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LENALIDOMIDE
LENALIDOMIDE is a Thalidomide Analog [EPC] drug. It is currently FDA-approved (first approved 2005).
Lenalidomide is a small molecule inhibitor of the CRL4(CRBN) E3 ubiquitin ligase. It is used to treat conditions such as relapsed or refractory multiple myeloma, multiple myeloma, and diffuse large B-cell lymphoma.
At a glance
| Generic name | LENALIDOMIDE |
|---|---|
| Drug class | Thalidomide Analog [EPC] |
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 2005 |
Approved indications
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
- Diarrhea
- Anemia
- Constipation
- Peripheral edema
- Neutropenia
- Fatigue
- Back pain
- Nausea
- Asthenia
- Insomnia
- Infection
- Thrombocytopenia
Serious adverse events
- Infection
- DVT
- Pneumonia
- Thrombocytopenia
- Neutropenia
- Asthenia
- Fatigue
- Anemia
- Dyspnea
- Hyperglycemia
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)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- LENALIDOMIDE CI brief — competitive landscape report
- LENALIDOMIDE updates RSS · CI watch RSS
Frequently asked questions about LENALIDOMIDE
What is LENALIDOMIDE?
LENALIDOMIDE is a Thalidomide Analog [EPC] drug.
What drug class is LENALIDOMIDE in?
LENALIDOMIDE belongs to the Thalidomide Analog [EPC] class. See all Thalidomide Analog [EPC] drugs at /class/thalidomide-analog-epc.
When was LENALIDOMIDE approved?
LENALIDOMIDE was first approved on 2005.
What development phase is LENALIDOMIDE in?
LENALIDOMIDE is FDA-approved (marketed).
What are the side effects of LENALIDOMIDE?
Common side effects of LENALIDOMIDE include Diarrhea, Anemia, Constipation, Peripheral edema, Neutropenia, Fatigue. Serious adverse events: Infection, DVT, Pneumonia, Thrombocytopenia.
Related
- Drug class: All Thalidomide Analog [EPC] drugs
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing