Advice

Following a full submission

Fludarabine phosphate (Fludara) is accepted for restricted use within NHS Scotland for the treatment of B-cell chronic lymphocytic leukaemia (CLL) in patients with sufficient bone marrow reserves. First line treatment should only be initiated in patients with advanced disease, Rai stages III/IV (Binet stage C), or Rai stages I/II (Binet stage A/B) where the patient has disease related symptoms or evidence of progressive disease.

Fludarabine phosphate has been associated with higher response rates than chlorambucil in clinical trials. No overall survival advantage over other therapies has been demonstrated.

Fludarabine is restricted to use by specialists in haemato-oncology.

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Medicine details

Medicine name:
fludarabine, 10mg tablet and 50mg for injection or infusion (Fludara)
SMC ID:
176/05
Indication:
B-cell chronic lymphocytic leukaemia
Pharmaceutical company
Schering Health Care Ltd
BNF chapter
Malignant disease and immunosuppression
Submission type
Full
Status
Restricted
Date advice published
13 November 2006