Active Ingredient: Lenalidomide
Lenalidomide as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation.
Lenalidomide as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.
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:
Oral
10 - 25 mg
From 10 To 25 mg once every day
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.
Initial treatment: Lenalidomide in combination with bortezomib and dexamethasone:
Lenalidomide in combination with bortezomib and dexamethasone must not be started if the ANC is <1.0 × 109/L, and/or platelet counts are <50 × 109/L.
The recommended starting dose is lenalidomide 25 mg orally once daily days 1-14 of each 21-day cycle in combination with bortezomib and dexamethasone. Bortezomib should be administered via subcutaneous injection (1.3 mg/m² body surface area) twice weekly on days 1, 4, 8 and 11 of each 21-day.
Up to eight 21-day treatment cycles (24 weeks of initial treatment) are recommended.
Continued treatment: Lenalidomide in combination with dexamethasone until progression:
Continue lenalidomide 25 mg orally once daily on days 1-21 of repeated 28-day cycles in combination with dexamethasone. Treatment should be continued until disease progression or unacceptable toxicity.
Lenalidomide treatment must not be started if the ANC is <1.5 × 109/L, and/or platelet counts are <75 × 109/L.
Recommended dose: The recommended starting dose is lenalidomide 10 mg orally once daily on days 1 to 21 of repeated 28-day cycles for up to 9 cycles, melphalan 0.18 mg/kg orally on days 1 to 4 of repeated 28-day cycles, prednisone 2 mg/kg orally on days 1 to 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 monotherapy as follows: 10 mg orally once daily on days 1 to 21 of repeated 28-day cycles given until disease progression.
Lenalidomide maintenance should be initiated after adequate haematologic recovery following ASCT in patients without evidence of progression. Lenalidomide must not be started if the Absolute Neutrophil Count (ANC) is <1.0 × 109/L, and/or platelet counts are <75 × 109/L.
Recommended dose: The recommended starting dose is lenalidomide 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.
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