Antineoplastic Agents: Miscellaneous
OSPRY1 “Sprycel FC tablet ” 50 mg/tab
OSPRY2 “Sprycel FC tablet” 20 mg/tab
適應症：治療新診斷的費城染色體陽性之慢性期慢性骨髓性白血病的成人。 治療患有慢性、加速或急性期慢性骨髓性白血病，且對先前含imatinib的治療有抗藥性或無耐受性的成人。 亦適用於患有費城染色體陽性急性淋巴性白血病，且對先前含imatinib的治療有抗藥性或無耐受性的成人。
Usual dose: PO
Adult：
Philadelphia chromosome-positive acute lymphoblastic leukemia, Resistant or intolerant to prior therapy：140mg qd.
Philadelphia chromosome positive chronic myelogenous leukemia, Accelerated phase, resistant or intolerant to prior therapy：140mg qd.
Philadelphia chromosome positive chronic myelogenous leukemia, Blastic phase, resistant or intolerant to prior therapy：140mg qd.
Philadelphia chromosome positive chronic myelogenous leukemia, Chronic phase, newly diagnosed ：100mg qd.
Philadelphia chromosome positive chronic myelogenous leukemia, Chronic phase, resistant or intolerant to prior therapy：100mg qd.
Pediatric：
Safety and efficacy have not been established in pediatric patients less than 18 years of age.
Precautions：
Cardiovascular events, including cardiac ischemia, cardiac related fluid retention, conduction abnormalities, arrhythmias, palpitations, and transient ischemic attacks, have been reported; monitoring recommended.
Adverse effect:
Body fluid retention, localized edema, superficial, rash, hypocalcemia, hypokalemia, hypophosphatemia, abdominal pain, diarrhea, nausea, vomiting, myelosuppression, musculoskeletal pain, headache, dyspnea, fatigue, fever.
健保使用規範： (98/1/1、102/4/1、104/12/1)
限用於
1.第一線使用(102/4/1、104/12/1)：治療新診斷的費城染色體陽性之慢性期慢性骨髓性白血病的成人。
2.第二線使用(104/12/1)：
(1)治療患有慢性、加速或急性期慢性骨髓性白血病，對先前經imatinib 400mg(含)以上治療後有抗藥性或無耐受性的成人。
(2)治療患有費城染色體陽性急性淋巴性白血病，且對先前經imatinib 400mg(含)以上治療後有抗藥性或無耐受性的成人。
(3)需檢送病歷及對imatinib耐受性不良或無效的證明(104/12/1)。