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See related Fludara information |
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Manufacturer |
Genzyme |
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Distributor |
DKSH |
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Contents |
Fludarabine phosphate |
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Indications |
Initial treatment of patients w/ B-cell chronic lymphocytic leukemia (CLL) & for patients w/ CLL who have not responded to or whose disease has progressed during or after treatment w/ at least 1 standard alkylating agent-containing regimen. Tab Low-grade or follicular B-cell non-Hodgkin's lymphoma, mantle cell lymphoma. Vial Patients w/ low-grade non-Hodgkin's lymphoma who have not responded to or whose disease has progressed during or after treatment w/ at least 1 standard alkylating agent-containing regimen. |
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Dosage |
Tab 40 mg/m2 body surface once daily for 5 consecutive days. Repeat 5-day course treatment after 28 days until up to 6 cycles. Vial 25 mg/m2 body surface given daily for 5 days in every 28 days by IV infusion over 30 min. |
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Administration |
May be taken with or without food (Swallow whole, do not break/chew/crush.). |
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Contraindications |
Renally impaired patients w/ creatinine clearance <30 mL/min. Hemolytic anemia. Pregnancy & lactation. |
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Special Precautions |
Severe bone marrow suppression (notably anaemia, thrombocytopenia & neutropenia) or myelosuppression may occur. Closely observe patients for signs of haematologic & non-haematologic toxicity. Periodic assessment of peripheral blood counts recommended to detect development of anaemia, neutropenia & thrombocytopenia. Monitor for signs of autoimmune haemolytic anaemia. Measure CrCl of renally impaired patients & those >75 yr. Caution in use in the elderly. Females of childbearing potential or males should take contraceptive measures for at least 6 mth after stopping therapy. Avoid live vaccines during & after treatment. Hepatic impairment. |
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Adverse Drug Reactions |
Commonly, myelosuppression, fever, chills, infection, malaise, fatigue, anorexia, nausea, vomiting, weakness, numb or weak limbs, visual problems, diarrhea, rash, edema, lung inflammation.
View ADR Monitoring Form |
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Drug Interactions |
Concomitant use w/ pentostatin not recommended. Effectiveness may be reduced by dipyridamole & other inhibitors of adenosine uptake.
View more drug interactions with Fludara |
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Pregnancy Category (US FDA) |
Category D: There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective). |
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Presentation/Packing |
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Form |
Packing |
Photo |
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Fludara film-coated tablet |
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Fludara 10 mg x 20's |
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Fludara infusion |
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Fludara 50 mg x 5's |
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Manufacturer: |
Genzyme |
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Distributor: |
DKSH
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