DCH Auriga
Concise Prescribing Info
In combination w/ dexamethasone for adults w/ multiple myeloma. Maintenance therapy in patients w/ multiple myeloma following autologous hematopoietic stem cell transplantation (auto-HSCT).
Dosage/Direction for Use
Newly diagnosed multiple myeloma Maintenance in patients who have undergone autologous stem cell transplantation Initially 10 mg once daily continuously on days 1-28 of repeated 28-day cycles given until disease progression or intolerance. After 3 cycles, may be increased to 15 mg once daily if tolerated. In combination w/ dexamethasone until disease progression in patients who are not eligible for transplant Initially lenalidomide 25 mg once daily on days 1-21 of repeated 28-day cycles w/ 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 w/ dexamethasone 40 mg once daily on days 1-4, 9-12 & 17-20 of each 28-day cycle for the first 4 cycles of therapy & then 40 mg once daily on days 1-4 every 28 days. End-stage renal disease CrCl <30 mL/min, requiring dialysis 5 mg once daily on days 1-21 of repeated 28-day cycles. On dialysis days, dose should be administered following dialysis. Severe renal impairment CrCl <30 mL/min, not requiring dialysis 15 mg every other day on days 1-21 of repeated 28-day cycles. Moderate renal impairment CrCl ≤30 to <50 mL/min 10 mg once daily on days 1-21 of repeated 28-day cycles. May be increased to 15 mg once daily after 2 cycles if patient is not responding to treatment.
May be taken with or without food: Swallow whole, do not break/chew/open.
Hypersensitivity. Women of childbearing potential. Pregnancy.
Special Precautions
Allergic reaction/hypersensitivity may occur; discontinue if exfoliative or bullous rash, or if Stevens-Johnson or toxic epidermal necrolysis occur. Women of childbearing potential must use 2 effective methods of contraception for 4 wk before, during & until 4 wk after therapy (even in case of dose interruption). Perform pregnancy test prior to starting treatment, & to be repeated every 4 wk, including 4 wk after treatment. Do not donate blood during therapy or for 4 wk following discontinuation. Patients w/ known risk factors of MI & thromboembolism including prior thrombosis. Concomitant use w/ combined OC pills & copper-releasing IUD are not recommended; erythropoietics or agents that may increase the risk of thrombosis eg, hormone replacement therapy; other myelosuppressive agents. Observe patients for signs & symptoms of thromboembolism; bleeding including petechiae & epistaxis especially in patients receiving concomitant drugs susceptible to induce bleeding. Perform CBC including WBC w/ differential count, platelet count, Hb & haematocrit at baseline every wk for the first 8 wk of treatment & mthly thereafter. Neutropenia & thrombocytopenia. Monitor thyroid function; liver function particularly when there is history of concurrent viral liver infection or concomitant w/ drugs known to be associated w/ liver dysfunction. Peripheral neuropathy. Patients at risk of tumour flare reaction & tumor lysis syndrome; previously infected w/ HBV including patients who are anti-HBc positive but HBsAg negative. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Secondary primary malignancies. Cataract may occur w/ prolonged use (in combination w/ dexamethasone. Male patients should use condoms throughout treatment duration, during dose interruption & 4 wk after cessation of treatment. Renal impairment. Minor or moderate influence on the ability to drive & use machines. Lactation. Patient >75 yr, ISS stage III, ECOG PS ≤2 or CrCl <60 mL/min.
Adverse Reactions
Pneumonia, lung infection; neutropenia, bronchitis, diarrhea, nasopharyngitis, muscle spasms, leucopenia, asthenia, cough, thrombocytopenia, gastroenteritis, pyrexia; rash, upper resp tract infection, fatigue, anemia; renal failure; back pain, asthenia, insomnia, decreased appetite; venous thromboembolism, grade 4 neutropenia; constipation.
Drug Interactions
Erythropoietic agents, other agents that may increase risk of thrombosis (eg hormone replacement therapy). May reduce efficacy of OCs. Warfarin (when in combination w/ dexamethasone). Increase plasma exposure of digoxin.
ATC Classification
L04AX04 - lenalidomide ; Belongs to the class of other immunosuppressants.
Revlimid hard cap 10 mg
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