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

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