Revlimid 15 mg hard capsules
Each capsule contains 15 mg of lenalidomide.
Excipient(s) with known effect:
Each capsule contains 289 mg of lactose, anhydrous.
For the full list of excipients, see section 6.1.
Hard capsule.
Pale blue/white capsules, size 0, 21.7 mm, marked “REV 15 mg”.
Revlimid is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant (see section 4.2).
Revlimid in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.
Revlimid treatment should be supervised by a physician experienced in the use of anti-cancer therapies.
Posology
Newly diagnosed multiple myeloma
Lenalidomide in combination with dexamethasone until disease progression in patients who are not eligible for transplant
Lenalidomide treatment must not be started if the Absolute Neutrophil Counts (ANC) is < 1.0 x 109/L, and/or platelet counts are < 50 x 109/L.
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
|
|
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
|
NA
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• Thrombocytopenia
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When platelets
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Recommended course
|
|
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 dail |
