Empliciti

elotuzumab

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

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

What is Empliciti and what is it used for?

Empliciti is a medicine for treating multiple myeloma (a cancer of the bone marrow). It is used together with two other medicines (lenalidomide and dexamethasone) and is given to adults who have tried at least one previous cancer treatment.

Empliciti contains the active substance elotuzumab.

How is Empliciti used?

Empliciti is given as an infusion (drip) into a vein. Treatment takes place in 28-day cycles, with Empliciti given once a week in the first 2 cycles (on days 1, 8, 15 and 22) and once every 2 weeks in subsequent cycles (days 1 and 15). The dose is 10 mg per kilogram body weight.

Because of the risk of infusion reactions, the patient is to be given preventive treatment consisting of an anti-inflammatory medicine, an antihistamine and paracetamol before every infusion. In addition, during each 28-day cycle, the patient also receives cancer treatment with lenalidomide and dexamethasone.

Empliciti is available as a powder to be made up into a solution. Treatment must be started and supervised by a doctor experienced in treating multiple myeloma, and the medicine can only be obtained with a prescription.

How does Empliciti work?

The active substance in Empliciti, elotuzumab, is a monoclonal antibody that activates the body’s immune cells to attack the multiple myeloma cancer cells. It does this by attaching to a protein on the surface of the immune cells called SLAMF7, causing them to act against the cancer cells and thereby slow down the disease.

Elotuzumab also attaches to SLAMF7 on the cancer cells, making them more vulnerable to attack by the immune cells.

What benefits of Empliciti have been shown in studies?

A main study of 646 multiple myeloma patients compared the effects of taking Empliciti plus lenalidomide and dexamethasone with the effects of taking only lenalidomide and dexamethasone. In this study, adding Empliciti to the two other medicines extended the average time before the disease got worse from 14.3 months to 18.5 months. In addition, more patients had a partial or complete clearing of their cancer with the Empliciti combination (79% of patients) than with only the other two medicines (66% of patients).

All patients in the study had previously tried other treatments but their disease had either not responded or had come back.

What are the risks associated with Empliciti?

The most common side effects with Empliciti (which may affect more than 1 in 10 people) are infusion reactions (with symptoms such as fever and chills), diarrhoea, shingles (painful, blistering rash), sore throat, cough, pneumonia (lung infection), colds, low levels of white blood cells and weight loss. The majority of side effects are mild or moderate in severity, and the most serious is pneumonia. For the full list of all side effects, see the package leaflet.

Why is Empliciti approved?

The main study showed that adding Empliciti to lenalidomide and dexamethasone can delay the worsening of multiple myeloma and improve response rates in patients whose disease had come back or did not respond to previous treatment. Although side effects, particularly infections, were more common with Empliciti, the risks on the whole appear manageable.

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

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

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

Other information about Empliciti

The European Commission granted a marketing authorisation valid throughout the European Union for Empliciti on 11 May 2016.

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

Name Language First published Last updated
Empliciti : EPAR - Summary for the public BG = bălgarski 2016-05-19  
Empliciti : EPAR - Summary for the public ES = español 2016-05-19  
Empliciti : EPAR - Summary for the public CS = čeština 2016-05-19  
Empliciti : EPAR - Summary for the public DA = dansk 2016-05-19  
Empliciti : EPAR - Summary for the public DE = Deutsch 2016-05-19  
Empliciti : EPAR - Summary for the public ET = eesti keel 2016-05-19  
Empliciti : EPAR - Summary for the public EL = elliniká 2016-05-19  
Empliciti : EPAR - Summary for the public EN = English 2016-05-19  
Empliciti : EPAR - Summary for the public FR = français 2016-05-19  
Empliciti : EPAR - Summary for the public IT = italiano 2016-05-19  
Empliciti : EPAR - Summary for the public LV = latviešu valoda 2016-05-19  
Empliciti : EPAR - Summary for the public LT = lietuvių kalba 2016-05-19  
Empliciti : EPAR - Summary for the public HU = magyar 2016-05-19  
Empliciti : EPAR - Summary for the public MT = Malti 2016-05-19  
Empliciti : EPAR - Summary for the public NL = Nederlands 2016-05-19  
Empliciti : EPAR - Summary for the public PL = polski 2016-05-19  
Empliciti : EPAR - Summary for the public PT = português 2016-05-19  
Empliciti : EPAR - Summary for the public RO = română 2016-05-19  
Empliciti : EPAR - Summary for the public SK = slovenčina 2016-05-19  
Empliciti : EPAR - Summary for the public SL = slovenščina 2016-05-19  
Empliciti : EPAR - Summary for the public FI = suomi 2016-05-19  
Empliciti : EPAR - Summary for the public SV = svenska 2016-05-19  
Empliciti : EPAR - Summary for the public HR = Hrvatski 2016-05-19  

This EPAR was last updated on 15/12/2016 .

