Revlimid

lenalidomide

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

What is Revlimid?

Revlimid is a cancer medicine that contains the active substance lenalidomide. It is available as capsules (2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg and 25 mg).

What is Revlimid used for?

Revlimid is used to treat multiple myeloma, a cancer of the plasma cells in the bone marrow, as follows:

  • in combination with dexamethasone (an anti-inflammatory medicine), in adults whose disease has been treated at least once in the past;
  • for the treatment of adults with previously untreated (newly diagnosed) multiple myeloma, who are not eligible for bone marrow transplant.

Revlimid is also used in patients with transfusion-dependent anaemia (low red blood cell counts, which are severe enough to require blood transfusions) due to myelodysplastic syndromes (a group of bone marrow disorders that can cause anaemia). In some cases, myelodysplastic syndromes can lead to acute myeloid leukaemia (AML, a type of cancer affecting white blood cells). Revlimid is used in patients who have a genetic abnormality (called deletion 5q) and are at a lower risk of AML, and it is used when other treatments are not adequate.

Because the number of patients with these diseases is low, the diseases are considered ‘rare’, and Revlimid was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 12 December 2003 and 8 March 2004.

The medicine can only be obtained with a prescription.

How is Revlimid used?

Treatment with Revlimid must be monitored by doctors who have experience in the use of cancer medicines.

Revlimid is taken in repeated 28-day cycles: the patient takes the medicine once a day for 21 days at around the same time each day, followed by seven days off the medicine.

In the treatment of patients with multiple myeloma who have received at least one prior therapy, the recommended dose of Revlimid is 25 mg a day.

In the treatment of newly diagnosed multiple myeloma, the recommended dose ranges between 10 and 25 mg per day, depending on the other cancer medicines the patient is taking.

In the treatment of myelodysplastic syndromes, the recommended dose of Revlimid is 10 mg a day.

The dose of Revlimid should be reduced or treatment interrupted depending on the patient’s condition and the levels of platelets (components that help the blood to clot) and of neutrophils (a type of white blood cell). A lower dose should also be used in patients who have moderate or more severe problems with their kidneys. For more information, see the summary of product characteristics (also part of the EPAR).

How does Revlimid work?

The active substance in Revlimid, lenalidomide, is an immunomodulating agent. This means that it affects the activity of the immune system (the body’s natural defences). Lenalidomide works in a number of different ways: it blocks the development of abnormal cells, prevents the growth of blood vessels within tumours and also stimulates some of the specialised cells of the immune system to attack the abnormal cells.

How has Revlimid been studied?

Revlimid has been studied in two main studies involving 704 patients with previously treated multiple myeloma. In both studies, Revlimid was compared with placebo (a dummy treatment), both taken in combination with dexamethasone. The main measure of effectiveness was how long it took until the disease got worse.

In newly diagnosed multiple myeloma, Revlimid has been studied in two main studies, involving a total of around 2,000 patients, which looked at how long patients lived without their disease getting worse. The first study compared Revlimid with placebo, both taken with melphalan and prednisone. The second study compared Revlimid taken with low dose dexamethasone with standard treatment.

Two main studies have also been carried out involving a total of 353 patients with lower risk myelodysplastic syndromes. The first study did not compare Revlimid with any other treatment, while the second study compared it with placebo. The main measure of effectiveness was the number of patients who did not need a blood transfusion for at least 56 days in the first study and 182 days in the second study.

What benefit has Revlimid shown during the studies?

Revlimid was more effective than placebo at preventing a worsening of previously treated multiple myeloma. The results of the two studies taken together showed that, on average, it took 48.3 weeks for the disease to get worse in patients taking Revlimid, compared with 20.1 weeks in those taking placebo.

In the first study of newly diagnosed multiple myeloma, patients taking Revlimid (plus melphalan and prednisone) lived longer without their disease getting worse (27.4 months) than patients in the placebo group (14.3 month). In the second study, it took 26.4 months for the disease to get worse in patients taking Revlimid plus dexamethasone, compared with 22.7 months for those on standard treatment.

