Skip to Content

Lenalidomide Dosage

Applies to the following strength(s): 2.5 mg ; 5 mg ; 10 mg ; 15 mg ; 20 mg ; 25 mg

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Usual Adult Dose for Myelodysplastic Disease

10 mg orally once a day
Duration of Therapy: Treatment is continued or modified based upon clinical and laboratory findings.

Use: Treatment of patients with 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.

Usual Adult Dose for Multiple Myeloma

-In combination with dexamethasone: 25 mg orally once a day on Days 1 to 21 of repeated 28-day cycles
-Maintenance therapy following autologous hematopoietic stem cell transplantation (auto-HSCT): 10 mg once a day continuously (Days 1 to 28 of repeated 28-day cycles) for 3 cycles, then increase to 15 mg once a day if tolerated.
-Duration of Therapy (both indications): Until disease progression or unacceptable toxicity.

Comments:
-Following auto-HSCT, initiate maintenance therapy after adequate hematologic recovery (ANC 1000/mcL or more AND/OR platelet count 75,000/mcL or more).
-For patients who are eligible for auto-HSCT, hematopoietic stem cell mobilization should occur within 4 cycles of a treatment regimen containing this drug.
-Consult the manufacturer product information for dexamethasone dosing recommendations.

Uses:
-In combination with dexamethasone, treatment of patients with multiple myeloma (MM).
-Maintenance therapy in patients with MM following auto-HSCT.

Usual Adult Dose for Lymphoma

25 mg orally once a day on Days 1 to 21 of repeated 28-day cycles.
Duration of Therapy: Until disease progression or unacceptable toxicity; treatment is continued, modified, or discontinued based upon clinical and laboratory findings.

Use: Treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after 2 prior therapies, one of which included bortezomib.

Renal Dose Adjustments

MULTIPLE MYELOMA (MM) and MANTLE CELL LYMPHOMA (MCL):
-CrCl greater than 60 mL/min: No adjustment recommended.
-CrCl 30 to 60 mL/min: 10 mg once a day; consider escalating the dose to 15 mg after 2 cycles if the patient tolerates the 10 mg dose without dose-limiting toxicity.
-CrCl less than 30 mL/min (Non-Dialysis): 15 mg every other day.

MYELODYSPLASTIC SYNDROMES (MDS):
-CrCl greater than 60 mL/min: No adjustment recommended.
-CrCl 30 to 60 mL/min: 5 mg once a day.
-CrCl less than 30 mL/min (Non-Dialysis): 2.5 mg once a day.

MAINTENANCE THERAPY FOLLOWING AUTO-HSCT (MM, MDS, MCL): Base subsequent dose adjustment(s) on individual patient treatment tolerance.

Liver Dose Adjustments

-IMPAIRED HEPATIC FUNCTION: There are no dose adjustments provided in the manufacturer product information; however, it has been observed that mild hepatic impairment does not influence drug clearance. Data not available for moderate to severe hepatic impairment.
-IF ABNORMAL LIVER FUNCTION TEST RESULTS/ELEVATED LIVER ENZYMES ARE REPORTED: Interrupt treatment; consider resuming treatment at a lower dose once parameters have returned to baseline.

Dose Adjustments

GRADE 3/4 NEUTROPENIA AND/OR THROMBOCYTOPENIA:

MULTIPLE MYELOMA (MM):
Neutropenia:
When Neutrophils:
-Fall to Less than 1000/mcL: Interrupt treatment and follow CBC weekly.
-Return to 1000/mcL or more AND Neutropenia is Only Toxicity: Resume treatment at 25 mg/day or initial starting dose.
-Return to 1000/mcL or more AND If Other Toxicity: Resume treatment at next lower dose; do not dose below 2.5 mg/day.
-Each Subsequent Drop Below 1000/mcL: Interrupt treatment.
-Each Subsequent Return to 1000/mcL or More: Resume treatment at next lower dose; do not dose below 2.5 mg/day.

Thrombocytopenia:
When Platelets:
-Fall to Less than 30,000/mcL: Interrupt treatment and follow CBC weekly.
-Return to 30,000/mcL or More: Resume treatment at next lower dose; do not dose below 2.5 mg/day.
-Each Subsequent Drop Below 30,000/mcL: Interrupt treatment.
-Each Subsequent Return to 30,000/mcL or More: Resume treatment at next lower dose; do not dose below 2.5 mg/day.

