FDA label

What is Revlimid used for?

Revlimid contains lenalidomide. The FDA-approved uses below are 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 Revlimid lists 5 uses: Multiple Myeloma; Myelodysplastic Syndromes; Mantle Cell Lymphoma; Follicular Lymphoma; and 1 more.

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Revlimid, capsule

Indications and Usage, quoted from the label by Celgene Corporation (NDA021880). Cross-references to other label sections are left out.

Multiple Myeloma

REVLIMID in combination with dexamethasone is indicated for the treatment of adult patients with multiple myeloma (MM).

REVLIMID is indicated as maintenance therapy in adult patients with MM following autologous hematopoietic stem cell transplantation (auto-HSCT).

Myelodysplastic Syndromes

REVLIMID is 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

REVLIMID is 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

REVLIMID in combination with a rituximab product, is indicated for the treatment of adult patients with previously treated follicular lymphoma (FL).

Marginal Zone Lymphoma

REVLIMID in combination with a rituximab product, is indicated for the treatment of adult patients with previously treated marginal zone lymphoma (MZL).

Limitations of Use

REVLIMID is not indicated and is not recommended for the treatment of patients with CLL outside of controlled clinical trials.

Source: DailyMed label, set id 5fa97bf5-28a2-48f1-8955-f56012d296be, version 41, effective March 24, 2023. NDC 59572-402, one of 6 listings for this product.

Questions

What is Revlimid used for?

The FDA label for Revlimid lists 5 uses: Multiple Myeloma; Myelodysplastic Syndromes; Mantle Cell Lymphoma; Follicular Lymphoma; and 1 more.

What drug class is Revlimid?

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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