In patients with lower risk myelodysplastic syndromes, 97 out of 148 patients (66%) taking 10 mg Revlimid in the first study did not need a blood transfusion for at least 56 days. In the second study, 38 out of 69 patients (55%) taking 10 mg Revlimd did not need a blood transfusion for at least 182 days, compared with 4 out of 67 (6%) taking placebo.

What is the risk associated with Revlimid?

The most common side effects with Revlimid for the treatment of multiple myeloma are: fatigue (tiredness), neutropenia (low levels of neutrophils, a type of white blood cell), constipation, diarrhoea, muscle cramps, anaemia (low red blood cell counts), thrombocytopenia (low platelet counts), rash, back pain, insomnia, decreased appetite, cough, pyrexia (fever), peripheral oedema (swelling, specially of the ankles and feet), leucopenia (low white blood cell counts) and asthenia (weakness).The most common side effects with Revlimid for the treatment of myelodysplastic syndromes are: neutropenia, thrombocytopenia, diarrhoea, constipation, nausea (feeling sick), pruritus (itching) rash, fatigue (tiredness) and muscle spasms. The most serious side effects with Revlimid are: neutropenia, venous thromboembolism (problems due to the formation of blood clots in the veins), pneumonia (infection of the lungs), kidney failure, febrile neutropenia (neutropenia with fever) and anaemia. For the full list of all side effects reported with Revlimid, see the package leaflet.

Lenalidomide is expected to be harmful to the unborn child. Therefore, Revlimid must not be used in women who are pregnant. It must also 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. 

For the full list of restrictions, see the package leaflet.

Why has Revlimid been approved?

The CHMP decided that Revlimid’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 Revlimid?

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

The company that makes Revlimid 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 material and patient cards are provided to prescribers and patients.

The company has also set up a pregnancy prevention programme in each Member State and will collect information on whether the medicine is used outside its approved indication. The boxes containing Revlimid capsules also include a warning stating that lenalidomide is expected to be harmful to the unborn child.

In addition, the company will carry out a study in patients with myelodysplastic syndromes to gather further safety data, as well as a safety study in patients with newly diagnosed multiple myeloma not eligible for transplant.

Other information about Revlimid

The European Commission granted a marketing authorisation valid throughout the European Union for Revlimid on 14 June 2007.

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

Name Language First published Last updated
Revlimid : EPAR - Summary for the public BG = bălgarski 14/08/2008 30/03/2015
Revlimid : EPAR - Summary for the public ES = español 14/08/2008 30/03/2015
Revlimid : EPAR - Summary for the public CS = čeština 14/08/2008 30/03/2015
Revlimid : EPAR - Summary for the public DA = dansk 14/08/2008 30/03/2015
Revlimid : EPAR - Summary for the public DE = Deutsch 14/08/2008 30/03/2015
Revlimid : EPAR - Summary for the public ET = eesti keel 14/08/2008 30/03/2015
Revlimid : EPAR - Summary for the public EL = elliniká 14/08/2008 30/03/2015
Revlimid : EPAR - Summary for the public EN = English 14/08/2008 30/03/2015
Revlimid : EPAR - Summary for the public FR = français 14/08/2008 30/03/2015
Revlimid : EPAR - Summary for the public IT = italiano 14/08/2008 30/03/2015
Revlimid : EPAR - Summary for the public LV = latviešu valoda 14/08/2008 30/03/2015
Revlimid : EPAR - Summary for the public LT = lietuvių kalba 14/08/2008 30/03/2015
Revlimid : EPAR - Summary for the public HU = magyar 14/08/2008 30/03/2015
Revlimid : EPAR - Summary for the public MT = Malti 14/08/2008 30/03/2015
Revlimid : EPAR - Summary for the public NL = Nederlands 14/08/2008 30/03/2015
Revlimid : EPAR - Summary for the public PL = polski 14/08/2008 30/03/2015
Revlimid : EPAR - Summary for the public PT = português 14/08/2008 30/03/2015
Revlimid : EPAR - Summary for the public RO = română 14/08/2008 30/03/2015
Revlimid : EPAR - Summary for the public SK = slovenčina 14/08/2008 30/03/2015
Revlimid : EPAR - Summary for the public SL = slovenščina 14/08/2008 30/03/2015
Revlimid : EPAR - Summary for the public FI = suomi 14/08/2008 30/03/2015
Revlimid : EPAR - Summary for the public SV = svenska 14/08/2008 30/03/2015
Revlimid : EPAR - Summary for the public HR = Hrvatski 14/08/2008 30/03/2015

This EPAR was last updated on 30/03/2015 .

