Fludarabine
- Atc Codes:L01BB05
- CAS Codes:75607-67-9#21679-14-1
- PHARMGKB ID:75607-67-9#21679-14-1
Table of contents
- Brand Names
- Chemistry
- Pharmacologic Category
- Mechanism of Action
- Therapeutic Use
- Unlabeled Use
- Pregnancy and Lactation Implications
- Contraindications
- Warnings and Precautions
- Adverse Reactions
- Genes that may be involved
- Drug Interactions
- Nutrition/Nutraceutical Interactions
- Dosage
- Pharmacokinetics and Pharmacodynamics
- Special Considerations
Brand Names
Europe
Austria: Fludara, Fludarabin, Neoflubin; Belgium: Fludara, Fludarabine; Bulgaria: Fludara; Cyprus: Fludara; Czech Republic: Fludara, Fludarabin, Fludarabine, Tazumara; Denmark: Fludara; Estonia: Fludara, Fludarabine; Finland: Fludara; France: Fludara, Fludarabine; Germany: Fludara, Fludarabin, Neoflubin; Greece: Fludara, Fludarabine; Hungary: Fludara, Fludarabin, Fludarabine; Ireland: Fludara, Fludarabine; Italy: Fludara, Fludarabina; Latvia: Fludara, Fludarabin, Fludarabine; Lithuania: Fludara, Fludarabin, Fludarabine; Luxembourg: Fludara; Malta: Fludara; Netherlands: Fludara, Fludarabine; Poland: Fludalym, Fludara, Fludarabin, Fludarabine; Portugal: Fludara, Fludarabina; Romania: Fludara, Fludarabina; Slovakia: Fludara, Fludarabin, Fludarabine; Slovenia: Fludara, Fludarabin; Spain: Beneflur, Fludarabina; Sweden: Fludara, Fludarabin; UK: Fludara, Fludarabine.
North America
Canada: Fludara, Fludarabine; USA: Fludara, Fludarabine, Oforta.
Latin America
Argentina: Fludakebir, Fludara, Fludarabina, Fluradosa, Florclina; Brazil: Fludara; Mexico: Beneflur.
Asia
Japan: Fludara.
Drug combinations
Chemistry
Fludarabine Phosphate: C~10~H~13~FN~5~O~7~P. Mw: 365.21. (1) 9H-Purin-6-amine, 2-fluoro-9-(5-O-phosphono-β-D-arabinofuranosyl)-; (2) 9-β-D-Arabinofuranosyl-2-fluoroadenine 5′-(dihydrogen phosphate). CAS-75607-67-9; CAS-21679-14-1 (fludarabine)(1982).
Pharmacologic Category
Antineoplastic Agents; Antimetabolites. (ATC-Code: L01BB05).
Mechanism of action
Fludarabine inhibits DNA synthesis by inhibition of DNA polymerase, ribonucleotide reductase and DNA primase.
Therapeutic use
Treatment of chronic lymphocytic leukemia (CLL)(including refractory CLL). Treatment of low-grade, refractory non-Hodgkin lymphoma.
Pregnancy and lactiation implications
There are no adequate, controlled studies in pregnant women. Should be used during pregnancy only in life-threatening situations or severe disease for which safer drugs cannot be used or are ineffective. Not recommended during lactation.
Unlabeled use
Treatment of non-Hodgkin lymphoma. Refractory acute leukemias and solid tumors (in pediatric patients). Waldenström’s macroglobulinemia. Reduced-intensity conditioning regimens prior to allogeneic hematopoietic stem cell transplantation.
Contraindications
Hypersensitivity of fludarabine or any component of the formulation. Severe renal impairment (CrCl <30 mL/minute). Decompensated hemolytic anemia. Pregnancy. Breast-feeding women. Concurrent use with pentostatin.
Warnings and precautions
Hazardous agent. Life-threatening (and sometimes fatal) autoimmune effects, including hemolytic anemia, autoimmune thrombocytopenia/thrombocytopenic purpura, Evans syndrome, and acquired hemophilia occurred. Severe bone marrow suppression (anemia, thrombocytopenia, and neutropenia) might occur. Higher than recommended doses associated with severe neurologic toxicity (blindness, coma, death). Progressive multifocal leukoencephalopathy (usually fatal) due to JC virus reported with use. May cause tumor lysis syndrome. Use with caution in pre-existing CNS disorder (epilepsy), spasticity, or peripheral neuropathy, pre-existing hematological disorders (particularly granulocytopenia), infection or fever, or in renal impairment (avoid use with CrCl <30 mL/minute). Do not use in combination with pentostatin (may lead to severe, even fatal pulmonary toxicity). Avoid vaccination with live vaccines during and after fludarabine treatment.