Lenalidomide Accord

Lenalidomide Accord is available as capsules of various strengths to be taken by mouth. The medicine can only be obtained with a prescription and treatment must be monitored by doctors who have experience in the use of cancer medicines.

Treatment is given in cycles, with Lenalidomide Accord being used once a day on certain days of the cycles. Treatment cycles are continued until the disease is no longer being controlled or side effects become unacceptable. The dose of Lenalidomide Accord depends on the disease it is being used for, the patient’s overall health and blood test results. The dose may need to be reduced or treatment interrupted in case of certain side effects.

For more information about using Lenalidomide Accord, see the package leaflet or contact your doctor or pharmacist.

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

Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Revlimid, and do not need to be repeated for Lenalidomide Accord.

As for every medicine, the company provided studies on the quality of Lenalidomide Accord. The company also carried out a study that showed that it is ‘bioequivalent’ to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

Because Lenalidomide Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.

The European Medicines Agency concluded that, in accordance with EU requirements, Lenalidomide Accord has been shown to have comparable quality and to be bioequivalent to Revlimid. Therefore, the Agency’s view was that, as for Revlimid, the benefit of Lenalidomide Accord outweighs the identified risk and it can be authorised for use in the EU.

The company that markets Lenalidomide Accord will provide a letter and educational kits for healthcare professionals, and brochures for patients, explaining that the medicine can 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 to patients about the safety measures patients should take.

The company has also set up a pregnancy prevention programme in each Member State and will collect information on the medicine’s use outside its authorised uses. The boxes containing Lenalidomide Accord capsules also include a warning stating that lenalidomide can be harmful to the unborn child.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lenalidomide Accord have also been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Lenalidomide Accord are continuously monitored. Side effects reported with Lenalidomide Accord are carefully evaluated and any necessary action taken to protect patients.

Lenalidomide Accord received a marketing authorisation valid throughout the EU on 20 September 2018.