Multiple myeloma (MM), in combination with dexamethasone, in patients who have received at least one prior therapy. 與dexamethasone 合併使用可治療先前已接受至少一種治療失敗之多發性骨髓瘤
藥理
Lenalidomide is an analog of thalidomide with immunomodulatory, antiangiogenic, and antineoplastic properties. In vivo, lenalidomide delays tumor growth in some nonclinical hematopoietic tumor models, including multiple myeloma.
藥動學
Absorption: Effect of food: AUC decreased 20%, Cmax decreased 50%; Plasma Protein binding: approximately 30%; Excretion : Renal: 90% , Dialyzable: Yes (hemodialysis), 40% ; Elimination half-life : 3-5 hours in healthy subjects, and prolonged 3-fold in moderate or severe renal impairment.
禁忌症
pregnancy; high potential for birth defects; women of childbearing potential must take adequate precautions to prevent pregnancy; pregnancy testing required. Hypersensitivity to lenalidomide.
懷孕分類
X
哺乳分類
Avoided.
副作用
Most common adverse reactions (?20%) include fatigue, neutropenia, constipation, diarrhea, muscle cramp, anemia, pyrexia, peripheral edema, nausea, back pain, upper respiratory tract infection, dyspnea, dizziness, thrombocytopenia, tremor and rash.
劑量和給藥方法
The recommended initial dosage in adults is 10 mg once daily. Because lenalidomide is associated with substantial thrombocytopenia and neutropenia in patients with this condition, complete blood cell counts (CBCs) should be monitored weekly for the first 8 weeks of therapy and at least monthly thereafter. Therapy should be interrupted or dosage reduced accordingly.
小兒調整劑量
腎功能調整劑量
Dose adjustment in renal impairment:(Mantle cell lymphoma)
CrCl: 30-60 ml/min: initial dose 10 mg PO QD;
CrCl< 30ml/min (not requiring dialysis): initial dose 15 mg PO Q48H;
End stage Renal Impairment: CrCl; 30 ml/min (requiring dialysis): initial dose 5 mg PO QD, on dialysis days, administer the dose following dialysis.