Revlimid - lenalidomide

What is Revlimid?

Revlimid is a medicine containing the active substance lenalidomide. It is available as capsules (white: 5 mg; blue-green and yellow: 10 mg; blue and white: 15 mg; white: 25 mg).

What is Revlimid used for?

Revlimid is an anticancer medicine indicated, in combination with dexamethasone (an anti-inflammatory drug), for the treatment of adult patients with multiple myeloma who have undergone at least one previous therapy. Multiple myeloma is a tumor of plasma cells present 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?

Revlimid therapy should be started and monitored by physicians experienced in the treatment of multiple myeloma.

Revlimid should be taken in repeated cycles of 28 days: the patient should take the drug once a day for 21 days and then stop taking it for seven days. Dexamethasone should be taken at a dose of 40 mg once a day on days 1 to 4, from 9 to 12 and from 17 to 20 for the first 4 cycles and subsequently on days 1 to 4.

The recommended dose of Revlimid is 25 mg a day. This dosage will have to be reduced or the treatment will have to be stopped depending on the patient's condition and platelet levels (constituents of the blood that promote coagulation) and neutrophils (a type of white blood cell). A lower dose should also be used in patients with moderate or severe kidney problems. For more information, see the summary of product characteristics, also included with the EPAR.

Revlimid should be taken at about the same time every day. The capsules should be swallowed whole, preferably with water.

How does Revlimid work?

The active ingredient contained in Revlimid, lenalidomide, is an immunomodulatory agent, which affects the activity of the immune system (the body's natural defense system). Lenalidomide acts in various ways in multiple myeloma: it blocks the development of cancer cells, prevents the growth of blood vessels in tumors and also stimulates certain cells of the immune system to attack cancer cells.

How has Revlimid been studied?

The effects of Revlimid were first tested in experimental models before being studied in humans.

Revlimid has been studied in two main studies involving 704 patients with multiple myeloma. In both studies Revlimid was compared with placebo (a dummy treatment), in combination in both cases with dexamethasone. The main measure of effectiveness was how long the illness lasted.

What benefit has Revlimid shown during the studies?

Revlimid was more effective than placebo in preventing a worsening of multiple myeloma. Considering the results of the two studies together, it emerges that, on average, the patients who took Revlimid worsened after 48.3 weeks compared to 20.1 weeks of placebo-treated patients.

What is the risk associated with Revlimid?

The most common side effects with Revlimid (seen in more than 1 patient in 10) are neutropenia (decreased number of neutrophils), fatigue, asthenia (weakness), constipation, muscle cramps, thrombocytopenia (decreased number of platelets), anemia ( decrease in the number of red blood cells), diarrhea and rash (rash). For the full list of all side effects reported with Revlimid, see the Package Leaflet.

Lenalidomide is thought to be harmful to an unborn baby. Therefore, Revlimid should not be used in pregnant women. It must also not be taken by women of childbearing age, unless they take all necessary measures to avoid pregnancy before treatment, during treatment and shortly after finishing it. Revlimid should not be used in people who may be hypersensitive (allergic) to lenalidomide or any of the other substances. For the full list of usage restrictions, see the package leaflet.

Why has Revlimid been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Revlimid's benefits, in combination with dexamethasone, outweigh its risks for the treatment of patients with multiple myeloma who have undergone at least one previous therapy. The Committee recommended that Revlimid be given marketing authorization.

What measures are being taken to ensure the safe use of Revlimid?

The Revlimid company will provide a letter and information kits for healthcare professionals as well as leaflets for patients explaining that it is expected to be harmful to the fetus and explains in detail all that needs to be done to use the drug safely. . In addition, it will make special cards available for patients to ensure that each patient takes all the necessary safety measures. Each Member State must ensure that information material and patient records are provided to physicians and patients.

The company must also implement a pregnancy prevention program in each Member State and collect information on the possible use of the drug outside the authorized indication. The packs containing Revlimid capsules also report a warning indicating that lenalidomide is believed to be harmful to an unborn baby.