Lenalidomide Krka d.d. Novo mesto (previously Lenalidomide Krka)
Authorised
This medicine is authorised for use in the European Union
lenalidomide
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Lenalidomide Krka d.d. Novo mesto is a medicine used for the treatment of certain cancers affecting blood cells, namely multiple myeloma and follicular lymphoma.
In multiple myeloma, a cancer of a type of white blood cells called plasma cells, Lenalidomide Krka d.d. Novo mesto is used:
- in adults with previously untreated (newly diagnosed) multiple myeloma, who have had an autologous stem cell transplant (a procedure where the patient’s bone marrow is cleared of cells and replaced with the patient’s own stem cells to form new bone marrow);
- in adults with previously untreated multiple myeloma, who cannot have stem cell transplantation. It is used in combination with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone;
- in adults whose disease has been treated at least once. It is used in combination with dexamethasone.
In follicular lymphoma, a blood cancer that affects a type of white blood cell called B lymphocytes, Lenalidomide Krka d.d. Novo mesto. Lenalidomide Krka d.d. Novo mesto is used in adults whose disease has come back after treatment or does not improve with treatment. It is used in combination with rituximab.
Lenalidomide Krka d.d. Novo mesto contains the active substance lenalidomide and is a ‘generic medicine’. This means that Lenalidomide Krka d.d. Novo mesto contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Revlimid. For more information on generic medicines, see the question-and-answer document below.
Lenalidomide Krka d.d. Novo mesto can only be obtained with a prescription and treatment should be supervised by doctors who have experience in the use of cancer medicines.
Lenalidomide Krka d.d. Novo mesto is available as capsules of various strengths to be taken by mouth. Treatment is given in cycles, with the medicine 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 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 Krka d.d. Novo mesto, see the package leaflet or contact your doctor or pharmacist.
The active substance in Lenalidomide Krka d.d. Novo mesto, 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 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 Krka d.d. Novo mesto.
As for every medicine, the company provided studies on the quality of Lenalidomide Krka d.d. Novo mesto. The company also carried out studies 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 Krka d.d. Novo mesto 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 Krka d.d. Novo mesto has been shown to have comparable quality and to be bioequivalent to Revlimid. Therefore, the Agency’s view was that, as for Revlimid, the benefits of Lenalidomide Krka d.d. Novo mesto outweigh the identified risks and it can be authorised for use in the EU.
The company that markets Lenalidomide Krka d.d. Novo mesto will provide 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 and will collect information on the medicine’s use outside its authorised uses. The boxes containing Lenalidomide Krka d.d. Novo mesto 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 Krka d.d. Novo mesto have also been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Lenalidomide Krka d.d. Novo mesto are continuously monitored. Side effects reported with Lenalidomide Krka d.d. Novo mesto are carefully evaluated and any necessary action taken to protect patients.
Lenalidomide Krka d.d. Novo mesto received a marketing authorisation valid throughout the EU on 11 February 2021.
Product information
Latest procedure affecting product information:
IB/0004
13/12/2021
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Lenalidomide Krka d.d. Novo mesto (previously Lenalidomide Krka)
- Active substance
- lenalidomide hydrochloride monohydrate
- International non-proprietary name (INN) or common name
- lenalidomide
- Therapeutic area (MeSH)
- Multiple Myeloma
- Lymphoma, Follicular
- Anatomical therapeutic chemical (ATC) code
- L04AX04
Pharmacotherapeutic group
ImmunosuppressantsTherapeutic indication
Multiple myeloma
Lenalidomide krka d.d. Novo mesto as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation.
Lenalidomide krka d.d. Novo mesto as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4.2) is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.
Lenalidomide krka d.d. Novo mesto in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.
Follicular lymphoma
Lenalidomide krka d.d. Novo mesto in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 – 3a).
Multiple myeloma
Lenalidomide krka d.d. Novo mesto as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation.
Lenalidomide krka d.d. Novo mesto as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4.2) is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.
Lenalidomide krka d.d. Novo mesto in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.
Follicular lymphoma
Lenalidomide krka d.d. Novo mesto in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 – 3a).
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