Table 3 Recommended dose modifications/delays for lenalidomide
Condition | Recommended Course of Action |
|---|---|
Thrombocytopenia | |
Platelets falls to < 50 × 109/L | Interrupt lenalidomide treatment and conduct blood count at least every 7 days |
Platelets return to ≥ 50 × 109/L | Resume at next lower dose level (dose level − 1*) |
For each subsequent drop below 50 × 109/L | Interrupt lenalidomide treatment and conduct blood count at least every 7 days |
For each subsequent return to ≥ 50 × 109/L | Resume lenalidomide at next lower dose level (dose level − 2, -3*). Do not dose below dose level − 3. |
Neutropenia | |
ANC falls < 1.0 × 109/L for at least 7 days or falls to < 1.0 × 109/L with associated fever (body temperature ≥ 38.5 °C) or falls to < 0.5 × 109/L | Interrupt lenalidomide treatment and conduct blood count at least every 7 days |
ANC returns to ≥ 1.0 × 109/L | Resume lenalidomide at next lower dose level (dose level − 1*) |
For each subsequent drop below 1.0 × 109/L for at least 7 days or drop to < 1.0 × 109/L with associated fever (body temperature ≥ 38.5 °C) or drop to < 0.5 × 109/L | Interrupt lenalidomide treatment and conduct blood count at least every 7 days |
For each subsequent return to ≥ 1.0 × 109/L | Resume lenalidomide at next lower dose level (dose level − 2, -3*). Do not dose below dose level − 3 |
Renal Impairment | |
Moderate renal impairment (30 ≤ CrCl < 60 mL/min) | 10 mg once daily^ |
Severe renal impairment (CrCl < 30 mL/min, not requiring dialysis) | At the discretion of the investigator |
End stage renal disease (CrCl < 30 mL/min, requiring dialysis) | At the discretion of the investigator |