Lenalidomide Krka is a medicine used for the treatment of certain cancers and serious conditions affecting blood cells and bone marrow, namely multiple myeloma, myelodysplastic syndromes, mantle cell lymphoma and follicular lymphoma. In multiple myeloma, a cancer of a type of white blood cells called plasma cells, Lenalidomide Krka 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 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 mantle cell lymphoma and follicular lymphoma, blood cancers that affect a type of white blood cell called B lymphocytes, Lenalidomide Krka is used in adults whose disease has come back after treatment or does not improve with treatment. In follicular lymphoma it is used in combination with rituximab. Lenalidomide Krka contains the active substance lenalidomide and is a ‘generic medicine’. This means that Lenalidomide Krka 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.
Therapeutic Indication
**Multiple myeloma** Lenalidomide Krka 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 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 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 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. Mantle cell lymphoma Lenalidomide Krka as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (see sections 4\.4 and 5\.1\). **Follicular lymphoma** Lenalidomide Krka 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 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 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 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 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. **Mantle cell lymphoma** Lenalidomide Krka as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (see sections 4\.4 and 5\.1\). **Follicular lymphoma** Lenalidomide Krka in combination with rituximab (anti\-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 – 3a).
Therapeutic Area (MeSH)
ATC Code
L04AX04
ATC Item
N/A
Pharmacotherapeutic Group
Immunosuppressants
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| lenalidomide hydrochloride monohydrate | N/A | lenalidomide hydrochloride monohydrate |
EMA Name
Lenalidomide Krka (previously Lenalidomide Krka d.d. Novo mesto)
Medicine Name
Lenalidomide Krka (previously Lenalidomide Krka d.d. Novo mesto)
Aliases
N/ANo risk management plan link.
