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

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

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

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

Starting Dose Adjustment for Renal Impairment in MDS: Since REVLIMID 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 myelodysplastic syndromes (MDS) 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.

If baseline ≥100,000/mcL
When Platelets  Recommended Course 
Fall to <50,000/mcL Interrupt REVLIMID treatment
Return to ≥50,000/mcL Resume REVLIMID at 5 mg daily
If baseline <100,000/mcL 
When Platelets  Recommended Course 
Fall to 50% of the baseline value Interrupt REVLIMID treatment
If baseline ≥60,000/mcL and
returns to ≥50,000/mcL Resume REVLIMID at 5 mg daily
If baseline <60,000/mcL and
returns to ≥30,000/mcL Resume REVLIMID at 5 mg daily
When Platelets Recommended Course
<30,000/mcL or <50,000/mcL
with platelet transfusions Interrupt REVLIMID treatment
Return to ≥30,000/mcL (without hemostatic failure) Resume REVLIMID at 5 mg daily
When Platelets Recommended Course
<30,000/mcL or <50,000/mcL
with platelet transfusions Interrupt REVLIMID treatment
Return to ≥30,000/mcL
(without hemostatic failure) Resume REVLIMID at 5 mg every other day
If baseline ANC ≥1,000/mcL
When Neutrophils  Recommended Course 
Fall to <750/mcL Interrupt REVLIMID treatment
Return to ≥1,000/mcL Resume REVLIMID at 5 mg daily
If baseline ANC <1,000/mcL 
When Neutrophils  Recommended Course 
Fall to <500/mcL Interrupt REVLIMID treatment
Return to ≥500/mcL Resume REVLIMID at 5 mg daily
When Neutrop