Active Ingredient: Lenalidomide
Lenalidomide in combination with dexamethasone until disease progression in patients who are not eligible for transplant.
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.
Lenalidomide treatment must not be started if the ANC is <1.0 × 109/L, and/or platelet counts are <50 × 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, 8, 15 and 22 of repeated 28-day cycles. Patients may continue lenalidomide and dexamethasone therapy until disease progression or intolerance.
Dose reduction steps:
| Lenalidomidea | Dexamethasonea | |
|---|---|---|
| Starting dose | 25 mg | 40 mg |
| Dose level -1 | 20 mg | 20 mg |
| Dose level -2 | 15 mg | 12 mg |
| Dose level -3 | 10 mg | 8 mg |
| Dose level- 4 | 5 mg | 4 mg |
| Dose level -5 | 2.5 mg | Not applicable |
a Dose reduction for both products can be managed independently
Thrombocytopenia:
| When platelets | Recommended course |
|---|---|
| Fall to <25 × 109/L | Stop lenalidomide dosing for remainder of cyclea |
| Return to ≥50 × 109/L | Decrease by one dose level when dosing resumed at next cycle |
a If Dose limiting toxicity (DLT) occurs on >day15 of a cycle, lenalidomide dosing will be interrupted for at least the remainder of the current 28-day cycle.
Absolute neutrophil count (ANC) - neutropenia:
| When ANC | Recommended coursea |
|---|---|
| First falls to <0.5 × 109/L | Interrupt lenalidomide treatment |
| Returns to ≥1 × 109/L when neutropenia is the only observed toxicity | Resume lenalidomide at starting dose once daily |
| Returns to ≥0.5 × 109P/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 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.
For hematologic toxicity the dose of lenalidomide may be re-introduced to the next higher dose level (up to the starting dose) upon improvement in bone marrow function (no hematologic toxicity for at least 2 consecutive cycles: ANC ≥1,5 × 109/L with a platelet count ≥100 × 109/L at the beginning of a new cycle).
Lenalidomide should be taken orally at about the same time on the scheduled days, either with or without food.
Liability Disclaimer : RxReasoner has utilized reasonable care in providing content and services that are accurate, complete and up to date. However, RxReasoner does not accept any responsibility or liability about it. The content and services of RxReasoner are for informational purposes only and they are not intended to be a substitute for the knowledge, expertise, skill, and judgment of physicians, pharmacists, nurses, or other healthcare professionals involved in patient care. RxReasoner offers no medical advice. Users are responsible for the use of the provided content. A shown indication or treatment should not be construed to indicate that the medication is safe, appropriate, or effective in any given patient or under any particular circumstances. The absence of an indication or treatment should not roule out the existence of other appropriate medications. Always seek the advice of a physician or other qualified health provider with any questions you may have regarding a medical condition or medicament. RxReasoner is not liable for any damages allegedly sustained arising out of the use of its content and services.
