Active Ingredient: Lenalidomide
Lenalidomide in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 10 milligrams lenalidomide, once daily, 21 doses in total, over the duration of 28 days.
Lenalidomide treatment must not be started if the ANC <1.0 × 109/L, and/or platelet counts <75 × 109/L or, dependent on bone marrow infiltration by plasma cells, platelet counts <30 × 109/L.
Recommended dose:
The recommended starting dose of lenalidomide is 25 mg orally once daily on days 1 to 21 of repeated 28-day cycles. The recommended dose of dexamethasone is 40 mg orally once daily on days 1 to 4, 9 to 12, and 17 to 20 of each 28-day cycle for the first 4 cycles of therapy and then 40 mg once daily on days 1 to 4 every 28 days.
Prescribing physicians should carefully evaluate which dose of dexamethasone to use, taking into account the condition and disease status of the patient.
Dose reduction steps:
| Starting dose | 25 mg |
| Dose level -1 | 15 mg |
| Dose level -2 | 10 mg |
| Dose level -3 | 5 mg |
Thrombocytopenia:
| When platelets | Recommended course |
|---|---|
| First fall to <30 × 109/L | Interrupt lenalidomide treatment |
| Return to ≥30 × 109/L | Resume lenalidomide at dose level -1 |
| For each subsequent drop below 30 × 109/L | Interrupt lenalidomide treatment |
| Return to ≥30 × 109/L | Resume lenalidomide at next lower dose level (dose level -2 or -3) once daily. Do not dose below 5 mg once daily. |
Absolute neutrophil count (ANC) - neutropenia:
| When ANC | Recommended coursea |
|---|---|
| First falls to <0.5 × 109/L | Interrupt lenalidomide treatment |
| Returns to ≥0.5 × 109/L when neutropenia is the only observed toxicity | Resume lenalidomide at starting dose once daily |
| Returns to ≥0.5 × 109/L when dose-dependent haematological toxicities other than neutropenia are observed | Resume lenalidomide at dose level -1 once daily |
| For each subsequent drop below <0.5 × 109/L | Interrupt lenalidomide treatment |
| Returns to ≥0.5 × 109/L | Resume lenalidomide at next lower dose level (dose level -1, -2 or -3) once daily. Do not dose below 5 mg once daily. |
a At the physician’s discretion, if neutropenia is the only toxicity at any dose level, add granulocyte colony stimulating factor (G-CSF) and maintain the dose level of lenalidomide.
Lenalidomide should be taken orally at about the same time on the scheduled days, either with or without food.
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