English Name
:
Andason Lyophilized Powder For Injection
Product Licence
:
衛部藥製字第058979號
Ingredients
:
Azacitidine
Dosage Form
:
Lyophilized Injection
Manufacturing Place
:
Taiwan
Indications
:
A nucleoside metabolic inhibitor indicated for the treatment of patients with the following FAB myelodysplastic syndrome (MDS) subtypes:
Refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL).
Dosage
:
The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology values, is 75 mg/m2 daily for 7 days to be administered by subcutaneous injection or intravenous infusion. Premedicate for nausea and vomiting.
Repeat cycles every 4 weeks. After 2 cycles, may increase dose to
100 mg/m2 if no beneficial effect is seen and no toxicity other than
nausea and vomiting has occurred. Patients should be treated for a
minimum of 4 to 6 cycles. Complete or partial response may require
additional treatment cycles.
Continue treatment as long as the patient continues to benefit.
Monitor patients for hematologic response and for renal toxicity; delay
or reduce dosage as appropriate.
NHI. Effective Date
:
107.05.01
Licence Expire Day
:
109/12/08
Product Code
:
4170002115815