FDA label
What is lenalidomide used for?
The FDA-approved uses of lenalidomide, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label for lenalidomide lists 5 uses: Multiple Myeloma; Myelodysplastic Syndromes; Mantle Cell Lymphoma; Follicular Lymphoma; and 1 more.
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Lenalidomide, capsule
Indications and Usage, quoted from the label by Teva Pharmaceuticals, Inc. (ANDA201452). Cross-references to other label sections are left out.
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).
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.
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.
Follicular Lymphoma
Lenalidomide capsules in combination with a rituximab product, are indicated for the treatment of adult patients with previously treated follicular lymphoma (FL).
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).
Limitations of Use
Lenalidomide capsules are not indicated and are not recommended for the treatment of patients with CLL outside of controlled clinical trials.
Source: DailyMed label, set id 1b2716cf-24b4-4157-a218-58ede63917bd, version 6, effective May 27, 2026. NDC 0480-1241, one of 108 listings for this product.
Questions
What is lenalidomide used for?
The FDA label for lenalidomide lists 5 uses: Multiple Myeloma; Myelodysplastic Syndromes; Mantle Cell Lymphoma; Follicular Lymphoma; and 1 more.
What drug class is lenalidomide?
FDA lists lenalidomide in the Thalidomide Analog established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
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