ession 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 (5.11)].
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 to <30,000/mcL Interrupt REVLIMID treatment, follow CBC weekly
Return to ≥30,000/mcL Resume REVLIMID at next lower dose. Do not dose below 2.5 mg daily
For each subsequent drop <30,000/mcL Interrupt REVLIMID treatment
Return to ≥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 to <1000/mcL Interrupt REVLIMID treatment, follow CBC
weekly
Return to ≥1,000/mcL and neutropenia is the only toxicity Resume REVLIMID at 25 mg daily or initial
starting dose
Return to ≥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 <1,000/mcL Interrupt REVLIMID treatment
Return to ≥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 ≥ 1000/mcL and/or platelet counts ≥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 to <30,000/mcL Interrupt REVLIMID treatment, follow CBC weekly
Return to ≥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 <30,000/mcL
Interrupt REVLIMID treatment. Do not dose below 5 mg daily for Day 1 to 21 of 28 day cycle
Return to ≥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 to <500/mcL Interrupt REVLIMID treatment, follow CBC weekly
Return to ≥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 <500/mcL
Interrupt REVLIMID treatment. Do not dose below 5 mg daily for Days 1 to 2
