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Lenalidomide Dosage

Medically reviewed by Drugs.com. Last updated on Aug 29, 2022.

Applies to the following strengths: 2.5 mg; 5 mg; 10 mg; 25 mg; 15 mg; 20 mg

Usual Adult Dose for:

Additional dosage information:

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 until disease progression or unacceptable toxicity

Maintenance therapy following 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 until disease progression or unacceptable toxicity

Comments:


Uses:

Usual Adult Dose for Myelodysplastic Disease

10 mg orally once a day; therapy is continued or modified based upon clinical and laboratory findings until disease progression or unacceptable toxicity

Use: Treatment of 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 Lymphoma

FOLLICULAR LYMPHOMA OR MARGINAL ZONE LYMPHOMA:
20 mg orally once a day on Days 1 through 21 of repeated 28-day cycles for up to 12 cycles in combination with a rituximab-product

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

Uses:

Use: In combination with a rituximab product for the treatment of previously treated follicular lymphoma (FL)

Renal Dose Adjustments

DOSE ADJUSTMENTS IN COMBINATION THERAPY IN MULTIPLE MYELOMA (MM) AND MANTLE CELL LYMPHOMA (MCL):


DOSE ADJUSTMENTS IN COMBINATION THERAPY IN FOLLICULAR LYMPHOMA (FL) AND MARGINAL ZONE LYMPHOMA (MZL):

DOSE ADJUSTMENTS IN maintenance therapy following auto-HSCT for multiple myeloma (MM) and MYELODYSPLASTIC SYNDROMES (MDS):

Liver Dose Adjustments

Mild hepatic impairment (total bilirubin greater than 1 to 1.5 times upper limit normal (ULN) or any aspartate transaminase greater than ULN): No adjustment recommended.
Moderate to severe hepatic impairment: Data not available

Dose Adjustments

DOSE ADJUSTMENTS FOR HEMATOLOGIC TOXICITIES FOR MULTIPLE MYELOMA (MM):
NEUTROPENIA IN MM:
When neutrophils:

THROMBOCYTOPENIA IN MM:
When platelets:

MAINTENANCE THERAPY FOLLOWING AUTO-HSCT:
DOSE ADJUSTMENTS FOR HEMATOLOGIC TOXICITIES DURING MM TREATMENT:
Dose modification guidelines are recommended to manage Grade 3 or 4 neutropenia or thrombocytopenia, or another Grade 3 or 4 toxicity judged to be related to this drug:
DOSE ADJUSTMENTS FOR HEMATOLOGIC TOXICITIES FOR MM:
NEUTROPENIA:
When neutrophils:
THROMBOCYTOPENIA:
When platelets:

DOSE ADJUSTMENTS FOR HEMATOLOGIC TOXICITIES DURING MYELODYSPLASTIC SYNDROMES (MDS) TREATMENT:
Patients who are dosed initially at 10 mg and who experience thrombocytopenia should have their dosage adjusted as follows:
IF THROMBOCYTOPENIA DEVELOPS WITHIN 4 WEEKS OF STARTING THERAPY AT 10 MG DAILY IN MDS:
IF BASELINE IS AT LEAST 100,000/MCL:
WHEN PLATELETS:
IF BASELINE IS BELOW 100,000/MCL:
WHEN PLATELETS:
IF THROMBOCYTOPENIA DEVELOPS AFTER 4 WEEKS OF STARTING THERAPY AT 10 MG DAILY IN MDS:
WHEN PLATELETS:
Patients who experience thrombocytopenia at 5 mg daily should have their DOSAGE ADJUSTED AS FOLLOWS:
IF THROMBOCYTOPENIA DEVELOPS DURING TREATMENT AT 5 MG DAILY IN MDS:
When platelets:
PATIENTS WHO ARE DOSED INITIALLY AT 10 MG AND EXPERIENCE NEUTROPENIA SHOULD HAVE THEIR DOSAGE ADJUSTED AS FOLLOWS:
ABSOLUTE NEUTROPHIL COUNTS (ANC):
IF NEUTROPENIA DEVELOPS WITHIN 4 WEEKS OF STARTING TREATMENT AT 10 MG DAILY IN MDS:
If baseline ANC is at least 1,000/mcL:
When neutrophils:
If baseline ANC is below 1,000/mcL:
When neutrophils:
IF NEUTROPENIA DEVELOPS AFTER 4 WEEKS OF STARTING TREATMENT AT 10 MG DAILY IN MDS:
When neutrophils:
PATIENTS WHO EXPERIENCE NEUTROPENIA AT 5 MG DAILY SHOULD HAVE THEIR DOSAGE ADJUSTED AS FOLLOWS:
IF NEUTROPENIA DEVELOPS DURING TREATMENT AT 5 MG DAILY IN MDS:
When neutrophils:

DOSE ADJUSTMENTS FOR HEMATOLOGIC TOXICITIES DURING MCL TREATMENT MANTLE CELL LYMPHOMA (MCL):
GRADE 3 OR 4 NEUTROPENIA OR THROMBOCYTOPENIA OR OTHER GRADE 3 OR 4 TOXICITIES:
THROMBOCYTOPENIA DURING TREATMENT IN MCL:
When platelets:
NEUTROPENIA DURING TREATMENT IN MCL:
When neutrophils:

DOSE ADJUSTMENTS FOR HEMATOLOGIC TOXICITIES DURING FOLLICULAR LYMPHOMA (FL) OR MARGINAL ZONE LYMPHOMA (MZL):
DOSE MODIFICATION GUIDELINES, SUMMARIZED BELOW, ARE RECOMMENDED FOR GRADE 3 OR 4 NEUTROPENIA OR THROMBOCYTOPENIA OR ANOTHER GRADE 3 OR 4 TOXICITY:
When platelets:
NEUTROPENIA DURING TREATMENT IN FL OR MZL:
WHEN NEUTROPHILS:

DOSE MODIFICATIONS FOR NONHEMATOLOGIC ADVERSE REACTIONS:

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: http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm

US BOXED WARNINGS:
EMBRYOFETAL TOXICITY:

Recommendations:
HEMATOLOGIC TOXICITY (Neutropenia and Thrombocytopenia):
Recommendations:
VENOUS and ARTERIAL THROMBOEMBOLISM:
Recommendations:

CONTRAINDICATIONS:

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

Consult WARNINGS section for additional precautions.

Dialysis

See RENAL IMPAIRMENT

Other Comments

Administration Advice:


Storage Requirements:

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:
HEPATIC: Liver enzymes
OCULAR: Visual ability
ONCOLOGIC: Second primary malignancies

Patient Advice:

Frequently asked questions

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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