Pronunciation ⬇
le-na-LID-o-mide 
Classifications ⬆ ⬇
Therapeutic Classification: antineoplastics
Pharmacologic Classification: immunomodulatory agents
Indications ⬆ ⬇
REMS
- Transfusion-dependent anemia due to specific myelodysplastic syndromes associated with deletion 5q cytogenetic abnormality.
- Multiple myeloma (in combination with dexamethasone).
- Maintenance therapy in patients with multiple myeloma after autologous hematopoietic stem cell transplantation.
- Mantle cell lymphoma patients whose disease has relapsed or progressed after 2 prior therapies including bortezomib.
- Previously treated follicular lymphoma (in combination with rituximab).
- Previously treated marginal zone lymphoma (in combination with rituximab).
Action ⬆ ⬇
- Lenalidomide is a structural analog of thalidomide.
- Inhibits secretion of pro-inflammatory cytokines and increases secretion of anti-inflammatory cytokines.
Therapeutic Effects: - Decreased anemia in certain myelodysplastic syndromes with a decreased requirement for transfusions.
- Slowed progression of multiple myeloma and mantle cell lymphoma.
- Improved progression-free survival in follicular lymphoma and marginal zone lymphoma.
Pharmacokinetics ⬆ ⬇
Absorption: Well absorbed following oral administration. Levels are higher in patients with multiple myeloma.
Distribution: Crosses the placenta.
Metabolism/Excretion: 66% excreted unchanged in urine, some renal excretion involves active secretion.
Half-life: 3 hr.
Time/Action Profile ⬆ ⬇
(↓ need for transfusions)
Contraind./Precautions ⬆ ⬇
Contraindicated in:
- Hypersensitivity
- Chronic lymphocytic leukemia (↑ risk of mortality)
- Concurrent use of pembrolizumab in patients with multiple myeloma (↑ risk of mortality)
- OB: Pregnancy
- Lactation: Lactation.
Use Cautiously in:
- Renal impairment (may ↑ risk of adverse reactions; dose ↓ recommended if CCr <60 mL/min)
- Patients with mantle cell lymphoma with high tumor burden, high mantle cell lymphoma International Prognostic Index at diagnosis, and high white blood cell count at baseline (↑ risk of early mortality)
- Rep: Women of reproductive potential and men with female partners of reproductive potential
- Pedi: Safety and effectiveness not established in children
- Geri: Consider age-related ↓ in renal function in older adults.
Adv. Reactions/Side Effects ⬆ ⬇
CV: edema, chest pain, DEEP VEIN THROMBOSIS, MI, palpitations.
Derm: pruritus, rash, DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (DRESS), dry skin, STEVENS-JOHNSON SYNDROME (SJS), sweating, TOXIC EPIDERMAL NECROLYSIS (TEN).
Endo: hyperthyroidism, hypothyroidism.
F and E: hypokalemia, hypomagnesemia.
GI: abdominal pain, constipation, diarrhea, nausea, vomiting, abnormal taste, anorexia, dry mouth, HEPATOTOXICITY.
Hemat: neutropenia, thrombocytopenia.
MS: arthralgia, myalgia.
Neuro: dizziness, fatigue, headache, depression, insomnia, STROKE.
Resp: cough, pharyngitis, PULMONARY EMBOLISM.
Misc: fever, tumor flare reaction, chills, HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS AND ANGIOEDEMA), MALIGNANCY, tumor lysis syndrome.
Interactions ⬆ ⬇
Drug-Drug:
- Risk of neutropenia and thrombocytopenia may ↑ with antineoplastics, immunosuppressants, and radiation therapy.
- May ↑ digoxin levels.
- Erythropoeitin, darbepoeitin, and estrogens may ↑ risk of thromboembolic events
Route/Dosage ⬆ ⬇
Myelodysplastic Syndromes
- PO (Adults): 10 mg once daily.
Renal Impairment
- PO (Adults): CCr 30–60 mL/min: 5 mg once daily; CCr <30 mL/min (not on dialysis): 2.5 mg once daily; CCr <30 mL/min (requiring dialysis): 2.5 mg once daily (give after dialysis on dialysis days).
Multiple Myeloma
- PO (Adults): 25 mg once daily on days 1–21 of repeated 28-day cycles (with dexamethasone); if patients not eligible for auto-HSCT, continue treatment until disease progression or unacceptable toxicity; for patients eligible for auto-HSCT, hematopoietic stem cell mobilization should take place within 4 cycles.
Renal Impairment
- PO (Adults): CCr 30–60 mL/min: 10 mg once daily; if patient tolerates initial dose, may ↑ to 15 mg once daily after 2 cycles; CCr <30 mL/min (not on dialysis): 15 mg every 48 hr; CCr <30 mL/min (requiring dialysis): 5 mg once daily (give after dialysis on dialysis days).
