Last reviewed 2026-04-20 · How we verify

Revlimid (lenalidomide)

Lenalidomide targets cereblon to degrade substrate proteins, inducing cytotoxicity and immunomodulation.

Lenalidomide is a thalidomide analogue indicated for multiple myeloma (with dexamethasone), del(5q) myelodysplastic syndromes, and relapsed/refractory mantle cell lymphoma. It targets cereblon to induce cytotoxicity and immunomodulation through protein degradation and T-cell/NK-cell activation. Major risks include severe teratogenicity (contraindicated in pregnancy), thrombosis, and severe hypersensitivity reactions. The drug has favorable pharmacokinetics with renal elimination and limited drug interactions, though dose adjustment is needed in renal impairment.

At a glance

Mechanism of action

Lenalidomide is a thalidomide analogue that mediates cellular activities through cereblon, a component of a cullin ring E3 ubiquitin ligase enzyme complex. In the presence of the drug, substrate proteins including Aiolos, Ikaros, and CK1α are targeted for ubiquitination and subsequent degradation, leading to direct cytotoxic and immunomodulatory effects. Lenalidomide inhibits proliferation and induces apoptosis of hematopoietic tumor cells including multiple myeloma, mantle cell lymphoma, and del(5q) myelodysplastic syndromes. The immunomodulatory properties include increased number and activation of T cells and natural killer cells, leading to enhanced antibody-dependent cell-mediated cytotoxicity through increased secretion of interleukin-2 and interferon-gamma, increased NKT cells, and inhibition of pro-inflammatory cytokines such as TNF-α and IL-6 by monocytes. In multiple myeloma cells, lenalidomide combined with dexamethasone synergizes the inhibition of cell proliferation and induction of apoptosis.

Approved indications

• Follicular lymphoma
• Mantle cell lymphoma
• Marginal zone lymphoma
• Multiple myeloma
• Myelodysplastic syndrome

Boxed warnings

• WARNING: EMBRYO-FETAL TOXICITY, HEMATOLOGIC TOXICITY, and VENOUS and ARTERIAL THROMBOEMBOLISM Embryo-Fetal Toxicity Do not use lenalidomide capsules during pregnancy. Lenalidomide, a thalidomide analogue, caused limb abnormalities in a developmental monkey study. Thalidomide is a known human teratogen that causes severe life-threatening human birth defects. If lenalidomide is used during pregnancy, it may cause birth defects or embryo-fetal death. In females of reproductive potential, obtain 2 negative pregnancy tests before starting lenalidomide treatment. Females of reproductive potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after lenalidomide capsules treatment [see Warnings and Precautions ( 5.1 ), and Medication Guide ( 17 )] . To avoid embryo-fetal exposure to lenalidomide, lenalidomide capsules are only available through a restricted distribution program, the Lenalidomide REMS program ( 5.2 ). Information about the Lenalidomide REMS program is available at www.lenalidomiderems.com or by calling the REMS Call Center at 1-888-423-5436. Hematologic Toxicity (Neutropenia and Thrombocytopenia) Lenalidomide capsules can cause significant neutropenia and thrombocytopenia. Eighty percent of patients with del 5q myelodysplastic syndromes had to have a dose delay/reduction during the major study. Thirty-four percent of patients had to have a second dose delay/reduction. Grade 3 or 4 hematologic toxicity was seen in 80% of patients enrolled in the study. Patients on therapy for del 5q myelodysplastic syndromes should have their complete blood counts monitored weekly for the first 8 weeks of therapy and at least monthly thereafter. Patients may require dose interruption and/or reduction. Patients may require use of blood product support and/or growth factors [see Dosage and Administration ( 2.2 )] . Venous and Arterial Thromboembolism Lenalidomide capsules have demonstrated a significantly increased risk of deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as risk of myocardial infarction and stroke in patients with multiple myeloma who were treated with lenalidomide capsules and dexamethasone therapy. Monitor for and advise patients about signs and symptoms of thromboembolism. Advise patients to seek immediate medical care if they develop symptoms such as shortness of breath, chest pain, or arm or leg swelling. Thromboprophylaxis is recommended and the choice of regimen should be based on an assessment of the patient’s underlying risks [see Warnings and Precautions ( 5.4 )] . WARNING: EMBRYO-FETAL TOXICITY, HEMATOLOGIC TOXICITY, and VENOUS and ARTERIAL THROMBOEMBOLISM See full prescribing information for complete boxed warning. EMBRYO-FETAL TOXICITY Lenalidomide, a thalidomide analogue, caused limb abnormalities in a developmental monkey study similar to birth defects caused by thalidomide in humans. If lenalidomide is used during pregnancy, it may cause birth defects or embryo-fetal death. Pregnancy must be excluded before start of treatment. Prevent pregnancy during treatment by the use of two reliable methods of contraception ( 5.1 ). Lenalidomide capsules are available only through a restricted distribution program, called the Lenalidomide REMS program ( 5.2 , 17 ). HEMATOLOGIC TOXICITY . Lenalidomide capsules can cause significant neutropenia and thrombocytopenia ( 5.3 ). VENOUS AND ARTERIAL THROMBOEMBOLISM Significantly increased risk of deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as risk of myocardial infarction and stroke in patients with multiple myeloma receiving lenalidomide capsules with dexamethasone. Anti-thrombotic prophylaxis is recommended ( 5.4 ).

Common side effects

• lymphopenia
• hypocalcemia
• thrombocytopenia
• hyperglycemia
• anemia
• diarhhea
• hypoalbuminemia
• increased creatinine
• hyponatremia
• Fatigue
• Oedema peripheral
• hypoglycemia

Drug interactions

• Digoxin
• Erythropoietin stimulating agents
• Estrogen-containing therapies
• Warfarin

Key clinical trials

• A Study of Glofitamab and Lenalidomide in People With Mantle Cell Lymphoma (PHASE1)
• Fixed Duration vs Continuous Daratumumab in Transplant Ineligible Older Adults With Newly Diagnosed Multiple Myeloma (PHASE3)
• Comparing the Combination of Selinexor-Daratumumab-Velcade-Dexamethasone (Dara-SVD) With the Usual Treatment (Dara-RVD) for High-Risk Newly Diagnosed Multiple Myeloma (PHASE2)
• Testing the Addition of an Anti-cancer Drug, Lenalidomide, to the Usual Combination Chemotherapy Treatment ("EPOCH") for Adult T-Cell Leukemia-Lymphoma (ATLL) (PHASE1)
• Lenalidomide and Dinutuximab With or Without Isotretinoin in Treating Younger Patients With Refractory or Recurrent Neuroblastoma (PHASE1)
• Lenalidomide, Ibrutinib, and Rituximab in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma That Is Metastatic or Cannot Be Removed by Surgery (PHASE1)
• Testing the Combination of Anti-cancer Drugs Mosunetuzumab, Polatuzumab Vedotin, and Lenalidomide for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma (PHASE1)
• Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed/Refractory B-cell Lymphoma (PHASE1,PHASE2)

Patents

Primary sources

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