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:
For:
Oral, 25 milligrams lenalidomide, once daily, 21 doses in total, over the duration of 28 days.
Recommended dose:
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 days 5 mg every other day on days 1 to 21, every 28 days |
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 |
Absolute neutrophil count (ANC) - neutropenia:
| When ANC | Recommended course |
|---|---|
| Falls to <1 × 109/L for at least 7 days or Falls to <1 × 109/L with associated fever (body temperature ≥38.5°C) or Falls to <0.5 × 109/L | Interrupt lenalidomide treatment and conduct the CBC at least every 7 days |
| Returns 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 |
All patients should receive TLS prophylaxis (allopurinol, rasburicase or equivalent as per institutional guidelines) and be well hydrated (orally) during the first week of the first cycle or for a longer period if clinically indicated. To monitor for TLS, patients should have a chemistry panel drawn weekly during the first cycle and as clinically indicated.
Lenalidomide may be continued (maintain dose) in patients with laboratory TLS or Grade 1 clinical TLS, or at the physician’s discretion, reduce dose by one level and continue lenalidomide. Vigorous intravenous hydration should be provided and appropriate medical management according to the local standard of care, until correction of electrolyte abnormalities. Rasburicase therapy may be needed to reduce hyperuricaemia. Hospitalisation of the patient will be at physician’s discretion.
In patients with Grade 2 to 4 clinical TLS, interrupt lenalidomide and obtain a chemistry panel weekly or as clinically indicated. Vigorous intravenous hydration should be provided and appropriate medical management according to the local standard of care, until correction of electrolyte abnormalities.
Rasburicase therapy and hospitalisation will be at physician’s discretion. When the TLS resolves to Grade 0, restart lenalidomide at next lower dose per physician’s discretion.
At the physician’s discretion, lenalidomide may be continued in patients with Grade 1 or 2 tumour flare reaction (TFR) without interruption or modification. At the physician’s discretion, therapy with non-steroidal anti-inflammatory drugs (NSAIDs), limited duration corticosteroids, and/or narcotic analgesics may be administered. In patients with Grade 3 or 4 TFR, withhold treatment with lenalidomide and initiate therapy with NSAIDs, corticosteroids and/or narcotic analgesics. When TFR resolves to ≤ Grade 1, restart lenalidomide treatment at the same dose level for the rest of the cycle. Patients may be treated for management of symptoms per the guidance for treatment of Grade 1 and 2 TFR.
Lenalidomide should be taken orally at about the same time on the scheduled days, either with or without food.
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