Active Ingredient: Fludarabine
Treatment of B-cell chronic lymphocytic leukaemia (CLL) in adult patients with sufficient bone marrow reserves.
First line treatment with Fludara should only be initiated in adult 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.
For this indication, competent medicine agencies globally authorize below treatments:
Intravenous
25 - 25 mg per m² of body surface area (BSA)
From 25 To 25 mg per m² of body surface area (BSA) once every day for 5 day(s)
The recommended dose is 25 mg fludarabine phosphate/m² body surface area given daily for 5 consecutive days every 28 days by intravenous route. Each vial is to be made up in 2 ml water for injection. Each ml of the resulting solution will contain 25 mg fludarabine phosphate.
The required dose (calculated on the basis of the patient’s body surface area) of the reconstituted solution is drawn up into a syringe. For intravenous bolus injection this dose is further diluted in 10 ml sodium chloride 9 mg/ml (0.9%). Alternatively, for infusion, the required dose drawn up in a syringe may be diluted in 100 ml sodium chloride 9 mg/ml (0.9%) and infused over approximately 30 minutes.
The duration of treatment depends on the treatment success and the tolerability of the drug.
In CLL patients, fludarabine should be administered up to the achievement of best response (complete or partial remission, usually 6 cycles) and then the drug should be discontinued.
Infusion over approximately 30 minutes.
Oral
40 - 40 mg per m² of body surface area (BSA)
From 40 To 40 mg per m² of body surface area (BSA) once every day for 5 day(s)
The recommended dose is 40 mg fludarabine phosphate/m² body surface given daily for 5 consecutive days every 28 days by oral route. This dose corresponds to 1.6 times the recommended intravenous dose of fludarabine phosphate (25 mg/m² body surface per day).
The following table provides guidance for determining the number of tablets of fludarabine oral to be administered:
| Body Surface Area (BSA) [m²] | Calculated total daily dose based on BSA (rounded up or down to whole number) [mg/day] | Number of tablets per day (total daily dose) |
|---|---|---|
| 0.75-0.88 | 30–35 | 3 (30 mg) |
| 0.89-1.13 | 36–45 | 4 (40 mg) |
| 1.14-1.38 | 46–55 | 5 (50 mg) |
| 1.39-1.63 | 56–65 | 6 (60 mg) |
| 1.64-1.88 | 66–75 | 7 (70 mg) |
| 1.89-2.13 | 76–85 | 8 (80 mg) |
| 2.14-2.38 | 86–95 | 9 (90 mg) |
| 2.39-2.50 | 96–100 | 10 (100 mg) |
The duration of treatment depends on the success of treatment and the tolerability of the drug. Fludarabine oral should be administered until best response is achieved (complete or partial remission, usually 6 cycles) and then the drug should be discontinued.
Dose adjustments for the first treatment cycle (start of therapy with fludarabine) are not recommended.
Patients undergoing treatment with fludarabine should be closely monitored for response and toxicity.
Individual dosing should be carefully adjusted according to the observed haematological toxicity.
If at the start of a subsequent cycle cell numbers are too low to administer the recommended dosage and there is evidence of treatment associated myelosuppression, the planned treatment cycle should be postponed until granulocyte count is above 1.0 × 109/L and platelet count is above 100 × 109/L. Treatment should only be postponed up to a maximum of two weeks. If granulocyte and platelet counts have not recovered after two weeks of postponement, the dose should be reduced according to the suggested dose adjustments in the table below.
| Granulocytes and/or Platelets [109/L] | Fludarabine phosphate dose | |
|---|---|---|
| 0.5-1.0 | 50-100 | 30 mg/m²/day |
| <0.5 | ><50 | 20 mg/m²/day |
Dose should not be reduced if thrombocytopenia is disease related.
If a patient does not respond to treatment after two cycles and shows no or little haematological toxicity a careful dose adjustment towards higher fludarabine phosphate doses in subsequent treatment cycles could be considered.
Fludarabine oral can be taken either on an empty stomach or together with food.
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