Fludara

Fludara 50 mg injection is administered intravenously (IV) over approximately 30 minutes. It must be diluted prior to use. Strict aseptic technique should be followed during preparation and administration.

Fludarabine phosphate is rapidly dephosphorylated to 2-fluoro-ara-A, which is then phosphorylated intracellularly to the active triphosphate, 2-fluoro-ara-ATP. This active metabolite inhibits DNA polymerase alpha, beta, and epsilon, ribonucleotide reductase, and DNA primase, thereby inhibiting DNA synthesis and repair. It also inhibits RNA synthesis. This leads to disruption of cell growth and ultimately induces apoptosis in malignant lymphocytes.

• Severe renal impairment (creatinine clearance < 30 mL/min).
• Patients with decompensated hemolytic anemia.
• Known hypersensitivity to fludarabine or its components.
• Pregnancy and lactation.

Store intact vials refrigerated at 2°C to 8°C (36°F to 46°F). Protect from light. Do not freeze. Reconstituted solution should be used promptly.

Symptoms of overdose include severe myelosuppression, neurotoxicity (e.g., blindness, coma, death), and severe immunosuppression. There is no specific antidote. Management involves supportive care, including blood transfusions, antibiotics for infection, and hematopoietic growth factors if needed.

Pregnancy Category D. Fludarabine can cause fetal harm when administered to a pregnant woman. Avoid during pregnancy. Women of childbearing potential should be advised to avoid becoming pregnant and to use effective contraception. It is not known whether fludarabine or its metabolites are excreted in human milk; therefore, breastfeeding is contraindicated.

• Severe renal impairment (creatinine clearance < 30 mL/min).
• Patients with decompensated hemolytic anemia.
• Known hypersensitivity to fludarabine or its components.
• Pregnancy and lactation.

Store intact vials refrigerated at 2°C to 8°C (36°F to 46°F). Protect from light. Do not freeze. Reconstituted solution should be used promptly.

Symptoms of overdose include severe myelosuppression, neurotoxicity (e.g., blindness, coma, death), and severe immunosuppression. There is no specific antidote. Management involves supportive care, including blood transfusions, antibiotics for infection, and hematopoietic growth factors if needed.

Pregnancy Category D. Fludarabine can cause fetal harm when administered to a pregnant woman. Avoid during pregnancy. Women of childbearing potential should be advised to avoid becoming pregnant and to use effective contraception. It is not known whether fludarabine or its metabolites are excreted in human milk; therefore, breastfeeding is contraindicated.