Authorisation details

Product details

Product details for Revlimid
NameRevlimid
Agency product numberEMEA/H/C/000717
Active substance

lenalidomide

International non-proprietary name (INN) or common name

lenalidomide

Therapeutic area Multiple Myeloma
Anatomical therapeutic chemical (ATC) code L04AX04
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 Revlimid
Marketing-authorisation holder

Celgene Europe Ltd

Revision24
Date of issue of marketing authorisation valid throughout the European Union14/06/2007

Contact address:

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

Product information

Product information

19/02/2015  Revlimid -EMEA/H/C/000717 -X-0073-G

Name Language First published Last updated
Revlimid : EPAR - Product Information HR = Hrvatski 29/10/2009 30/03/2015
Revlimid : EPAR - Product Information HR = Hrvatski 29/10/2009 30/03/2015
Revlimid : EPAR - Product Information HR = Hrvatski 29/10/2009 30/03/2015
Revlimid : EPAR - Product Information HR = Hrvatski 29/10/2009 30/03/2015
Revlimid : EPAR - Product Information HR = Hrvatski 29/10/2009 30/03/2015
Revlimid : EPAR - Product Information HR = Hrvatski 29/10/2009 30/03/2015
Revlimid : EPAR - Product Information HR = Hrvatski 29/10/2009 30/03/2015
Revlimid : EPAR - Product Information HR = Hrvatski 29/10/2009 30/03/2015
Revlimid : EPAR - Product Information HR = Hrvatski 29/10/2009 30/03/2015
Revlimid : EPAR - Product Information HR = Hrvatski 29/10/2009 30/03/2015
Revlimid : EPAR - Product Information HR = Hrvatski 29/10/2009 30/03/2015
Revlimid : EPAR - Product Information HR = Hrvatski 29/10/2009 30/03/2015
Revlimid : EPAR - Product Information HR = Hrvatski 29/10/2009 30/03/2015
Revlimid : EPAR - Product Information HR = Hrvatski 29/10/2009 30/03/2015
Revlimid : EPAR - Product Information HR = Hrvatski 29/10/2009 30/03/2015
Revlimid : EPAR - Product Information HR = Hrvatski 29/10/2009 30/03/2015
Revlimid : EPAR - Product Information HR = Hrvatski 29/10/2009 30/03/2015
Revlimid : EPAR - Product Information HR = Hrvatski 29/10/2009 30/03/2015
Revlimid : EPAR - Product Information HR = Hrvatski 29/10/2009 30/03/2015
Revlimid : EPAR - Product Information HR = Hrvatski 29/10/2009 30/03/2015
Revlimid : EPAR - Product Information HR = Hrvatski 29/10/2009 30/03/2015
Revlimid : EPAR - Product Information HR = Hrvatski 29/10/2009 30/03/2015
Revlimid : EPAR - Product Information HR = Hrvatski 29/10/2009 30/03/2015
Revlimid : EPAR - Product Information HR = Hrvatski 29/10/2009 30/03/2015
Revlimid : EPAR - Product Information HR = Hrvatski 29/10/2009 30/03/2015