Authorisation details

Product details

Product details for Empliciti
NameEmpliciti
Agency product numberEMEA/H/C/003967
Active substance

elotuzumab

International non-proprietary name (INN) or common name

elotuzumab

Therapeutic area Multiple Myeloma
Anatomical therapeutic chemical (ATC) code L01XC
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 Empliciti
Marketing-authorisation holder

Bristol-Myers Squibb

Revision1
Date of issue of marketing authorisation valid throughout the European Union11/05/2016

Contact address:

Bristol-Myers Squibb
Uxbridge Business Park
Sanderson Road, Uxbridge
Middlesex UB8 1DH
United Kingdom

Product information

Product information

10/11/2016  Empliciti -EMEA/H/C/003967 -II/001/G

Name Language First published Last updated
Empliciti : EPAR - Product Information HR = Hrvatski 2016-05-19 2016-12-15
Empliciti : EPAR - Product Information HR = Hrvatski 2016-05-19 2016-12-15
Empliciti : EPAR - Product Information HR = Hrvatski 2016-05-19 2016-12-15
Empliciti : EPAR - Product Information HR = Hrvatski 2016-05-19 2016-12-15
Empliciti : EPAR - Product Information HR = Hrvatski 2016-05-19 2016-12-15
Empliciti : EPAR - Product Information HR = Hrvatski 2016-05-19 2016-12-15
Empliciti : EPAR - Product Information HR = Hrvatski 2016-05-19 2016-12-15
Empliciti : EPAR - Product Information HR = Hrvatski 2016-05-19 2016-12-15
Empliciti : EPAR - Product Information HR = Hrvatski 2016-05-19 2016-12-15
Empliciti : EPAR - Product Information HR = Hrvatski 2016-05-19 2016-12-15
Empliciti : EPAR - Product Information HR = Hrvatski 2016-05-19 2016-12-15
Empliciti : EPAR - Product Information HR = Hrvatski 2016-05-19 2016-12-15
Empliciti : EPAR - Product Information HR = Hrvatski 2016-05-19 2016-12-15
Empliciti : EPAR - Product Information HR = Hrvatski 2016-05-19 2016-12-15
Empliciti : EPAR - Product Information HR = Hrvatski 2016-05-19 2016-12-15
Empliciti : EPAR - Product Information HR = Hrvatski 2016-05-19 2016-12-15
Empliciti : EPAR - Product Information HR = Hrvatski 2016-05-19 2016-12-15
Empliciti : EPAR - Product Information HR = Hrvatski 2016-05-19 2016-12-15
Empliciti : EPAR - Product Information HR = Hrvatski 2016-05-19 2016-12-15
Empliciti : EPAR - Product Information HR = Hrvatski 2016-05-19 2016-12-15
Empliciti : EPAR - Product Information HR = Hrvatski 2016-05-19 2016-12-15
Empliciti : EPAR - Product Information HR = Hrvatski 2016-05-19 2016-12-15
Empliciti : EPAR - Product Information HR = Hrvatski 2016-05-19 2016-12-15
Empliciti : EPAR - Product Information HR = Hrvatski 2016-05-19 2016-12-15
Empliciti : EPAR - Product Information HR = Hrvatski 2016-05-19 2016-12-15

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
Empliciti : EPAR - All Authorised presentations HR = Hrvatski 2016-05-19  
Empliciti : EPAR - All Authorised presentations HR = Hrvatski 2016-05-19  
Empliciti : EPAR - All Authorised presentations HR = Hrvatski 2016-05-19  
Empliciti : EPAR - All Authorised presentations HR = Hrvatski 2016-05-19  
Empliciti : EPAR - All Authorised presentations HR = Hrvatski 2016-05-19  
Empliciti : EPAR - All Authorised presentations HR = Hrvatski 2016-05-19  
Empliciti : EPAR - All Authorised presentations HR = Hrvatski 2016-05-19  
Empliciti : EPAR - All Authorised presentations HR = Hrvatski 2016-05-19  
Empliciti : EPAR - All Authorised presentations HR = Hrvatski 2016-05-19  
Empliciti : EPAR - All Authorised presentations HR = Hrvatski 2016-05-19  
Empliciti : EPAR - All Authorised presentations HR = Hrvatski 2016-05-19  
Empliciti : EPAR - All Authorised presentations HR = Hrvatski 2016-05-19  
Empliciti : EPAR - All Authorised presentations HR = Hrvatski 2016-05-19  
Empliciti : EPAR - All Authorised presentations HR = Hrvatski 2016-05-19  
Empliciti : EPAR - All Authorised presentations HR = Hrvatski 2016-05-19  
Empliciti : EPAR - All Authorised presentations HR = Hrvatski 2016-05-19  
Empliciti : EPAR - All Authorised presentations HR = Hrvatski 2016-05-19  
Empliciti : EPAR - All Authorised presentations HR = Hrvatski 2016-05-19  
Empliciti : EPAR - All Authorised presentations HR = Hrvatski 2016-05-19  
Empliciti : EPAR - All Authorised presentations HR = Hrvatski 2016-05-19  
Empliciti : EPAR - All Authorised presentations HR = Hrvatski 2016-05-19  
Empliciti : EPAR - All Authorised presentations HR = Hrvatski 2016-05-19  
Empliciti : EPAR - All Authorised presentations HR = Hrvatski 2016-05-19  
Empliciti : EPAR - All Authorised presentations HR = Hrvatski 2016-05-19  
Empliciti : EPAR - All Authorised presentations HR = Hrvatski 2016-05-19  

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Empliciti is indicated in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Empliciti : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2016-12-15  

Initial marketing-authorisation documents

Name Language First published Last updated
Empliciti : EPAR - Public assessment report HR = Hrvatski 2016-05-19  
CHMP summary of opinion for Empliciti HR = Hrvatski 2016-01-29  

Authorised

This medicine is approved for use in the European Union

More information on Empliciti

This product is no longer an orphan medicine. It was originally designated an orphan medicine on 9 August 2012. Empliciti was withdrawn from the Community register of orphan medicinal products by the European Commission in April 2016, at the time of the granting of a marketing authorisation.