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Revlimid Dosage

Medically reviewed by Drugs.com. Last updated on April 23, 2020.

Generic name: LENALIDOMIDE 2.5mg
Dosage form: capsule

Recommended Dosage for Multiple Myeloma

REVLIMID Combination Therapy

The recommended starting dose of REVLIMID is 25 mg orally once daily on Days 1-21 of repeated 28-day cycles in combination with dexamethasone. Refer to Section 14.1 for specific dexamethasone dosing. For patients greater than 75 years old, the starting dose of dexamethasone may be reduced [see Clinical Studies (14.1)]. Treatment should be continued until disease progression or unacceptable toxicity.

In patients who are not eligible for auto-HSCT, treatment should continue until disease progression or unacceptable toxicity. For patients who are auto-HSCT-eligible, hematopoietic stem cell mobilization should occur within 4 cycles of a REVLIMID-containing therapy [see Warnings and Precautions (5.12)].

Dose Adjustments for Hematologic Toxicities During MM Treatment

Dose modification guidelines, as summarized in Table 1 below, are recommended to manage Grade 3 or 4 neutropenia or thrombocytopenia or other Grade 3 or 4 toxicity judged to be related to REVLIMID.

Table 1: Dose Adjustments for Hematologic Toxicities for MM
Platelet counts
Thrombocytopenia in MM
When Platelets Recommended Course
Days 1-21 of repeated 28-day cycle
Fall below 30,000/mcL Interrupt REVLIMID treatment, follow CBC weekly
Return to at least 30,000/mcL Resume REVLIMID at next lower dose. Do not dose below 2.5 mg daily
For each subsequent drop below 30,000/mcL Interrupt REVLIMID treatment
Return to at least 30,000/mcL Resume REVLIMID at next lower dose. Do not dose below 2.5 mg daily
Absolute Neutrophil counts (ANC)
Neutropenia in MM
When Neutrophils Recommended Course
Days 1-21 of repeated 28-day cycle
Fall below 1000/mcL Interrupt REVLIMID treatment, follow CBC weekly
Return to at least 1,000/mcL and neutropenia is the only toxicity Resume REVLIMID at 25 mg daily or initial starting dose
Return to at least 1,000/mcL and if other toxicity Resume REVLIMID at next lower dose. Do not dose below 2.5 mg daily
For each subsequent drop below 1,000/mcL Interrupt REVLIMID treatment
Return to at least 1,000/mcL Resume REVLIMID at next lower dose. Do not dose below 2.5 mg daily

REVLIMID Maintenance Therapy Following Auto-HSCT

Following auto-HSCT, initiate REVLIMID maintenance therapy after adequate hematologic recovery (ANC at least 1000/mcL and/or platelet counts at least 75,000/mcL). The recommended starting dose of REVLIMID is 10 mg once daily continuously (Days 1-28 of repeated 28-day cycles) until disease progression or unacceptable toxicity. After 3 cycles of maintenance therapy, the dose can be increased to 15 mg once daily if tolerated.

Dose Adjustments for Hematologic Toxicities During MM Treatment

Dose modification guidelines, as summarized in Table 2 below, are recommended to manage Grade 3 or 4 neutropenia or thrombocytopenia or other Grade 3 or 4 toxicity judged to be related to REVLIMID.

Table 2: Dose Adjustments for Hematologic Toxicities for MM
Platelet counts
Thrombocytopenia in MM
When Platelets Recommended Course
Fall below 30,000/mcL Interrupt REVLIMID treatment, follow CBC weekly
Return to at least 30,000/mcL Resume REVLIMID at next lower dose, continuously for Days 1-28 of repeated 28-day cycle
If at the 5 mg daily dose,
For a subsequent drop below 30,000/mcL
Interrupt REVLIMID treatment. Do not dose below 5 mg daily for Day 1 to 21 of 28 day cycle
Return to at least 30,000/mcL Resume REVLIMID at 5 mg daily for Days 1 to 21of 28-day cycle. Do not dose below 5 mg daily for Day 1 to 21 of 28 day cycle
Absolute Neutrophil counts (ANC)
Neutropenia in MM
When Neutrophils Recommended Course
Fall below 500/mcL Interrupt REVLIMID treatment, follow CBC weekly
Return to at least 500/mcL Resume REVLIMID at next lower dose, continuously for Days 1-28 of repeated 28-day cycle
If at 5 mg daily dose,
For a subsequent drop below 500/mcL
Interrupt REVLIMID treatment. Do not dose below 5 mg daily for Days 1 to 21 of 28-day cycle
Return to at least 500/mcL Resume REVLIMID at 5 mg daily for Days 1 to 21 of 28-day cycle. Do not dose below 5 mg daily for Days 1 to 21 of 28-day cycle

