Active Ingredient: Lenalidomide
Lenalidomide as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma.
For this indication, competent medicine agencies globally authorize below treatments:
Oral
25 mg
25 mg once every day
The recommended starting dose of lenalidomide is 25 mg orally once daily on days 1 to 21 of repeated 28-day cycles.
Dose reduction steps:
| Starting dose | 25 mg once daily on days 1 to 21, every 28 days |
| Dose Level -1 | 20 mg once daily on days 1 to 21, every 28 days |
| Dose Level -2 | 15 mg once daily on days 1 to 21, every 28 days |
| Dose Level -3 | 10 mg once daily on days 1 to 21, every 28 days |
| Dose Level -4 | 5 mg once daily on days 1 to 21, every 28 days |
| Dose Level -5 | 2.5 mg once daily on days 1 to 21, every 28 days1 |
| 5 mg every other day on days 1 to 21, every 28 days |
1 In countries where the 2.5 mg capsule is available.
Thrombocytopenia:
| When platelets | Recommended Course |
|---|---|
| Fall to <50 × 109/L | Interrupt lenalidomide treatment and conduct Complete Blood Count (CBC) at least every 7 days |
| Return to ≥ 60 × 109/L | Resume lenalidomide at next lower level (dose level -1) |
| For each subsequent drop below 50 × 109/L | Interrupt lenalidomide treatment and conduct the CBC at least every 7 days |
| Return to ≥60 × 109/L | Resume lenalidomide at next lower level (dose level -2, -3, -4 or -5). Do not dose below dose level -5 |
Neutropenia:
| When neutrophils | Recommended Course |
|---|---|
| Fall to <1 × 109/L for at least 7 days or | Interrupt lenalidomide treatment and conduct the CBC at least every 7 days |
| Falls to <1 × 109/L with associated fever (body temperature ≥38.5°C) or | |
| Falls to <0.5 × 109/L | |
| Return to ≥1 × 109/L | Resume lenalidomide at next lower dose level (dose level -1) |
| For each subsequent drop below 1 × 109/L for at least 7 days or drop to <1 × 109/L with associated fever (body temperature ≥38.5°C) or drop to <0.5 × 109/L | Interrupt lenalidomide treatment |
| Returns to ≥1 × 109/L | Resume Lenalidomide at next lower dose level (dose level -2, -3, -4, -5). Do not dose below dose level -5 |
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