SAMOH Pharm CO., LTD. & SAMOH Pharmachem CO., LTD.

Fludarabine phosphate injection is indicated to the first-line therapy or second-line therapy of patients with B-Cell chronic lymphocytic leukemia (CLL) who have enough bone marrow.

First line treatment with Fludarabine 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.

- Deterioration of bone marrow failure

- Weight loss, extreme fatigue, at night sweating or fever

- Huge or progressive hepatosplenomegaly or lymphadenopathy patients

- A peripheral blood lymphocyte has been increased more than 50% during 2 months or it has been increased two times within 12 months.

Fludarabine phosphate injection is indicated for second line therapy in patients with low grade non-Hodgkin’s lymphoma (Lg-NHL) who have failed other conventional therapies.

Fludarabine should be administered under the supervision of a qualified physician experienced in the use of antineoplastic therapy.

It is strongly recommended that Fludarabine should be only administered intravenously. No cases have been reported in which paravenously administered Fludarabine led to severe local adverse reactions. However, unintentional paravenous administration must be avoided.

Adult: 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.

Patients with renal impairment: 

Doses should be adjusted for patients with reduced kidney function. If creatinine clearance is between 30 and 70 ml/min, the dose should be reduced by up to 50% and close haematological monitoring should be used to assess toxicity.

Fludarabine treatment is contraindicated, if creatinine clearance is < 30 ml/min. 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