d starting dose of REVLIMID is 25 mg once daily orally with water on Days 1-21 of repeated 28-day cycles. Patients should not break, chew or open the capsules. The recommended dose of dexamethasone is 40 mg once daily on Days 1-4, 9-12, and 17-20 of each 28-day cycle for the first 4 cycles of therapy and then 40 mg once daily orally on Days 1-4 every 28 days. Treatment is continued or modified based upon clinical and laboratory findings.
Dose Adjustments for Hematologic Toxicities During Multiple Myeloma 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 lenalidomide.
Platelet counts
Thrombocytopenia in MM
Absolute Neutrophil counts (ANC)
Neutropenia in MM
Other Grade 3 / 4 Toxicities in MM
For other Grade 3/4 toxicities judged to be related to REVLIMID, hold treatment and restart at next lower dose level when toxicity has resolved to ≤ Grade 2.
Starting Dose Adjustment for Renal Impairment in MM
Since REVLIMD is primarily excreted unchanged by the kidney, adjustments to the starting dose of REVLIMID are recommended to provide appropriate drug exposure in patients with moderate or severe renal impairment and in patients on dialysis. Based on a pharmacokinetic study in patients with renal impairment due to nonmalignant conditions, REVLIMID starting dose adjustment is recommended for patients with CLcr < 60 mL/min. Non-dialysis patients with creatinine clearances less than 11 mL/min and dialysis patients with creatinine clearances less than 7 mL/min have not been studied. The recommendations for initial starting doses for patients with multiple myeloma (MM) are as follows:
After initiation of REVLIMID therapy, subsequent REVLIMID dose modification should be based on individual patient treatment tolerance, as described elsewhere in this section.
When Platelets Recommended Course
Fall to <30,000/mcL Interrupt REVLIMID treatment, follow CBC weekly
Return to ≥30,000/mcL Restart REVLIMID at 15 mg daily
For each subsequent drop <30,000/mcL Interrupt REVLIMID treatment
Return to ≥30,000/mcL Resume REVLIMID at 5 mg less than the previous dose. Do not dose below 5 mg daily
When Neutrophils Recommended Course
Fall to <1000/mcL Interrupt REVLIMID treatment, add G-CSF, follow CBC weekly
Return to ≥1,000/mcL and neutropenia is the only toxicity Resume REVLIMID at 25 mg daily
Return to ≥1,000/mcL and if other toxicity Resume REVLIMID at 15 mg daily
For each subsequent drop <1,000/mcL Interrupt REVLIMID treatment
Return to ≥1,000/mcL Resume REVLIMID at 5 mg less than the previous dose. Do not dose below 5 mg daily
Table 1: Starting Dose Adjustment for Renal Impairment in Multiple Myeloma (Days 1 – 21 of each 28 day cycle) Category Renal Function
(Cockcroft-Gault) Dose
Moderate Renal
Impairment CLcr 30-60 mL/min 10 mg
Every 24 hours
Severe Renal
Impairment CLcr < 30 mL/min
(not requiring dialysis) 15 mg
Every 48 hours
End Stage Renal
Disease CLcr < 30 mL/min
(requiring dialysis) 5 mg
Once daily. On dialysis days,
administer the dose following dialysis.
2.2Myelodysplastic Syndromes
The recommended starting dose of REVLIMID is 10 mg daily with water. Patients should not break, chew or open the capsules. Treatment is continued or mo
