Lenalidomide
Also known as: Revlimid · Lenalidomide Accord · Lenalidomide Mylan · Lenalidomide Krka (previously Lenalidomide Krka d.d. Novo mesto) · Lenalidomide Krka d.d. Novo mesto (previously Lenalidomide Krka)
General information only. Anpheros does not diagnose and does not recommend treatment. Talk to a doctor or pharmacist about your situation. In an emergency, call 112 (or your local emergency number).
In short
In the European Union, lenalidomide is indicated as monotherapy for the maintenance treatment of adults with newly diagnosed multiple myeloma after autologous stem cell transplantation, as combination therapy for previously untreated multiple myeloma in adults ineligible for transplant, and in combination with dexamethasone for adults who have received at least one prior therapy. In the United States, lenalidomide is indicated in combination with dexamethasone for adult patients with multiple myeloma, and as maintenance therapy following autologous hematopoietic stem cell transplantation. Lenalidomide is also indicated for transfusion-dependent anemia due to specific low- or intermediate-1-risk myelodysplastic syndromes, and it is listed by the cited source as having an approved use for myelodysplastic syndromes. Additionally, it is indicated for the treatment of adult patients with mantle cell lymphoma, follicular lymphoma, and, in the United States, marginal zone lymphoma.
From: Source: European Medicines Agency (EMA), Revlimid — EPAR, 09/09/2025. © European Medicines Agency. · Data provided by the U.S. Food and Drug Administration. · Source: European Medicines Agency (EMA) — EPAR. © European Medicines Agency.
AI-generated summary of the sources cited on this page, checked automatically against them. Not reviewed by a clinician; not medical advice.
Codes
- RxNorm
- 342369 lenalidomide
- EMA
- EMEA/H/C/000717, EMEA/H/C/004857, EMEA/H/C/005306, EMEA/H/C/005348, EMEA/H/C/005734
Official indications
Quoted unchanged from official product information, in English. Listed alphabetically by product, not ranked.
FDA (USA) Lenalidomide
1 INDICATIONS AND USAGE Lenalidomide is a thalidomide analogue indicated for the treatment of adult patients with: Multiple myeloma (MM), in combination with dexamethasone ( 1.1 ). MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT) ( 1.1 ). Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities ( 1.2 ). Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib ( 1.3 ). Previously treated marginal zone lymphoma (MZL), in combination with a rituximab product ( 1.5 ). Previously treated follicular lymphoma (FL), in combination with a rituximab product ( 1.4 ). Limitations of Use: Lenalidomide capsules are not indicated and are not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials ( 1.6 ). 1.1 Multiple Myeloma Lenalidomide capsules in combination with dexamethasone are indicated for the treatment of adult patients with multiple myeloma (MM). Lenalidomide capsules are indicated as maintenance therapy in adult patients with MM following autologous hematopoietic stem cell transplantation (auto-HSCT). 1.2 Myelodysplastic Syndromes Lenalidomide capsules are indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. 1.3 Mantle Cell Lymphoma Lenalidomide capsules are indicated for the treatment of adult patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. 1.4 Follicular Lymphoma Lenalidomide capsules in combination with a rituximab product, are indicated for the treatment of adult patients with previously treated follicular lymphoma (FL). 1.5 Marginal Zone Lymphoma Lenalidomide capsules in combination with a rituximab product, are indicated for the treatment of adult patients with previously treated marginal zone lymphoma (MZL). 1.6 Limitations of Use Lenalidomide capsules are not indicated and are not recommended for the treatment of patients with CLL outside of controlled clinical trials [see Warnings and Precautions ( 5.5 )] .
Data provided by the U.S. Food and Drug Administration.
Document date: 20260527 · Official document →
EMA (EU) Revlimid
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).
Source: European Medicines Agency (EMA), Revlimid — EPAR, 09/09/2025. © European Medicines Agency.
Document date: 09/09/2025 · Official document →
Related terms in the cited sources
Has an official indication for
- Myelodysplastic Syndromes Condition
In alphabetical order.
Other treatments A–Z
What people report
Not enough data yet. Anonymous counts appear here only for groups of at least 20 people who agreed to share them.
External resources
Questions
What is Lenalidomide approved for in the European Union?
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). (Source: European Medicines Agency (EMA), Revlimid — EPAR, 09/09/2025. © European Medicines Agency.)
Sources and attribution
- Source: European Medicines Agency (EMA) — EPAR. © European Medicines Agency.
- Names other than the official source titles: Anpheros translations and plain-language names, made with AI assistance and checked automatically; the source names are in English.
- Data provided by the U.S. Food and Drug Administration.
- This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product.
- Source: European Medicines Agency (EMA), Revlimid — EPAR, 09/09/2025. © European Medicines Agency.
Anpheros Search catalog 2026.10.5, published 17 October 2026. About the data →
About this page. This page brings together public information from official sources, each cited where it is used. It is not medical advice, it is not a diagnosis, and it does not tell you which treatment to take.
Treatments. Indications are quoted unchanged from official product information (European Medicines Agency, U.S. Food and Drug Administration). They describe what a medicine is approved for, not whether it is right for you. Approved uses can differ between countries. Always read the package leaflet and follow your doctor's or pharmacist's advice.
What people report. Figures marked "reported by Anpheros users" are anonymous counts from at least 20 people who agreed to share them. They show what people report, not what works, and they are not clinical evidence.
Links between terms. "May be associated with" means the link appears in a cited source. It does not mean you have that condition.
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