Active Ingredient: Lenalidomide
Lenalidomide in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 – 3a).
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 20 milligrams lenalidomide, once daily, 21 doses in total, over the duration of 28 days. This step is repeated 12 times.
Lenalidomide treatment must not be started if the ANC is <1 × 109/L, and/or platelet count <50 × 109/L, unless secondary to lymphoma infiltration of bone marrow.
Recommended dose:
The recommended starting dose of lenalidomide is 20 mg, orally once daily on days 1 to 21 of repeated 28-day cycles for up to 12 cycles of treatment. The recommended starting dose of rituximab is 375 mg/m² intravenously (IV) every week in Cycle 1 (days 1, 8, 15, and 22) and day 1 of every 28-day cycle for cycles 2 through 5.
Dose reduction steps:
| Starting dose | 20 mg once daily on days 1-21, every 28 days |
| Dose Level -1 | 15 mg once daily on days 1-21, every 28 days |
| Dose Level -2 | 10 mg once daily on days 1-21, every 28 days |
| Dose Level -3 | 5 mg once daily on days 1-21, every 28 days |
For dose adjustments due to toxicity with rituximab, refer to the corresponding summary of product characteristics.
Thrombocytopenia:
| When platelets | Recommended course |
|---|---|
| Falls to <50 × 109/L | Interrupt lenalidomide treatment and conduct CBC at least every 7 days |
| Returns 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 CBC at least every 7 days |
| Returns to ≥50 × 109/L | Resume lenalidomide at next lower dose level (dose level -2, -3). Do not dose below dose level -3. |
Absolute neutrophil count (ANC) - neutropenia:
| When ANC | Recommended coursea |
|---|---|
| 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 CBC at least every 7 days |
| 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 CBC at least every 7 days |
| Returns to ≥1.0 × 109/L | Resume lenalidomide at next lower dose level (dose level -2, -3). Do not dose below dose level -3 |
a At the physician’s discretion, if neutropenia is the only toxicity at any dose level, add G-CSF
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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