MAINTENANCE THERAPY FOLLOWING AUTO-HSCT:
Neutropenia:
When Neutrophils:
-Fall to Less than 500/mcL: Interrupt treatment and follow CBC weekly.
-Return to 500/mcL or More: Resume treatment at next lower dose continuously for Days 1 to 28 of repeated 28-day cycle.

If at 5 mg/day Dose:
-Subsequent Drop Below 500/mcL: Interrupt treatment; do not dose below 5 mg/day for Days 1 to 21 of 28-day cycle.
-Subsequent Return to Greater than 500/mcL: Resume treatment at 5 mg/day for Days 1 to 21 of 28-day cycle; do not dose below 5 mg/day.

Thrombocytopenia:
When Platelets:
-Fall to Less than 30,000/mcL: Interrupt treatment and follow CBC weekly.
-Return to 30,000/mcL or More: Resume treatment at next lower dose continuously for Days 1 to 28 of repeated 28-day cycle.

If at 5 mg/day Dose:
-Subsequent Drop Below 30,000/mcL: Interrupt treatment; do not dose below 5 mg/day for Days 1 to 21 of 28-day cycle.
-Subsequent Return to 30,000/mcL or More: Resume treatment at 5 mg/day for Days 1 to 21 of 28-day cycle; do not dose below 5 mg/day.

MYELODYSPLASTIC SYNDROMES (MDS):
WITHIN THE FIRST 4 WEEKS OF TREATMENT AT 10 MG DAILY:
Neutropenia:
Baseline ANC 1000/mcL or More:
When Neutrophils:
-Fall to Less than 750/mcL: Interrupt treatment.
-Return to 1000/mcL or More: Resume treatment at 5 mg/day.

Baseline ANC Less than 1000/mcL:
When Neutrophils:
-Fall to Less than 500/mcL: Interrupt treatment.
-Return to 500/mcL or More: Resume treatment at 5 mg/day.

Thrombocytopenia:
Baseline Platelets 100,000/mcL or More:
When Platelets:
-Fall to Less than 50,000/mcL: Interrupt treatment.
-Return to 50,000/mcL or More: Resume treatment at 5 mg/day.

Baseline Platelets Less than 100,000/mcL:
When Platelets:
-Fall to 50% of the Baseline Value: Interrupt treatment.

Baseline Platelets 60,000/mcL or More:
When Platelets:
-Return to 50,000/mcL or More: Resume treatment at 5 mg/day.

Baseline Platelets Less than 60,000/mcL:
When Platelets:
-Return to 30,000/mcL or More: Resume treatment at 5 mg/day.

AFTER 4 WEEKS OF STARTING TREATMENT AT 10 MG DAILY:
Neutropenia:
When Neutrophils:
-Fall to Less than 500/mcL for 7 Days or more OR Less than 500/mcL Associated with Fever (38.5 degrees Celsius or higher): Interrupt treatment.
-Return to 500/mcL or More: Resume treatment at 5 mg/day.

Thrombocytopenia:
When Platelets:
-Fall to Less than 30,000/mcL OR Less than 50,000/mcL with Platelet Transfusions: Interrupt treatment.
-Return to 30,000/mcL or More (without hemostatic failure): Resume treatment at 5 mg/day.

DURING TREATMENT AT 5 MG DAILY:
Neutropenia:
When Neutrophils:
-Fall to Less than 500/mcL for 7 Days or more OR Less than 500/mcL Associated with Fever (38.5 degrees Celsius or higher): Interrupt treatment.
-Return to 500/mcL or More: Resume treatment at 2.5 mg/day.

Thrombocytopenia:
When Platelets:
-Fall to Less than 30,000/mcL OR Less than 50,000/mcL with Platelet Transfusions: Interrupt treatment.
-Return to 30,000/mcL or More (without hemostatic failure): Resume treatment at 2.5 mg/day.

MANTLE CELL LYMPHOMA (MCL):
Neutropenia:
When Neutrophils
-Fall to Less than 1000/mcL for at least 7 Days OR Fall to Less than 1000/mcL with Associated Temperature (38.5 degrees or more Celsius) OR Fall to Less than 500/mcL: Interrupt treatment and follow CBC weekly.
-Return to 1000/mcL or More: Resume treatment at 5 mg less than the previous dose; do not dose below 5 mg/day.