Maintenance Therapy for Multiple Myeloma Following Autologous Hematopoietic Stem Cell Transplantation
- PO (Adults): After adequate hematologic recovery (ANC ≥ 1000/mcL and/or platelet counts ≥75,000/mcL), initiate therapy with 10 mg once daily continuously on Days 1–28 of repeated 28–day cycles); after 3 cycles, dose may be ↑ to 15 mg once daily, if tolerated; continue treatment until disease progression or unacceptable toxicity.
Renal Impairment
- PO (Adults): CCr 30–60 mL/min: 5 mg once daily; CCr <30 mL/min (not on dialysis): 2.5 mg once daily; CCr <30 mL/min (requiring dialysis): 2.5 mg once daily (give after dialysis on dialysis days).
Mantle Cell Lymphoma
- PO (Adults): 25 mg once daily on days 1–21 of repeated 28–day cycles; continue treatment until disease relapse or unacceptable toxicity develops.
Renal Impairment
- PO (Adults): CCr 30–60 mL/min: 10 mg once daily; CCr <30 mL/min (not on dialysis): 15 mg every 48 hr; CCr <30 mL/min (requiring dialysis): 5 mg once daily (give after dialysis on dialysis days).
Follicular Lymphoma or Marginal Zone Lymphoma
- PO (Adults): 20 mg once daily on days 1–21 of repeated 28–day cycles for up to 12 cycles (with rituximab).
Renal Impairment
- PO (Adults): CCr 30–60 mL/min: 10 mg once daily; if patient tolerates initial dose, may ↑ to 15 mg once daily after 2 cycles; CCr <30 mL/min (not on dialysis): 5 mg once daily; CCr <30 mL/min (requiring dialysis): 5 mg once daily (give after dialysis on dialysis days).
Availability ⬆ ⬇
(Generic available)
- Capsules: 2.5 mg; 5 mg; 10 mg; 15 mg; 20 mg; 25 mg;
Assessment ⬆ ⬇
- Assess for signs of deep venous thrombosis and pulmonary edema (dyspnea, chest pain, arm or leg swelling) periodically during therapy; risk is greater when lenalidomide is administered with dexamethasone.
- Assess for skin rash. Discontinue lenalidomide if rash occurs; may cause SJS, DRESS, or TEN. Consider interruption or discontinuation for Grade 2-3 skin rash. Permanently discontinue lenalidomide for Grade 4 rash, exfoliative or bullous rash, or for other severe cutaneous reactions such as SJS, TEN or DRESS.
- Monitor for signs and symptoms of tumor flare reaction (tender lymph node swelling, low-grade fever, pain rash) in patients with MCL; may mimic disease progression. Grade 1 and 2 tumor flare reaction (TFR): Lenalidomide may be continued in patients without interruption or modification, at health care professional's discretion. May also be treated with corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs) and/or opioid analgesics. Grade 3 or 4 TFR: withhold treatment with lenalidomide until TFR resolves to ≤ Grade 1. May be treated for management of symptoms per the guidance for treatment of Grade 1 and 2 TFR.
Lab Test Considerations: - Verify negative pregnancy status before starting therapy. Pregnancy tests with a sensitivity of at least 50 mIU/mL must be done within 10–14 days and within 24 hrs of starting therapy. Once treatment has started, verify negative pregnancy tests weekly during first 4 wk of use, then every 4 wk in females with a regular menstrual cycle and every 2 wk in females with an irregular cycle.
- Patients taking lenalidomide for multiple myeloma with dexamethasone or as maintenance therapy: Monitor CBC every 7 days for first 2 cycles, on days 1 and 15 of Cycle 3, and every 28 days thereafter. Patients taking lenalidomide for myelodysplastic syndrome: Monitor CBC with differential, platelet count, hemoglobin, and hematocrit weekly for first 8 wk of therapy and at least monthly thereafter. Patients taking lenalidomide for mantle cell lymphoma: Monitor CBC weekly for first 28 days, every 2 wk during Cycles 2–4, and monthly thereafter. May require dose interruption and/or reduction and use of blood support and/or growth factors.
