations HR = Hrvatski 2017-06-29 2017-09-26
Kevzara : EPAR - All Authorised presentations HR = Hrvatski 2017-06-29 2017-09-26
Kevzara : EPAR - All Authorised presentations HR = Hrvatski 2017-06-29 2017-09-26
Kevzara : EPAR - All Authorised presentations HR = Hrvatski 2017-06-29 2017-09-26
Kevzara : EPAR - All Authorised presentations HR = Hrvatski 2017-06-29 2017-09-26
Kevzara : EPAR - All Authorised presentations HR = Hrvatski 2017-06-29 2017-09-26
Kevzara : EPAR - All Authorised presentations HR = Hrvatski 2017-06-29 2017-09-26
Kevzara : EPAR - All Authorised presentations HR = Hrvatski 2017-06-29 2017-09-26
Kevzara : EPAR - All Authorised presentations HR = Hrvatski 2017-06-29 2017-09-26
Kevzara : EPAR - All Authorised presentations HR = Hrvatski 2017-06-29 2017-09-26
Kevzara : EPAR - All Authorised presentations HR = Hrvatski 2017-06-29 2017-09-26
Kevzara : EPAR - All Authorised presentations HR = Hrvatski 2017-06-29 2017-09-26
Kevzara : EPAR - All Authorised presentations HR = Hrvatski 2017-06-29 2017-09-26
Kevzara : EPAR - All Authorised presentations HR = Hrvatski 2017-06-29 2017-09-26
Kevzara : EPAR - All Authorised presentations HR = Hrvatski 2017-06-29 2017-09-26
Kevzara : EPAR - All Authorised presentations HR = Hrvatski 2017-06-29 2017-09-26
Kevzara : EPAR - All Authorised presentations HR = Hrvatski 2017-06-29 2017-09-26
Kevzara : EPAR - All Authorised presentations HR = Hrvatski 2017-06-29 2017-09-26
Kevzara : EPAR - All Authorised presentations HR = Hrvatski 2017-06-29 2017-09-26
Kevzara : EPAR - All Authorised presentations HR = Hrvatski 2017-06-29 2017-09-26

Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

Kevzara in combination with methotrexate (MTX) is indicated for the treatment of moderately to severely active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (DMARDs). Kevzara can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Kevzara : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2017-09-26  

Initial marketing-authorisation documents

Name Language First published Last updated
Kevzara : EPAR - Public assessment report HR = Hrvatski 2017-06-29  
CHMP summary of positive opinion for Kevzara HR = Hrvatski 2017-04-21  

Authorised

This medicine is approved for use in the European Union