Classes
DEA Class; Rx
Common Brand Names; Revlimid
- Antineoplastics, Angiogenesis Inhibitor
Description
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
Indications
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)
Contraindications
Pregnancy; sexually active women of childbearing potential not using 2 forms of contraception
Demonstrated hypersensitivity (eg, angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis)
Adverse Effects
- 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%)
Warnings
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
Pregnancy and Lactation
Contraindicated during pregnancy
Unknown if distributed into human breast milk
Maximum Dosage
25 mg/day PO.
25 mg/day PO.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Lenalidomide
capsule (Revlimid, generic)
- 2.5mg
- 5mg
- 10mg
- 15mg
- 20mg
- 25mg