Some of the views expressed in the following notes on newly approved products should be regarded as preliminary, as there may have been limited published data at the time of publication, and little experience in Australia of their safety or efficacy. However, the Editorial Executive Committee believes that comments made in good faith at an early stage may still be of value. Before new drugs are prescribed, the Committee believes it is important that more detailed information is obtained from the manufacturer's approved product information, a drug information centre or some other appropriate source.

Fludara (Schering)
vials containing 50 mg fludarabine
Indication: chronic lymphocytic leukaemia

This product is an analogue of the antiviral drug vidarabine. Fludarabine inhibits DNA synthesis and reduces protein synthesis. As there are significant adverse effects, fludarabine is only approved for use as second line therapy in patients who have not responded to alkylating agents.

Fludarabine is given intravenously for 5 consecutive days in every 28 days. The drug is dephosphorylated, then taken into the cells where it is rephosphorylated to its active metabolite. Excretion is mainly by the kidneys and so the dosage needs to be reduced if renal function is moderately reduced. The drug is contra indicated if renal function is greatly reduced (creatinine clearance <30mL/minute).

Patients with chronic lymphocytic leukaemia who have been treated previously may be more likely to respond to fludarabine than a combination of cyclophosphamide, adriamycin and prednisone. However, fludarabine may have more adverse effects and the optimal use of the drug is not yet known.

Adverse effects include neutropenia, thrombocytopenia, anaemia, peripheralneuropathy, tumourlysis syndrome, pulmonary hypersensitivity reactions and toxic epidermal necrolysis. Some patients have died as a result of serious adverse reactions. Toxicity may be increased with age and by renal insufficiency, hypoalbuminaemia, anaemia or thrombocytopenia.