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See related Fludara information |
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Manufacturer |
Genzyme |
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Distributor |
Hong Kong: DKSH |
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Contents |
Fludarabine phosphate |
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Indications |
Treatment of patients w/ B-cell chronic lymphocytic leukaemia (CLL) w/ sufficient bone marrow reserve who have not responded to or whose disease has progressed during or after treatment w/ at least 1 standard alkylating-agent containing regimen. Vial Treatment of low grade non-Hodgkin's lymphoma at stage 3-4 in patients refractory to a standard therapy involving at least 1 alkylating agent or in whom the disease has progressed during or after the standard treatment. |
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Dosage |
Oral Adult 40 mg/m2 BSA daily for 5 consecutive days in every 28 days. IV 25 mg/m2 BSA daily for 5 consecutive days in every 28 days. |
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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/ CrCl <30 mL/min. Decompensated haemolytic anaemia. Pregnancy & lactation. |
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Special Precautions |
Closely observe for signs of neurologic side effects. 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. Tumour lysis syndrome. Monitor for signs of autoimmune haemolytic anaemia. Measure CrCl for renally impaired patients & those >70 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. |
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Adverse Drug Reactions |
Myelosuppression (neutropenia, thrombocytopenia & anaemia),infection including pneumonia, fever, nausea, vomiting & diarrhoea. Fatigue, weakness, stomatitis, malaise, anorexia, oedema, chills, peripheral neuropathy, visual disturbances & skin rashes.
View ADR Monitoring Form |
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Drug Interactions |
Combination w/ pentostatin is not recommended. Efficacy 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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ATC Classification |
L01BB05 - fludarabine ; Belongs to the class of antimetabolites, purine analogues. Used in the treatment of cancer. |
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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 powder for injection |
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Fludara (single dose) 50 mg x 5's |
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Manufacturer: |
Genzyme |
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Distributor: |
Hong Kong: DKSH |
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