Imnovid (previously Pomalidomide Celgene)

pomalidomide

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This is a summary of the European public assessment report (EPAR) for Imnovid. It explains how the European Medicines Agency assessed the medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use Imnovid.

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

What is Imnovid and what is it used for?

Imnovid is an anticancer medicine that contains the active substance pomalidomide. It is used in combination with dexamethasone (an anti-inflammatory medicine) to treat multiple myeloma (a cancer of the bone marrow). It is used in adults who have received at least two prior therapies, including both lenalidomide and bortezomib, and whose disease progressed after the last treatment.

Because the number of patients with multiple myeloma is low, the disease is considered ‘rare’, and Imnovid was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 8 October 2009.

How is Imnovid used?

Treatment with Imnovid must be started and supervised by a doctor experienced in treating multiple myeloma. The medicine can only be obtained with a prescription.

Imnovid is available as capsules (1, 2, 3 and 4 mg) and is taken in four-week treatment cycles. The recommended starting dose is 4 mg once a day, taken at the same time each day for the first three weeks of the cycle, followed by a week of no treatment. The recommended dose of dexamethasone is 40 mg once a day on days 1, 8, 15 and 22 of each cycle.

Treatment with Imnovid may need to be interrupted or stopped, or the dose reduced, if the disease gets worse or the patient experiences certain side effects. For further information, see the summary of product characteristics (also part of the EPAR).

How does Imnovid work?

The active substance in Imnovid, pomalidomide, is an immunomodulating agent. This means that it affects the activity of the immune system (the body’s natural defences). Pomalidomide works in a number of ways in multiple myeloma, similarly to other immunomodulating agents such as lenalidomide and thalidomide: it blocks the development of tumour cells, prevents the growth of blood vessels within tumours and also stimulates some of the specialised cells of the immune system to attack the tumour cells.

What benefits of Imnovid have been shown in studies?

Imnovid has been studied in one main study involving 455 adults with multiple myeloma, whose disease did not respond to or came back after previous treatments. The study compared Imnovid plus low-dose dexamethasone with high-dose dexamethasone alone. The main measure of effectiveness was how long it took until the disease got worse.

Imnovid plus low-dose dexamethasone was more effective than high-dose dexamethasone alone at delaying the progression of multiple myeloma: on average, it took 16 weeks before the disease got worse in patients taking Imnovid plus low-dose dexamethasone, compared with eight weeks in those taking high-dose dexamethasone.

What are the risks associated with Imnovid?

The most common side effects with Imnovid (which affect more than 1 in 10 patients), some of which were serious, include anaemia (low red-blood-cell counts), neutropenia (low white-blood-cell counts), fatigue (tiredness), thrombocytopenia (low platelet counts), pyrexia (fever), peripheral oedema (swelling, especially of the ankles and feet), peripheral neuropathy (nerve damage causing tingling, pain and numbness in the hands and feet) and pneumonia (infection of the lungs). For the full list of all side effects reported with Imnovid, see the package leaflet.

Pomalidomide is expected to be harmful to the unborn child, causing severe and life-threatening birth defects. Therefore, Imnovid must not be used in women who are pregnant. It must not be used in women who could become pregnant, unless they take all of the necessary steps to ensure that they are not pregnant before treatment and that they do not become pregnant during or soon after treatment. As the medicine can be found in semen, the medicine must also not be used in male patients who are unable to comply with the required contraceptive measures. For the full list of restrictions, see the package leaflet.

Why is Imnovid approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Imnovid’s benefits are greater than its risks and recommended that it be approved for use in the EU. The Committee concluded that Imnovid is effective at delaying the progression of multiple myeloma in patients whose disease does not respond to or comes back after previous treatment, who have very limited treatment options. The Committee also noted that the safety profile of Imnovid was considered acceptable for these patients, with side effects similar to those of other medicines of this type.

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

A risk-management plan has been developed to ensure that Imnovid 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 Imnovid, including the appropriate precautions to be followed by healthcare professionals and patients.

In addition, the company that makes Imnovid will set up a pregnancy-prevention programme in each Member State. It will provide a letter and educational kits for healthcare workers, and brochures for patients, explaining that the medicine is expected to be harmful to the unborn child and detailing the steps that need to be taken for the medicine to be used safely. It will also supply cards for patients to ensure that all appropriate safety measures have been taken by each patient. Each Member State will also ensure that educational materials and patient cards are provided to prescribers and patients.

The company will also set up a registry of patients treated with Imnovid in order to monitor the side effects reported and whether the medicine is used within its approved indication and in compliance with the pregnancy-prevention programme. The medicine packs containing Imnovid capsules will carry a warning on the risk of severe birth defects.

Other information about Imnovid

The European Commission granted a marketing authorisation valid throughout the European Union for Pomalidomide Celgene on 5 August 2013. The name of the medicine was changed to Imnovid on 27 August 2013.