- May cause neutropenia with an onset of 42 days (range 4–411 days) and recovery time of 17 days (range 2–170 days). For multiple myeloma: starting dose is 25 mg/day—If neutropenia develops and neutrophils fall to <1000/mcL interrupt therapy, follow CBC weekly. When neutrophils return to ≥1000/mcL and neutropenia is the only toxicity, resume lenalidomide at 25 mg daily. If neutrophils return to ≥1000/mcL and if other toxicity, resume lenalidomide at next lower dose. For each subsequent drop <1000/mcL interrupt therapy. If neutrophils return to ≥1000/mcL, resume at next lower dose. Do not administer doses below 2.5 mg. For myelodysplastic syndromes: starting dose is 10 mg/day—if neutropenia develops within 4 wk of starting at a 10 mg/day dose in a patient with a baseline neutrophil count (ANC) ≥1000/mcL and ANC falls to <750/mcL interrupt lenalidomide therapy and resume at 5 mg/day dose when ANC returns to ≥1000/mcL. If baseline ANC is <1000/mcL and ANC falls to <500/mcL, interrupt therapy and resume at 5 mg/day dose when ANC returns to ≥500/mcL. If neutropenia develops after 4 wk of therapy at 10 mg/day dose, and ANC <500/mcL for ≥7 days or <500/mcL associated with fever ≥38.5°C, interrupt therapy and resume at 5 mg/day when ANC returns to ≥500/mcL. If neutropenia develops at 5 mg/day dose and ANC <500/mcL for ≥7 days or <500/mcL associated with fever ≥38.5°C, interrupt therapy and resume at 2.5 mg daily when ANC returns to ≥500/mcL. For mantle cell lymphoma: starting dose is 25 mg/day on days 1–21 of repeated 28-day cycles—If neutrophils fall to <1000/mcL for at least 7 days or fall to <1000/mcL with fever ≥38.5°C or fall to <500/mcL, interrupt therapy and follow CBC weekly. If neutrophils return to ≥1000/mcL resume at 5 mg less than previous dose. Do not administer doses below 5 mg. For marginal zone lymphoma or follicular lymphoma: If neutrophils <1000/mcL for at least 7 days OR <1000/mcL with associated temperature at least 38.5° C OR <500/mcL hold lenalidomide and follow with weekly CBC. If neutrophils return to ≥1000/mcL and patient starting dose was 20 mg daily, resume at 5 mg less than previous dose. Do not administer doses below 5 mg. If neutrophils return to ≥1000/mcL patient starting dose was 10 mg daily, resume at 5 mg less than previous dose. Do not administer doses below 2.5 mg.
- May cause thrombocytopenia with an onset of 28 days (range 8–290 days) and a recovery in 22 days (range 5–224 days). For multiple myeloma: starting dose is 25 mg/day—If platelets fall to <30,000/mcL interrupt therapy and follow CBC weekly. When platelets return to ≥30,000/mcL restart lenalidomide at next lower dose. For each subsequent drop <30,000/mcL interrupt therapy. When platelets return to ≥30,000/mcL resume at next lower dose. Do not administer doses below 2.5 mg. For myelodysplastic syndrome: starting dose is 10 mg/day—If thrombocytopenia develops within 4 wk of starting a 10 mg dose in a patient with a baseline of ≥100,000/mcL, and platelets fall to <50,000/mcL interrupt lenalidomide therapy and resume at 5 mg/day dose when platelets return to >50,000/mcL. If baseline was <100,000/mcL and platelets fall to 50% of baseline value interrupt therapy. If baseline ≥60,000/mcL and returns to ≥50,000/mcL or if baseline is <60,000/mcL and returns to ≥30,000/mcL resume therapy at 5 mg/day. If thrombocytopenia develops after 4 wk of treatment at 10 mg/day and platelets are <30,000/mcL or <50,000/mcL with platelet transfusions, interrupt therapy. When platelets return to ≥30,000/mcL without hemostatic failure resume therapy at 2.5 mg/day. For mantle cell lymphoma: starting dose is 25 mg/day on days 1–21 of repeated 28–day cycles—If platelets fall to <50,000/mcL interrupt therapy and follow CBC weekly. If platelets return to ≥50,000/mcL resume at 5 mg less than previous dose. Do not administer doses below 5 mg. For follicular lymphoma or marginal cell lymphoma: if platelets <50,000/mcL, hold lenalidomide and follow with weekly CBC. When platelets return to ≥50,000/mcL, if starting dose was 20 mg daily, resume lenalidomide at 5 mg less than the previous dose. Do not dose below 5 mg daily. If starting dose was 10 mg daily, resume at 5 mg less than previous dose. Do not dose below 2.5 mg daily.
- Monitor liver enzymes periodically during therapy. Stop therapy if enzymes are elevated; may resume when return to normal or decrease dose.
- May cause anemia and leukopenia.
- May cause hypokalemia, hypomagnesemia, and ↑ ALT levels.
- Monitor thyroid function before starting and periodically during therapy.
