Revlimid

lenalidomide

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

What is Revlimid used for?

Revlimid is an anticancer medicine. It is used in combination with dexamethasone (an anti-inflammatory medicine) to treat adults with multiple myeloma whose disease has been treated at least once in the past. Multiple myeloma is a cancer of the plasma cells in the bone marrow.

Because the number of patients with multiple myeloma is low, the disease is considered ‘rare’, and Revlimid was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 12 December 2003.

The medicine can only be obtained with a prescription.

How is Revlimid used?

Treatment with Revlimid must be initiated and monitored by doctors who have experience in the management of multiple myeloma.

Revlimid is taken in repeated 28-day cycles: the patient takes the medicine once a day for 21 days, followed by seven days off the medicine. Dexamethasone should be taken at a dose of 40 mg once a day on days 1 to 4, 9 to 12 and 17 to 20 of the first four cycles, and on days 1 to 4 thereafter.

The recommended dose of Revlimid is 25 mg a day. This dose 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).

Revlimid should be taken at around the same time each day.

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 in multiple myeloma: 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 cancerous cells.

How has Revlimid been studied?

Revlimid was studied in two main studies involving 704 patients with 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.

What benefit has Revlimid shown during the studies?

Revlimid was more effective than placebo at preventing a worsening of 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.

What is the risk associated with Revlimid?

The most common side effects with Revlimid are fatigue (tiredness; 43.9%), neutropenia (low white-blood-cell count; 42.2%), constipation (40.5%), diarrhoea (38.5%), muscle cramp (33.4%), anaemia (low red-blood-cell counts; 31.4%), thrombocytopenia (low platelet counts; 21.5%), and rash (21.2%). The most serious side effects were neutropenia and venous thromboembolism (problems due to the formation of blood clots in the veins). 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. Revlimid must not be used by people who are hypersensitive (allergic) to lenalidomide or any of the other ingredients. For the full list of restrictions, see the package leaflet.

Why has Revlimid been approved?

The CHMP decided that, in combination with dexamethasone, 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 use of Revlimid?

The company that makes Revlimid will provide a letter and educational kits for healthcare workers, and brochures for patients, explaining the fact that it 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 pregnancy-prevention programme in each Member State and 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.

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.

This EPAR was last updated on 25/01/2013 .

More detail is available in the summary of product characteristics

Product details

Publication details

Product information

17/01/2013  Revlimid -EMEA/H/C/000717 -II/0060

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.

Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

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

Changes since initial authorisation of medicine

Initial marketing-authorisation documents