FLUDARA ORAL
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Package:
TABLETS: 20.
Dosage:
40 mg/m² body surface given daily for 5 consecutive days every 28 days. Dose to be adjusted for patients with reduced renal function.
Prescribing Restrictions:
Indications:
Patients with B-cell chronic lymphocytic leukemia (CLL) with sufficient bone marrow reserve and who have not responded to or whose disease has progressed during or after treatment with at least one standard alkylating-agent containing regimen.
Contra-Indications:
Hypersensitivity to the drug or its components, renal impairment with a creatinine clearance of <30 ml/min, decompensated hemolytic anemia, pregnancy, lactation.
Special Precautions:
At high doses in dose-ranging studies in patients with acute leukemia, used intravenously, was associated with severe neurologic effects, including blindness, coma and death. Patients should be closely observed for signs of neurologic side effects. In patients with impaired state of health, treatment should be given with caution and after careful risk/benefit consideration. Observe closely for signs of hematologic and non-hematologic toxicity. Patients who require blood transfusion and who are undergoing, or who have received treatment, should receive irradiated blood only. Patients with large tumour burdens. Patients closely monitor for haemolysis. Closely monitor for signs of autoimmune haemolytic anaemia. Should not be used during pregnancy. Breast-feeding should be discontinued for the duration of therapy.
Side Effects:
Severe bone marrow suppression, notably anaemia, thrombocytopenia and neutropenia, myelosuppression, infection including pneumonia, fever, nausea, vomiting, diarrhea, fatigue, weakness, stomatitis, malaise, anorexia, oedema, chills, peripheral neuropathy, visual disturbances, and skin rashes.
Drug Interactions:
Live vaccines, pentostatin, dipyridamole and other inhibitors of adenosine uptake.