Recommended Dosage for Myelodysplastic Syndromes

The recommended starting dose of REVLIMID is 10 mg daily. Treatment is continued or modified based upon clinical and laboratory findings. Continue treatment until disease progression or unacceptable toxicity.

Dose Adjustments for Hematologic Toxicities During MDS Treatment

Patients who are dosed initially at 10 mg and who experience thrombocytopenia should have their dosage adjusted as follows:

Platelet counts

If thrombocytopenia develops WITHIN 4 weeks of starting treatment at 10 mg daily in MDS

If baseline is at least 100,000/mcL
When Platelets Recommended Course
Fall below 50,000/mcL Interrupt REVLIMID treatment
Return to at least 50,000/mcL Resume REVLIMID at 5 mg daily
If baseline is below 100,000/mcL
When Platelets Recommended Course
Fall to 50% of the baseline value Interrupt REVLIMID treatment
If baseline is at least 60,000/mcL and returns to at least 50,000/mcL Resume REVLIMID at 5 mg daily
If baseline is below 60,000/mcL and returns to at least 30,000/mcL Resume REVLIMID at 5 mg daily

If thrombocytopenia develops AFTER 4 weeks of starting treatment at 10 mg daily in MDS

When Platelets Recommended Course
Fall below 30,000/mcL or below 50,000/mcL with platelet transfusions Interrupt REVLIMID treatment
Return to at least 30,000/mcL (without hemostatic failure) Resume REVLIMID at 5 mg daily

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 Recommended Course
Fall below 30,000/mcL or below 50,000/mcL with platelet transfusions Interrupt REVLIMID treatment
Return to at least 30,000/mcL (without hemostatic failure) Resume REVLIMID at 2.5 mg daily

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 Recommended Course
Fall below 750/mcL Interrupt REVLIMID treatment
Return to at least 1,000/mcL Resume REVLIMID at 5 mg daily
If baseline ANC is below 1,000/mcL
When Neutrophils Recommended Course
Fall below 500/mcL Interrupt REVLIMID treatment
Return to at least 500/mcL Resume REVLIMID at 5 mg daily

If neutropenia develops AFTER 4 weeks of starting treatment at 10 mg daily in MDS

When Neutrophils Recommended Course
Fall below 500/mcL for at least 7 days or below 500/mcL associated with fever (at least 38.5°C) Interrupt REVLIMID treatment
Return to at least 500/mcL Resume REVLIMID at 5 mg daily

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 Recommended Course
Fall below 500/mcL for at least 7 days or below 500/mcL associated with fever (at least 38.5°C) Interrupt REVLIMID treatment
Return to at least 500/mcL Resume REVLIMID at 2.5 mg daily

Recommended Dosage for Mantle Cell Lymphoma

The recommended starting dose of REVLIMID is 25 mg/day orally on Days 1-21 of repeated 28-day cycles for relapsed or refractory mantle cell lymphoma. Treatment should be continued until disease progression or unacceptable toxicity.

Treatment is continued, modified or discontinued based upon clinical and laboratory findings.

Dose Adjustments for Hematologic Toxicities During MCL Treatment

Dose modification guidelines as summarized below are recommended to manage Grade 3 or 4 neutropenia or thrombocytopenia or other Grade 3 or 4 toxicities considered to be related to REVLIMID.

