FLUDARA FOR INTRAVENOUS INJECTION 50 MG/VIAL [SIN11143P]

Product Info

FLUDARA FOR INTRAVENOUS INJECTION 50 MG/VIAL

[SIN11143P]

Therapeutic Indications
Treatment of B-cell chronic lymphocytic leukaemia (CLL) in patients with sufficient bone marrow reserves.
First line treatment with Fludara 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.

Posology and Method of Administration
Posology

• Adults
  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 (see also section Special Precautions for Disposal and Other Handling – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

  The required dose (calculated on the basis of the patient’s body surface) 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, Fludara should be administered up to the achievement of best response (complete or partial remission, usually 6 cycles) and then the drug should be discontinued.

Special populations

• 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 see section Special Warnings and Precautions for Use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
  Fludara treatment is contraindicated if creatinine clearance is < 30 ml/min (see section Contraindications).

• Patients with hepatic impairment
  No data are available concerning the use of Fludara in patients with hepatic impairment. In this group of patients, Fludara should be used with caution.

• Children
  The safety and efficacy of Fludara in children has not been established. Therefore, Fludara is not recommended for use in children.

• Elderly patients
  Since there are limited data for the use of Fludara in elderly persons (> 75 years), caution should be exercised with the administration of Fludara in these patients.

  In patients over the age of 65 years, creatinine clearance should be measured, see 'Patients with renal impairment' and section Special Warnings and Precautions for Use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

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

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

Precautions to be taken before handling the medicinal product
For instructions on handling and reconstitution of the medicinal product before administration, see section Special Precautions for Disposal and Other Handling – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Contraindications

• Hypersensitivity to fludarabine phosphate or to any of the excipients listed in section List of Excipients – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information

• Renal impairment with creatinine clearance < 30 ml/min

• Decompensated haemolytic anaemia

• Lactation