Basic Information
Revlimid
Regulatory Information
EMEA/H/C/000717
June 14, 2007
52
January 8, 2024
Company Information
Ireland
Plaza 254 Blanchardstown Corporate Park 2 Dublin 15 D15 T867
Bristol-Myers Squibb Pharma EEIG
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication **Multiple myeloma** Revlimid as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. Revlimid 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. Revlimid 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** Revlimid 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** Revlimid as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma. **Follicular lymphoma** Revlimid in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 – 3a).
Overview Summary
Revlimid 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 mantle cell and follicular lymphoma. In **multiple myeloma**, a cancer of a type of white blood cells called plasma cells, Revlimid is used: - in adults who have had a stem cell transplant (a procedure where the patient’s bone marrow is cleared of cells and replaced by stem cells from a donor); - in adults with previously untreated (newly diagnosed) 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), Revlimid is used in patients who need blood transfusions to manage their anaemia. It is used in patients with a genetic abnormality (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, Revlimid is used in adults whose disease has come back after treatment or does not improve with treatment. In follicular lymphoma it is used with the medicine rituximab. Revlimid contains the active substance lenalidomide.