- Active ingredient
- fludarabine
- Strength
- 10 mg
- Form
- tablet
- Manufacturer
- soficopharm
- Route
- oral.solid
Uses
Indicated for the treatment of adult patients with B-cell chronic lymphocytic leukemia (CLL) who have not responded to, or whose disease has progressed after, at least one standard alkylating-agent-containing regimen.
Do not use if
No absolute contraindications per current labeling. Use with extreme caution in patients with severe renal impairment, pre-existing bone marrow suppression, or history of autoimmune hemolytic anemia. Not recommended in combination with pentostatin due to severe pulmonary toxicity.
Side effects
Very common adverse reactions include myelosuppression (neutropenia, thrombocytopenia, anemia), fever, chills, infection, nausea, and vomiting. Serious effects include severe bone marrow suppression, autoimmune hemolytic anemia, opportunistic infections, CNS toxicity, and pulmonary toxicity.
Warnings
Must be administered under supervision of a physician experienced in antineoplastic therapy. Can severely suppress bone marrow function. Risk of severe and potentially fatal CNS toxicity, autoimmune hemolytic anemia, and serious pulmonary toxicity. Patients should be monitored closely for signs of hematologic and neurological toxicity.
How it works
Fludarabine phosphate is rapidly dephosphorylated to 2-fluoro-ara-A, then phosphorylated intracellularly by deoxycytidine kinase to the active triphosphate form (2-fluoro-ara-ATP), which inhibits DNA polymerase alpha, ribonucleotide reductase, and DNA primase, thereby blocking DNA synthesis and inducing apoptosis in malignant lymphocytes.
Storage
Store refrigerated between 2–8°C (36–46°F). Handle as a cytotoxic agent with appropriate precautions for disposal.