Thrombocytopenia:
When Platelets:
-Fall to Less than 50,000/mcL: Interrupt treatment and follow CBC weekly.
-Return to 50,000/mcL or More: Resume treatment at 5 mg less than the previous dose; do not dose below 5 mg/day.

ALLERGIC REACTION:
-Grade 2 to 3 Skin Rash Occurs: Consider treatment interruption or discontinuation.
-Angioedema, Grade 4 Rash, Exfoliative or Bullous Rash Occurs, or Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis is Suspected: Permanently discontinue use of this drug.

TUMOR FLARE REACTION (TFR):
-Grade 1 or 2 TFR: Consider continuing use of this drug without interruption or modification.
-Grade 3 or 4 TFR: Withhold treatment until TFR resolves to Grade 1 or less.
-Comments: After careful clinical assessment of the individual patient, consider managing TFR symptoms with corticosteroids, non-steroidal anti-inflammatory drugs, and/or narcotic analgesics.

OTHER GRADE 3/4 TOXICITY IN MM, MDS, and MCL: Hold treatment and consider restarting at next lower dose level when toxicity has resolved to Grade 2 or less.

Precautions

The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for lenalidomide. It includes elements to assure safe use and an implementation system. For additional information: https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm

US BOXED WARNINGS:
-EMBRYO-FETAL TOXICITY: This drug is a thalidomide analog that should not be used during pregnancy. Thalidomide is a known human teratogen that causes severe life-threatening human birth defects; lenalidomide caused limb abnormalities in a developmental monkey study. If this drug is used during pregnancy, it may cause birth defects or embryo-fetal death. In females of reproductive potential, 2 negative pregnancy tests are required prior to treatment initiation and these patients must use 2 forms of contraception or continuously abstain from heterosexual sex during treatment and for 4 weeks after treatment completion.
-HEMATOLOGIC TOXICITY: This drug can cause significant neutropenia and thrombocytopenia. Grade 3 or 4 hematologic toxicity was seen in 80% of study patients. Patients with 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, and use of blood product support and/or growth factors.
-VENOUS AND ARTERIAL THROMBOEMBOLISM: This drug has 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 receiving this drug and dexamethasone. Patients should be advised to seek immediate medical care if they develop symptoms such as shortness of breath, chest pain, or arm/leg swelling. Thromboprophylaxis is recommended; the choice of regimen should be based on an assessment of the patient's underlying risks.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Dialysis Patients with CrCl less than 30 mL/min: 5 mg (MM and MCL) OR 2.5 mg (MDS) once a day.

Comments: On dialysis days, administer the dose following dialysis.

Other Comments

Administration Advice:
-Administer this drug at about the same time on the scheduled days, preferably with water and either with or without food.
-Instruct patients to swallow capsules whole; capsules should not be opened, broken, or chewed.
-Consult the manufacturer product information for instructions on administering this drug to patients with swallowing difficulties.
-Advise patients that in the event of a missed dose, the dose can be taken if less than 12 hours have elapsed since missing the dose; if more than 12 hours have elapsed, that dose should be skipped and the next dose should be taken at the normal time on the following day.
-If the powder from drug capsules makes contact with skin or mucous membranes, direct patients to wash affected skin immediately and thoroughly with soap and water and to flush affected membranes with water.

Storage Requirements:
-Store below 25 degrees Celsius.
-Keep drug in the original package.

Monitoring:
CARDIOVASCULAR: Signs/symptoms of thromboembolism
EMBRYOFETAL TOXICITY: Pregnancy (in females of reproductive potential)
ENDOCRINE: ENDOCRINE: Thyroid function
HEMATOLOGICAL: Signs/symptoms of neutropenia and thrombocytopenia:
-MM: CBC (weekly for the first 2 cycles, on Days 1 and 15 of cycle 3, and every 28 days thereafter)
-MDS: CBC (weekly for the first 8 weeks and at least monthly thereafter)
-MCL: CBC (weekly for the first 28-day cycle, every 2 weeks during Cycles 2 to 4, and monthly thereafter)
HEPATIC: Liver enzymes
OCULAR: Visual ability
ONCOLOGIC: Second primary malignancies

Patient Advice:
-Avoid potentially dangerous activities such as driving and operating machinery until you know how this drug affects you.
-Consult your healthcare provider on recommended methods of birth control to use while taking this drug.
-When removing a drug capsule from a blister pack, press only on one end of the capsule to reduce the risk of breaking the capsule.

Hide