Lenalidomide Krka d.d.
lenalidomide
Table of contents
Overview
Lenalidomide Krka d.d. is a medicine used for the treatment of certain cancers and serious conditions affecting blood cells and bone marrow, namely multiple myeloma, myelodysplastic syndromes and follicular lymphoma.
In multiple myeloma, a cancer of a type of white blood cells called plasma cells, Lenalidomide Krka d.d. 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 myelodysplastic syndromes, a group of bone marrow disorders that cause anaemia (low red blood cell counts), Lenalidomide Krka d.d. is used in patients who need blood transfusions to manage their anaemia. It is used in patients with a genetic change (called deletion 5q) when other treatments are not adequate.
In follicular lymphoma, a blood cancer that affects a type of white blood cell called B lymphocytes, Lenalidomide Krka d.d. 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. contains the active substance lenalidomide and is a ‘generic medicine’. This means that Lenalidomide Krka d.d. contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Revlimid.
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Lenalidomide Krka d.d. : EPAR - Medicine overview (PDF/174.28 KB)
First published: 18/02/2021
EMA/11795/2021 -
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Lenalidomide Krka d.d. : EPAR - Risk-management-plan summary (PDF/258.04 KB)
First published: 18/02/2021
Authorisation details
| Product details | |
|---|---|
| Name |
Lenalidomide Krka d.d.
|
| Agency product number |
EMEA/H/C/005729
|
| Active substance |
lenalidomide hydrochloride hydrate
|
| International non-proprietary name (INN) or common name |
lenalidomide
|
| Therapeutic area (MeSH) |
|
| Anatomical therapeutic chemical (ATC) code |
L04AX04
|
Generic |
This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines. |
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Krka, d.d., Novo mesto
|
| Revision |
2
|
| Date of issue of marketing authorisation valid throughout the European Union |
11/02/2021
|
| Contact address |
Krka, d.d., Novo mesto |
Product information
13/12/2021 Lenalidomide Krka d.d. - EMEA/H/C/005729 - IB/0003
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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Immunosuppressants
Therapeutic indication
Multiple myeloma
Lenalidomide Krka d.d. 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. 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. 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
Lenalidomide Krka d.d. as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia 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.
Follicular lymphoma
Lenalidomide Krka d.d. in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 – 3a).