Platelet counts

Thrombocytopenia during treatment in MCL

When Platelets Recommended Course
Fall below 50,000/mcL Interrupt REVLIMID treatment and follow CBC weekly
Return to at least 50,000/mcL Resume REVLIMID at 5 mg less than the previous dose. Do not dose below 5 mg daily

Absolute Neutrophil counts (ANC)

Neutropenia during treatment in MCL

When Neutrophils Recommended Course
Fall below 1000/mcL for at least 7 days
OR
Falls below 1,000/mcL with an associated temperature at least 38.5°C
OR
Falls below 500/mcL
Interrupt REVLIMID treatment and follow CBC weekly
Return to at least 1,000/mcL Resume REVLIMID at 5 mg less than the previous dose. Do not dose below 5 mg daily

Recommended Dosage for Follicular Lymphoma or Marginal Zone Lymphoma

The recommended starting dose of REVLIMID is 20 mg orally once daily on Days 1-21 of repeated 28-day cycles for up to 12 cycles of treatment in combination with a rituximab-product. Refer to Section 14.4 for specific rituximab dosing from the AUGMENT trial. For dose adjustments due to toxicity with rituximab, refer to the product prescribing information.

Dose Adjustments for Hematologic Toxicities during FL or MZL Treatment

Dose modification guidelines, as summarized below, are recommended to manage Grade 3 or 4 neutropenia or thrombocytopenia or other Grade 3 or 4 toxicity judged to be related to REVLIMID.

Platelet counts

Thrombocytopenia during treatment in FL or MZL

When Platelets Recommended Course
Fall below 50,000/mcL Interrupt REVLIMID treatment and follow CBC weekly.
Return to at least 50,000/mcL If patient starting dose was 20 mg daily, resume REVLIMID at 5 mg less than the previous dose. Do not dose below 5 mg daily.
If patient starting dose was 10 mg daily, resume at 5 mg less than previous dose. Do not dose below 2.5 mg daily.

Absolute Neutrophil counts (ANC)

Neutropenia during treatment in FL or MZL

When Neutrophils Recommended Course
Fall below 1,000/mcL for at least 7 days
OR
Falls below 1,000/mcL with an associated temperature at least 38.5°C
OR
Falls below 500 /mcL
Interrupt REVLIMID treatment and follow CBC weekly.
Return to at least 1,000/mcL If patient starting dose was 20 mg daily, resume REVLIMID at 5 mg less than the previous dose. Do not dose below 5 mg daily.
If patient starting dose was 10 mg daily, resume at 5 mg less than previous dose. Do not dose below 2.5 mg daily.

Dosage Modifications for Non-Hematologic Adverse Reactions

For non-hematologic Grade 3/4 toxicities judged to be related to REVLIMID, hold treatment and restart at the physician's discretion at next lower dose level when toxicity has resolved to Grade 2 or below.

Permanently discontinue REVLIMID for angioedema, anaphylaxis, Grade 4 rash, skin exfoliation, bullae, or any other severe dermatologic reactions [see Warnings and Precautions (5.9, 5.15)].

Recommended Dosage for Patients with Renal Impairment

The recommendations for dosing patients with renal impairment are shown in the following table [see Clinical Pharmacology (12.3)].

Table 3: Dose Adjustments for Patients with Renal Impairment
Renal Function
(Cockcroft-Gault)
Dose in REVLIMID Combination Therapy for MM and MCL Dose in REVLIMID Combination Therapy for FL and MZL Dose in REVLIMID Maintenance Therapy Following Auto-HSCT for MM and for MDS
CLcr 30 to 60 mL/min 10 mg once daily 10 mg once daily 5 mg once daily
CLcr below 30 mL/min (not requiring dialysis) 15 mg every other day 5 mg once daily 2.5 mg once daily
CLcr below 30 mL/min (requiring dialysis) 5 mg once daily. On dialysis days, administer the dose following dialysis. 5 mg once daily. On dialysis days, administer the dose following dialysis. 2.5 mg once daily. On dialysis days, administer the dose following dialysis.

REVLIMID Combination Therapy for MM: For CLcr of 30 to 60 mL/min, consider escalating the dose to 15 mg after 2 cycles if the patient tolerates the 10 mg dose of lenalidomide without dose-limiting toxicity.

REVLIMID Maintenance Therapy Following Auto-HSCT for MM and for MCL and MDS: Base subsequent REVLIMID dose increase or decrease on individual patient treatment tolerance [see Dosage and Administration (2.1- 2.3)].

REVLIMID Combination Therapy for FL or for MZL: For patients with CLcr of 30 to 60 mL/min, after 2 cycles, the REVLIMID dose may be increased to 15 mg orally if the patient has tolerated therapy.

Administration

Advise patients to take REVLIMID orally at about the same time each day, either with or without food. Advise patients to swallow REVLIMID capsules whole with water and not to open, break, or chew them.

Further information

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