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

Name Language First published Last updated
Imnovid : EPAR - Summary for the public BG = bălgarski 13/08/2013 10/10/2013
Imnovid : EPAR - Summary for the public ES = español 13/08/2013 10/10/2013
Imnovid : EPAR - Summary for the public CS = čeština 13/08/2013 10/10/2013
Imnovid : EPAR - Summary for the public DA = dansk 13/08/2013 10/10/2013
Imnovid : EPAR - Summary for the public DE = Deutsch 13/08/2013 10/10/2013
Imnovid : EPAR - Summary for the public ET = eesti keel 13/08/2013 10/10/2013
Imnovid : EPAR - Summary for the public EL = elliniká 13/08/2013 10/10/2013
Imnovid : EPAR - Summary for the public EN = English 13/08/2013 10/10/2013
Imnovid : EPAR - Summary for the public FR = français 13/08/2013 10/10/2013
Imnovid : EPAR - Summary for the public IT = italiano 13/08/2013 10/10/2013
Imnovid : EPAR - Summary for the public LV = latviešu valoda 13/08/2013 10/10/2013
Imnovid : EPAR - Summary for the public LT = lietuvių kalba 13/08/2013 10/10/2013
Imnovid : EPAR - Summary for the public HU = magyar 13/08/2013 10/10/2013
Imnovid : EPAR - Summary for the public MT = Malti 13/08/2013 10/10/2013
Imnovid : EPAR - Summary for the public NL = Nederlands 13/08/2013 10/10/2013
Imnovid : EPAR - Summary for the public PL = polski 13/08/2013 10/10/2013
Imnovid : EPAR - Summary for the public PT = português 13/08/2013 10/10/2013
Imnovid : EPAR - Summary for the public RO = română 13/08/2013 10/10/2013
Imnovid : EPAR - Summary for the public SK = slovenčina 13/08/2013 10/10/2013
Imnovid : EPAR - Summary for the public SL = slovenščina 13/08/2013 10/10/2013
Imnovid : EPAR - Summary for the public FI = suomi 13/08/2013 10/10/2013
Imnovid : EPAR - Summary for the public SV = svenska 13/08/2013 10/10/2013
Imnovid : EPAR - Summary for the public HR = Hrvatski 13/08/2013 10/10/2013

This EPAR was last updated on 18/08/2014 .

Authorisation details

Product details

Product details for Imnovid (previously Pomalidomide Celgene)
NameImnovid (previously Pomalidomide Celgene)
Agency product numberEMEA/H/C/002682
Active substance

pomalidomide

International non-proprietary name (INN) or common name

pomalidomide

Therapeutic area Multiple Myeloma
Anatomical therapeutic chemical (ATC) code
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.

Treatment of rare diseases

This medicine has an "orphan designation" which means that it is used to treat life-threatening or chronically debilitating conditions that affect no more than five in 10,000 people in the European Union, or are medicines which, for economic reasons, would be unlikely to be developed without incentives.

Publication details

Publication details for Imnovid (previously Pomalidomide Celgene)
Marketing-authorisation holder

Celgene Europe Ltd

Revision2
Date of issue of marketing authorisation valid throughout the European Union05/08/2013

Contact address:

Celgene Europe Ltd
1 Longwalk Road
Stockley Park
Uxbridge
UB11 1DB
United Kingdom

Product information

Product information

28/07/2014  Imnovid (previously Pomalidomide Celgene) -EMEA/H/C/002682 -IB/0007

Name Language First published Last updated
Imnovid : EPAR - Product Information HR = Hrvatski 13/08/2013 18/08/2014
Imnovid : EPAR - Product Information HR = Hrvatski 13/08/2013 18/08/2014
Imnovid : EPAR - Product Information HR = Hrvatski 13/08/2013 18/08/2014
Imnovid : EPAR - Product Information HR = Hrvatski 13/08/2013 18/08/2014
Imnovid : EPAR - Product Information HR = Hrvatski 13/08/2013 18/08/2014
Imnovid : EPAR - Product Information HR = Hrvatski 13/08/2013 18/08/2014
Imnovid : EPAR - Product Information HR = Hrvatski 13/08/2013 18/08/2014
Imnovid : EPAR - Product Information HR = Hrvatski 13/08/2013 18/08/2014
Imnovid : EPAR - Product Information HR = Hrvatski 13/08/2013 18/08/2014
Imnovid : EPAR - Product Information HR = Hrvatski 13/08/2013 18/08/2014
Imnovid : EPAR - Product Information HR = Hrvatski 13/08/2013 18/08/2014
Imnovid : EPAR - Product Information HR = Hrvatski 13/08/2013 18/08/2014
Imnovid : EPAR - Product Information HR = Hrvatski 13/08/2013 18/08/2014
Imnovid : EPAR - Product Information HR = Hrvatski 13/08/2013 18/08/2014
Imnovid : EPAR - Product Information HR = Hrvatski 13/08/2013 18/08/2014
Imnovid : EPAR - Product Information HR = Hrvatski 13/08/2013 18/08/2014
Imnovid : EPAR - Product Information HR = Hrvatski 13/08/2013 18/08/2014
Imnovid : EPAR - Product Information HR = Hrvatski 13/08/2013 18/08/2014
Imnovid : EPAR - Product Information HR = Hrvatski 13/08/2013 18/08/2014
Imnovid : EPAR - Product Information HR = Hrvatski 13/08/2013 18/08/2014
Imnovid : EPAR - Product Information HR = Hrvatski 13/08/2013 18/08/2014
Imnovid : EPAR - Product Information HR = Hrvatski 13/08/2013 18/08/2014
Imnovid : EPAR - Product Information HR = Hrvatski 13/08/2013 18/08/2014
Imnovid : EPAR - Product Information HR = Hrvatski 13/08/2013 18/08/2014
Imnovid : EPAR - Product Information HR = Hrvatski 13/08/2013 18/08/2014