Implementation ⬆ ⬇
- REMS: Patients must sign a Patient-Physician agreement form and must meet the following conditions before receiving therapy: they must understand the risks and be able to carry out instructions, must be capable of complying with patient registration and patient survey in the Lenalidomide REMS program, must comply with contraceptive measures, have received both oral and written warnings of the risks of contraception failure and the need for two reliable forms of contraception (females) or the risks of exposing a fetus to the drug and the need to use a latex condom during sexual conduct with a female with childbearing potential (male), acknowledge understanding of these warnings in writing, and if the patient is between 12 and 18 yr of age, their parent or legal guardian is to read the educational materials and agree to try to ensure compliance with conditions.
- REMS: Lenalidomide can only be prescribed by health care providers registered in the Lenalidomide REMS program and only be dispensed by a pharmacy that is registered in the Lenalidomide REMS program.
- Patients with multiple myeloma who are eligible for autologous stem cell transplantation should have stem cell mobilization performed within 4 cycles of therapy.
- PO: Administer once daily without regard to food, at the same time each day, with water. DNC: Swallow capsules whole; do not open, break, or chew.
Patient/Family Teaching ⬆ ⬇
- REMS: Lenalidomide is only available through a restricted program, the Lenalidomide REMS program. Instruct patient to take lenalidomide as directed and to comply with all aspects of the Lenalidomide REMS program. Take missed doses as soon as remembered within 12 hr of dose missed. If more than 12 hrs, skip dose and return to next scheduled dose; do not administer 2 doses within 12 hrs. Inform patient that they are required to participate in a telephone survey and patient registry while taking lenalidomide. Details are available at . Advise patient to read Medication Guide before starting and with each Rx refill in case of changes.
- Caution patient not to share lenalidomide with anyone, even someone who has similar symptoms.
- Advise patient to notify health care professional if rash, shortness of breath, chest pain, or arm or leg swelling, signs of infection (fever, dyspnea), rash, signs and symptoms of liver failure (yellowing of skin or white part of eyes; dark or brown (tea-colored) urine; pain on upper right side of your abdomen; feeling tired; unusual bleeding or bruising), hypersensitivity (swelling of lips, mouth, tongue, or throat; trouble breathing or swallowing; hives; very fast heartbeat; feeling dizzy or faint) occur.
- May cause dizziness. Caution patient to avoid driving and other activities requiring alertness until response to medication is known.
- Inform patient that lenalidomide may cause an increased risk of death in patients with mantle cell lymphoma and may increase risk of new cancers.
- Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
- Advise patient that they cannot donate blood during and for 1 mo following therapy and male patients cannot donate sperm while taking lenalidomide.
- Inform patient of risk of new cancers during therapy.
- Rep: May cause fetal harm. Inform females of reproductive potential that they must use one highly effective method (IUD, hormonal contraceptive, tubal ligation, partner's vasectomy) and one additional method (latex or synthetic condom, diaphragm, cervical cap) AT THE SAME TIME for ≥4 wk before, during therapy and interruptions of therapy, and for 4 wk following discontinuation of therapy, even with a history of infertility unless due to a hysterectomy or patient has been postmenopausal naturally for 24 consecutive mo. Advise female patients to avoid breast feeding during therapy. Males with female partners of reproductive potential receiving lenalidomide must always use a latex or synthetic condom during and for up to 4 wk following discontinuation, even if they have undergone a successful vasectomy. Male patients taking lenalidomide must not donate sperm during and for 4 wks after last dose. Lenalidomide must be discontinued if pregnancy is suspected or confirmed. Suspected fetal exposure must be reported to FDA via MedWatch at 1-800-FDA-1088 and to Celgene Corporation at 1-888-423-5436. Inform females there is a Pregnancy Exposure Registry that monitors pregnancy outcomes in females exposed to lenalidomide during pregnancy and that they can contact the Pregnancy Exposure Registry by calling 1-888-423-5436 or at .
Evaluation/Desired Outcomes ⬆ ⬇
- Decreased anemia in myelodysplastic syndromes with a decreased requirement for transfusions.
- Slowing of multiple myeloma progression.
- Slowing progression of mantle cell lymphoma.
- Improved progression-free survival in follicular lymphoma and marginal zone lymphoma.
US Brand Names ⬆ ⬇
Code ⬆
NDC Code*
- 59572- Celgene Corporation
- 59572- Celgene Corporation
- 59572- Celgene Corporation
- 59572- Celgene Corporation
- 59572- Celgene Corporation
- 59572- Celgene Corporation
- 59572- Celgene Corporation
- 59572- Celgene Corporation
- 59572- Celgene Corporation
- 59572- Celgene Corporation
- 59572- Celgene Corporation
- 59572- Celgene Corporation