Antineoplastic Agents: Miscellaneous
OTASI1 “Tasigna capsule” 200 mg/cap
OTASI2 “Tasigna capsule” 150 mg/cap
適應症：治療慢性期及加速期費城染色體(Philadelphia chromosome)陽性的慢性骨髓性白血病(CML)成年患者，且該患者至少有過一次對先前的治療(包括imatinib)有阻抗性或耐受性不良的經驗。
Usual dose:
Philadelphia chromosome positive chronic myelogenous leukemia, Accelerated phase, Resistant or intolerant to prior therapy：
400 mg orally twice daily, approximately 12 hours apart on an empty stomach (avoid food for 2 hours before and 1 hour after taking nilotinib)
Philadelphia chromosome positive chronic myelogenous leukemia, Chronic phase, newly diagnosed：
300 mg orally twice daily, approximately 12 hours apart on an empty stomach (avoid food for 2 hours before and 1 hour after taking nilotinib)
Philadelphia chromosome positive chronic myelogenous leukemia, Chronic phase, resistant or intolerant to prior therapy：
400 mg ORALLY twice daily, approximately 12 hours apart on an empty stomach (avoid food for 2 hours before and 1 hour after taking nilotinib)
Adverse effect:
Common: peripheral edema, alopecia, night sweats, pruritus, rash, hyponatremia, hypophosphatemia, serum cholesterol raised, serum triglycerides raised, abdominal pain, constipation, diarrhea, nausea, upper abdominal pain, vomiting, arthralgia, muscle weakness, myalgia, spasm, muscle, asthenia, headache, cough, nasopharyngitis, fatigue
Serious: ischemic heart disease, myocardial infarction, peripheral arterial occlusive disease, prolonged QT interval, decreased albumin, hyperglycemia, hypokalemia, gastrointestinal hemorrhage, increased serum lipase level, anemia, febrile neutropenia, hemorrhage, leukopenia, neutropenia, thrombocytopenia, ALT/SGPT level raised, AST/SGOT level raised, Serum bilirubin raised, pneumonia, fever.
健保使用規範：
9.32.1.Nilotinib 200mg (如Tasigna 200mg) （98/6 /1、99/1/1、104/12/1）
1.限用於治療對imatinib 400MG (含)以上耐受性不良或治療無效的「慢性期或加速期費城染色體(Philadelphia chromosome) 陽性的慢性骨髓性白血病(CML)成年患者」。
2.必須檢附耐受性不良或治療無效的證明。(104/12/1)
3.Nilotinib與dasatinib不得合併使用。
9.32.2.Nilotinib 150mg (如Tasigna 150mg) ：(101/7/1、104/12/1)
限用於新確診之慢性期費城染色體陽性的慢性骨髓性白血病。(104/12/1)