Each capsule contains 7.5 mg of lenalidomide.
Excipient(s) with known effect:
Each capsule contains 144.5 mg of lactose, anhydrous.
For the full list of excipients, see section 6.1.
Revlimid treatment should be supervised by a physician experienced in the use of anti-cancer therapies.
Posology
Newly diagnosed multiple myeloma
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 (see section 4.4). For patients ≥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 cycle. The recommended dose of lenalidomide for patients suffering from moderate renal impairment is 10 mg once daily.
Recommended dose adjustments during treatment and restart of treatment:
Dose adjustments, as summarised below, 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
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Lenalidomide
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Dexamethasone
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Starting dose
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25 mg
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40 mg
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Dose level -1
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20 mg
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20 mg
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Dose level -2
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15 mg
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12 mg
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Dose level -3
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10 mg
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8 mg
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Dose level- 4
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5 mg
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4 mg
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Dose level -5
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2.5 mg
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NA
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• Thrombocytopenia
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When platelets
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Recommended course
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Fall to < 25 x 109/L
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Stop lenalidomide dosing for remainder of cycleª
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Return to ≥ 50 x 109/L
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Decrease by one dose level when dosing resumed at next cycle
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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.
• Neutropenia
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When neutrophils
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Recommended course
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First fall to < 0.5 x 109/L
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Interrupt lenalidomide treatment
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Return to ≥ 1 x 109/L when neutropenia is the only observed toxicity
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Resume lenalidomide at Starting dose once daily
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Return to ≥ 0.5 x 109/L when dose-dependent haematological toxicities other than neutropenia are observed
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Resume lenalidomide at Dose level -1 once daily
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For each subsequent drop below < 0.5 x 109/L
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Interrupt lenalidomide treatment
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Return to ≥ 0.5 x 109/L
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Resume lenalidomide at next lower dose level once daily.
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In 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).
Lenalidomide in combination with melphalan and prednisone followed by maintenance monotherapy in patients who are not eligible for transplant
Lenalidomide treatment must not be started if the Absolute Neutrophil Counts (ANC) is < 1.5 x 109/L, and/or platelet counts are < 75 x 109/L.
Recommended dose
The recommended starting dose is lenalidomide 10 mg/day orally on days 1-21 of repeated 28-day cycles for up to 9 cycles, melphalan 0.18 mg/kg orally on days 1-4 of repeated 28 day cycles, prednisone 2 mg/kg orally on days 1-4 of repeated 28-day cycles. Patients who complete 9 cycles or who are unable to complete the combination therapy due to intolerance are treated with lenalidomide alone,10 mg/day orally on days 1-21 of repeated 28-day cycles given until disease progression. Dosing is continued or modified based upon clinical and laboratory findings (see section 4.4).
Recommended dose adjustments during treatment and restart of treatment:
Dose adjustments, as summarised below, 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
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|
Lenalidomide
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Melphalan
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Prednisone
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Starting dose
|
10 mgª
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0.18 mg/kg
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2 mg/kg
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Dose level -1
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7.5 mg
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0.14 mg/kg
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1 mg/kg
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Dose level -2
|
5 mg
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0.10 mg/kg
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0.5 mg/kg
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Dose level -3
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2.5 mg
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NA
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0.25 mg/kg
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ª If neutropenia is the only toxicity at any dose level, add granulocyte colony stimulating factor (G-CSF) and maintain the dose level of lenalidomide
• Thrombocytopenia
|
When platelets
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Recommended course
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|
First fall to < 25 x 10
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