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For patients who have undergone Auto-HSCT: Lenalidomide not be started if the Absolute Neutrophil Counts (ANC) <1.0 x 109/L, and/or platelet counts <75 x 109/L.
Adult: Recommended dose: The recommended starting dose of lenalidomide is 25 mg orally once daily on days 1-21 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. Dosing is continued or modified based upon clinical and laboratory findings. For patient ≥75 years of age, the starting dose of dexamethasone is 20 mg/day on days 1, 8, 15 and 22 of each 28-day treatment cycles. The recommended dose of Lenalidomide for patients suffering from moderate renal impairment (30 ≤ CLcr <50ml/min) is 10 mg once daily.
Recommended dose adjustments during treatment and restart of treatment: Dose adjustments, as summarized as follows, are recommended to manage grade 3 or 4 thrombocytopenia, neutropenia, or other grade 3 or 4 toxicity judged to be related to lenalidomide.
Dose reduction steps: See Table 1.
Click on icon to see table/diagram/imageThrombocytopenia: See Table 2.
Click on icon to see table/diagram/imageNeutropenia: See Table 3.
Click on icon to see table/diagram/imageIn case of neutropenia, the use of growth factors in patient management should be considered. If the dose of lenalidomide was reduced for a hematologic DLT, the dose of lenalidomide may be re-introduced to the next higher dose level (up to the starting dose) at the discretion of the treating physician if continued lenalidomide/dexamethasone therapy resulted in improved bone marrow function (no DLT for at least 2 consecutive cycles and an ANC ≥1,500/µl with a platelet count ≥ 100,000/µl at the beginning of a new cycle at the current dose level).
The recommended starting dose of Lenalidomide for Auto-HSCT is 10 mg orally once daily continuously (on days 1 to 28 of repeated 28-day cycles) given until disease progression or intolerance. After 3 cycles of lenalidomide maintenance, the dose can be increased to 15 mg orally once daily if tolerated.
Dose reduction steps: See Table 4.
Click on icon to see table/diagram/imageThrombocytopenia: See Table 5.
Click on icon to see table/diagram/imageNeutropenia: See Table 6.
Click on icon to see table/diagram/imageLenalidomide must be discontinued for angioedema, grade 4 rash, exfoliative or bullous rash, or if Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) or Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) is suspected, and should not be resumed following discontinuation from these reactions.
Multiple myeloma with at least one prior therapy: Lenalidomide treatment must not be started if the ANC <1.0 x 109/L, and/or platelet counts <75 x 109/L or, dependent on bone marrow infiltration by plasma cells, platelet counts <30 x 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: See Table 7.
Click on icon to see table/diagram/imageThrombocytopenia: See Table 8.
Click on icon to see table/diagram/imageNeutropenia: See Table 9.
Click on icon to see table/diagram/imageSpecial populations: Patients with hepatic function impairment: Lenalidomide has not formally been studied in patients with impaired hepatic function and there are no specific dose recommendations.
Pediatric patient: Lenalidomide should not be used in children and adolescents from birth to less than 18 years because of safety concerns.
Elderly patient: In patients with newly diagnosed multiple myeloma aged 75 years and older who received lenalidomide, there was a higher incidence of serious adverse reactions and adverse reactions that led to treatment discontinuation. Patients with newly diagnosed multiple myeloma aged 75 years and older should be carefully assessed before treatment is considered.
Newly diagnosed multiple myeloma: For patients older than 75 years of age treated with lenalidomide in combination with dexamethasone, the starting dose of dexamethasone is 20 mg/day on days 1, 8, 15 and 22 of each 28-day treatment cycle.
Multiple myeloma with at least one prior therapy: The percentage of multiple myeloma patients aged 65 or over was not significantly different between the lenalidomide/dexamethasone and placebo/dexamethasone groups. No overall difference in safety or efficacy was observed between these patients and younger patients, but greater pre-disposition of older individuals cannot be ruled out.
Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection and it would be prudent to monitor renal function.
Patients with renal impairment: Lenalidomide is substantially excreted by the kidney; patients with greater degrees of renal impairment can have impaired treatment tolerance. Care should be taken in dose selection and monitoring of renal function is advised. No dose adjustments are required for patients with mild renal impairment and multiple myeloma, myelodysplastic syndromes or mantle cell lymphoma. The following dose adjustments are recommended at the start of therapy and throughout treatment for patients with moderate or severe impaired renal function or end stage renal disease. There are no phase III trial experiences with End Stage Renal Disease (ESRD) (CLcr <30 mL/min, requiring dialysis).
Multiple myeloma: See Table 10.
Click on icon to see table/diagram/imageAdministration: Oral use.
Lenalidomide capsules should be taken orally at about the same time on the scheduled days. The capsules should not be opened, broken or chewed. The capsules should be swallowed whole, preferably with water, either with or without food. If less than 12 hours has elapsed since missing a dose, the patient can take the dose. If more than 12 hours has elapsed since missing a dose at the normal time, the patient should not take the dose, but take the next dose at the normal time on the following day.
