Fludara 50 mg/2 ml (IV Infusion)

Indications

• Treatment of B-cell chronic lymphocytic leukemia (CLL)

Pharmacology

• Inhibition of DNA polymerase alpha
• Inhibition of ribonucleotide reductase
• Inhibition of DNA synthesis

Dosage & Administration

• Recommended daily dose of 25 mg/m² for 5 consecutive days every 28 days by intravenous route
• Oral tablet starting dose of 40 mg/m² once daily for five consecutive days every 28 days

Interaction

• Not recommended in combination with pentostatin
• Potential interaction with cytarabine

Contraindications

• Hypersensitivity to the active substance or excipients
• Renal impairment with creatinine clearance <30 ml/min
• Decompensated hemolytic anemia

Side Effects

• Bone marrow suppression
• Central nervous system problems
• Hemolytic anemia
• Lung toxicity when used in combination with pentostatin

Pregnancy & Lactation

• Limited data in pregnant women
• Premature delivery reported
• Not recommended during breastfeeding
• Potential transfer to human milk

Precautions & Warnings

• Associated with myelosuppression
• Irreversible CNS effects
• Auto-immune hemolytic anemia
• Fatal pulmonary toxicity in combination with pentostatin

Use in Special Populations

• Dosage adjustment for renal impairment

Therapeutic Class

• Cytotoxic Chemotherapy

Storage Conditions

• Store injection below 25°C
• In-use storage times should not exceed 24 hours at 2 to 8°C or 8 hours at room temperature
• Tablets should be stored between 15°C and 30°C
• Do not freeze
• Keep out of reach and sight of children

Related Brands

• Fludara 10 mg (Tablet) - genzyme-corporation
• Fludarabin Hexal 50 mg/2 ml (IV Infusion) - sandoz-a-novartis-division