Lenli

Monotherapy for maintenance treatment of adult patients w/ newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation (ASCT). Combination therapy w/ dexamethasone for adult patients w/ previously untreated multiple myeloma who are ineligible for transplant; for multiple myeloma in adult patients who have received at least 1 prior therapy.

Newly diagnosed multiple myeloma Patient who has undergone ASCT Maintenance: Initially 10 mg once daily continuously (on days 1-28 of repeated 28-day cycles) given until disease progression or intolerance. May increase to 15 mg once daily if tolerated after 3 cycles of lenalidomide maintenance. Patient ineligible for transplant In combination w/ dexamethasone: Initially lenalidomide 25 mg once daily on days 1-21 of repeated 28-day cycles. Dexamethasone 40 mg once daily on days 1, 8, 15 & 22 of repeated 28-day cycles. Multiple myeloma w/ at least 1 prior therapy Initially lenalidomide 25 mg once daily on days 1-21 of repeated 28-day cycles. Dexamethasone 40 mg once daily on days 1-4, 9-12 & 17-20 of each 28-day cycle for 1st 4 cycles & then 40 mg once daily on days 1-4 every 28 days. Multiple myeloma Moderate renal impairment (CrCl ≤30-<50 mL/min) 10 mg once daily (dose adjustment: days 1-21 of repeated 28-day cycles). May escalate to 15 mg once daily after 2 cycles if patient is not responding to & is tolerating treatment. Severe renal impairment (CrCl <30 mL/min not requiring dialysis) 15 mg every other day (dose adjustment: days 1-21 of repeated 28-day cycles). ESRD (CrCl <30 mL/min requiring dialysis) 5 mg once daily (dose adjustment: days 1-21 of repeated 28-day cycles). Administer dose following dialysis on dialysis days.

May be taken with or without food: Swallow whole, preferably w/ water; do not open/break/chew.

Hypersensitivity. Women of childbearing potential unless all Pregnancy Prevention Programme conditions are met. Pregnancy.

Cancer Immunotherapy / Immunosuppressants

L04AX04 - lenalidomide ; Belongs to the class of other immunosuppressants.

POM