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
Imnovid : EPAR - All Authorised presentations HR = Hrvatski 13/08/2013 10/10/2013
Imnovid : EPAR - All Authorised presentations HR = Hrvatski 13/08/2013 10/10/2013
Imnovid : EPAR - All Authorised presentations HR = Hrvatski 13/08/2013 10/10/2013
Imnovid : EPAR - All Authorised presentations HR = Hrvatski 13/08/2013 10/10/2013
Imnovid : EPAR - All Authorised presentations HR = Hrvatski 13/08/2013 10/10/2013
Imnovid : EPAR - All Authorised presentations HR = Hrvatski 13/08/2013 10/10/2013
Imnovid : EPAR - All Authorised presentations HR = Hrvatski 13/08/2013 10/10/2013
Imnovid : EPAR - All Authorised presentations HR = Hrvatski 13/08/2013 10/10/2013
Imnovid : EPAR - All Authorised presentations HR = Hrvatski 13/08/2013 10/10/2013
Imnovid : EPAR - All Authorised presentations HR = Hrvatski 13/08/2013 10/10/2013
Imnovid : EPAR - All Authorised presentations HR = Hrvatski 13/08/2013 10/10/2013
Imnovid : EPAR - All Authorised presentations HR = Hrvatski 13/08/2013 10/10/2013
Imnovid : EPAR - All Authorised presentations HR = Hrvatski 13/08/2013 10/10/2013
Imnovid : EPAR - All Authorised presentations HR = Hrvatski 13/08/2013 10/10/2013
Imnovid : EPAR - All Authorised presentations HR = Hrvatski 13/08/2013 10/10/2013
Imnovid : EPAR - All Authorised presentations HR = Hrvatski 13/08/2013 10/10/2013
Imnovid : EPAR - All Authorised presentations HR = Hrvatski 13/08/2013 10/10/2013
Imnovid : EPAR - All Authorised presentations HR = Hrvatski 13/08/2013 10/10/2013
Imnovid : EPAR - All Authorised presentations HR = Hrvatski 13/08/2013 10/10/2013
Imnovid : EPAR - All Authorised presentations HR = Hrvatski 13/08/2013 10/10/2013
Imnovid : EPAR - All Authorised presentations HR = Hrvatski 13/08/2013 10/10/2013
Imnovid : EPAR - All Authorised presentations HR = Hrvatski 13/08/2013 10/10/2013
Imnovid : EPAR - All Authorised presentations HR = Hrvatski 13/08/2013 10/10/2013
Imnovid : EPAR - All Authorised presentations HR = Hrvatski 13/08/2013 10/10/2013
Imnovid : EPAR - All Authorised presentations HR = Hrvatski 13/08/2013 10/10/2013

Name Language First published Last updated
Pomalidomide Celgene : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 13/08/2013  
Pomalidomide Celgene : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 13/08/2013  
Pomalidomide Celgene : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 13/08/2013  
Pomalidomide Celgene : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 13/08/2013  
Pomalidomide Celgene : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 13/08/2013  
Pomalidomide Celgene : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 13/08/2013  
Pomalidomide Celgene : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 13/08/2013  
Pomalidomide Celgene : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 13/08/2013  
Pomalidomide Celgene : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 13/08/2013  
Pomalidomide Celgene : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 13/08/2013  
Pomalidomide Celgene : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 13/08/2013  
Pomalidomide Celgene : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 13/08/2013  
Pomalidomide Celgene : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 13/08/2013  
Pomalidomide Celgene : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 13/08/2013  
Pomalidomide Celgene : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 13/08/2013  
Pomalidomide Celgene : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 13/08/2013  
Pomalidomide Celgene : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 13/08/2013  
Pomalidomide Celgene : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 13/08/2013  
Pomalidomide Celgene : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 13/08/2013  
Pomalidomide Celgene : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 13/08/2013  
Pomalidomide Celgene : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 13/08/2013  
Pomalidomide Celgene : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 13/08/2013  
Pomalidomide Celgene : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 13/08/2013  
Pomalidomide Celgene : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 13/08/2013  
Pomalidomide Celgene : EPAR - Conditions imposed on member states for safe and effective use HR = Hrvatski 13/08/2013  

Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

Imnovid in combination with dexamethasone is indicated in the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Imnovid : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 10/10/2013 18/08/2014

Initial marketing-authorisation documents

Name Language First published Last updated
Pomalidomide Celgene : EPAR - Public assessment report HR = Hrvatski 13/08/2013  
CHMP summary of positive opinion for Pomalidomide Celgene HR = Hrvatski 31/05/2013  

Authorised

This medicine is approved for use in the European Union