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Lenalidomide

    DEA Class; Rx

    Common Brand Names; Revlimid

    • Antineoplastics, Angiogenesis Inhibitor

    Biologic response modifier with immunomodulatory, antiangiogenic, and antineoplastic properties
    Used for adult patients with myelodysplastic syndrome, multiple myeloma, mantle cell lymphoma, follicular lymphoma, and marginal zone lymphoma
    Risk of birth defects or embryo-fetal death if used during pregnancy; routine testing required; prescribers, pharmacies

    Indicated for 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

    Multiple Myeloma

    Treatment

    • Indicated in combination with dexamethasone for treatment of multiple myeloma (MM)

    Maintenance

    • Indicated as maintenance therapy for MM following autologous hematopoietic stem cell transplantation (auto-HSCT)

    Indicated for MCL in patients whose disease has relapsed or progressed after 2 prior therapies, 1 of which included bortezomib

    Indicated in combination with a rituximab product, for treatment of patients with previously treated follicular lymphoma (FL) or marginal zone lymphoma (MZL)

    Pregnancy; sexually active women of childbearing potential not using 2 forms of contraception

    Demonstrated hypersensitivity (eg, angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis)

    • Thrombocytopenia (62%)
    • Neutropenia (59%)
    • Diarrhea (48%)
    • Pruritus (42%)
    • Nausea (35%)
    • Rash (35%)
    • Fatigue (31%)
    • Constipation (24%)
    • Arthralgia (22%)
    • Back pain (21%)
    • Peripheral edema (21%)
    • Pyrexia (21%)
    • Dizziness (20%)
    • Headache (20%)
    • Cough (19%)
    • Muscle cramp (18%)
    • Dyspnea (17%)
    • URTI (15%)
    • Anemia (12%)
    • Pneumonia (12%)
    • UTI (11%)

    Risk of hematologic toxicity; can cause significant neutropenia and thrombocytopenia 

    Use caution in renal impairment

    Increases risk of mortality in patients with CLL with monotherapy; therapy not indicated and not recommended in CLL outside of controlled clinical trials

    Fatal instances of tumor lysis syndrome reported

    Patients must not donate blood during treatment and for 4 weeks following discontinuation of drug because blood might be given to pregnant female patient whose fetus must not be exposed to drug

    Tumor flare reaction (TFR) has occurred during investigational use for CLL and lymphoma, and is characterized by tender lymph node swelling, low grade fever, pain and rash; tumor flare may mimic progression of disease; may continue treatment if grade 1 or 2 TFR (treat with corticosteroids, NSAIDs, and/or narcotic analgesics), hold treatment for grade 3 or 4 TFR until resolves to ≤Grade 1

    Hepatic failure, including fatal cases, has occurred when administered in combination with dexamethasone; the mechanism of drug-induced hepatotoxicity is unknown; pre-existing viral liver disease, elevated baseline liver enzymes, and concomitant medications may be risk factors; monitor liver enzymes periodically; stop therapy upon elevation of liver enzymes; after return to baseline values, treatment at a lower dose may be considered

    Patients treated with lenalidomide (with melphalan and stem cell transplantation) had higher incidence of second primary malignancies, particularly acute myelogenous leukemia (AML) and Hodgkin lymphoma, compared to patients in the control arms who received similar therapy but did not receive lenalidomide

    Monitor patients for development of second primary malignancies; take into account both potential benefit of therapy and risk of second primary malignancies when considering therapy

    Contraindicated during pregnancy 

    Unknown if distributed into human breast milk

    Adults

    25 mg/day PO.

    Geriatric

    25 mg/day PO.

    Adolescents

    Safety and efficacy have not been established.

    Children

    Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    Lenalidomide 

    capsule (Revlimid, generic)

    • 2.5mg
    • 5mg
    • 10mg
    • 15mg
    • 20mg
    • 25mg