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
Revlimid : EPAR - All Authorised presentations HR = Hrvatski 26/06/2007 30/03/2015
Revlimid : EPAR - All Authorised presentations HR = Hrvatski 26/06/2007 30/03/2015
Revlimid : EPAR - All Authorised presentations HR = Hrvatski 26/06/2007 30/03/2015
Revlimid : EPAR - All Authorised presentations HR = Hrvatski 26/06/2007 30/03/2015
Revlimid : EPAR - All Authorised presentations HR = Hrvatski 26/06/2007 30/03/2015
Revlimid : EPAR - All Authorised presentations HR = Hrvatski 26/06/2007 30/03/2015
Revlimid : EPAR - All Authorised presentations HR = Hrvatski 26/06/2007 30/03/2015
Revlimid : EPAR - All Authorised presentations HR = Hrvatski 26/06/2007 30/03/2015
Revlimid : EPAR - All Authorised presentations HR = Hrvatski 26/06/2007 30/03/2015
Revlimid : EPAR - All Authorised presentations HR = Hrvatski 26/06/2007 30/03/2015
Revlimid : EPAR - All Authorised presentations HR = Hrvatski 26/06/2007 30/03/2015
Revlimid : EPAR - All Authorised presentations HR = Hrvatski 26/06/2007 30/03/2015
Revlimid : EPAR - All Authorised presentations HR = Hrvatski 26/06/2007 30/03/2015
Revlimid : EPAR - All Authorised presentations HR = Hrvatski 26/06/2007 30/03/2015
Revlimid : EPAR - All Authorised presentations HR = Hrvatski 26/06/2007 30/03/2015
Revlimid : EPAR - All Authorised presentations HR = Hrvatski 26/06/2007 30/03/2015
Revlimid : EPAR - All Authorised presentations HR = Hrvatski 26/06/2007 30/03/2015
Revlimid : EPAR - All Authorised presentations HR = Hrvatski 26/06/2007 30/03/2015
Revlimid : EPAR - All Authorised presentations HR = Hrvatski 26/06/2007 30/03/2015
Revlimid : EPAR - All Authorised presentations HR = Hrvatski 26/06/2007 30/03/2015
Revlimid : EPAR - All Authorised presentations HR = Hrvatski 26/06/2007 30/03/2015
Revlimid : EPAR - All Authorised presentations HR = Hrvatski 26/06/2007 30/03/2015
Revlimid : EPAR - All Authorised presentations HR = Hrvatski 26/06/2007 30/03/2015
Revlimid : EPAR - All Authorised presentations HR = Hrvatski 26/06/2007 30/03/2015
Revlimid : EPAR - All Authorised presentations HR = Hrvatski 26/06/2007 30/03/2015

Name Language First published Last updated
Revlimid : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 14/08/2008 21/01/2011
Revlimid : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 14/08/2008 21/01/2011
Revlimid : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 14/08/2008 21/01/2011
Revlimid : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 14/08/2008 21/01/2011
Revlimid : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 14/08/2008 21/01/2011
Revlimid : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 14/08/2008 21/01/2011
Revlimid : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 14/08/2008 21/01/2011
Revlimid : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 14/08/2008 21/01/2011
Revlimid : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 14/08/2008 21/01/2011
Revlimid : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 14/08/2008 21/01/2011
Revlimid : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 14/08/2008 21/01/2011
Revlimid : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 14/08/2008 21/01/2011
Revlimid : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 14/08/2008 21/01/2011
Revlimid : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 14/08/2008 21/01/2011
Revlimid : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 14/08/2008 21/01/2011
Revlimid : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 14/08/2008 21/01/2011
Revlimid : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 14/08/2008 21/01/2011
Revlimid : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 14/08/2008 21/01/2011
Revlimid : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 14/08/2008 21/01/2011
Revlimid : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 14/08/2008 21/01/2011
Revlimid : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 14/08/2008 21/01/2011
Revlimid : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 14/08/2008 21/01/2011
Revlimid : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 14/08/2008 21/01/2011
Revlimid : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 14/08/2008 21/01/2011

Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

Multiple myeloma

Revlimid is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant (see section 4.2).

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

Myelodysplastic syndromes

Revlimid is indicated for the treatment of patients with transfusion-dependent anaemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Revlimid : EPAR - Procedural steps taken before authorisation HR = Hrvatski 26/06/2007  
Revlimid : EPAR - Scientific Discussion HR = Hrvatski 26/06/2007  

Authorised

This medicine is approved for use in the European Union

More information on Revlimid