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Fludarabine Phosphate

Also known as: Fludarabine Phosphate

Route: Intravenous

Check Fludarabine Phosphate Interactions →

1 interaction on record⛔ Black Box Warning

Fludarabine Phosphate has 1 known drug interaction based on U.S. FDA drug labeling data. Of these, 1 are contraindicated combinations that should be avoided entirely. Notable interactions include combinations with Pentostatin. Patients taking Fludarabine Phosphate should inform their healthcare provider of all current medications — including over-the-counter drugs and supplements — to avoid potentially harmful combinations. Data sourced from OpenFDA and the NIH National Library of Medicine.

Total: 1
Contraindicated: 1

Contraindicated (1)

Fludarabine Phosphate + Pentostatin— Combined use not recommended due to increased risk of fatal pulmonary toxicity.

Fludarabine Phosphate + Pentostatin⛔Contraindicated

Combined use not recommended due to increased risk of fatal pulmonary toxicity.

⛔ FDA Black Box Warning

WARNING: Fludarabine Phosphate for Injection should be administered under the supervision of a qualified physician experienced in the use of antineoplastic therapy. Fludarabine Phosphate for Injection can severely suppress bone marrow function. When used at high doses in dose-ranging studies in patients with acute leukemia, Fludarabine Phosphate for Injection was associated with severe neurologic effects, including blindness, coma, and death. This severe central nervous system toxicity occurred in 36% of patients treated with doses approximately four times greater (96 mg/m 2 /day for 5 to 7 days) than the recommended dose. Similar severe central nervous system toxicity, including coma, seizures, agitation and confusion, has been reported in patients treated at doses in the range of the dose recommended for chronic lymphocytic leukemia. Instances of life-threatening and sometimes fatal autoimmune phenomena such as hemolytic anemia, autoimmune thrombocytopenia/thrombocytopenic purpura (ITP), Evans syndrome, and acquired hemophilia have been reported to occur after one or more cycles of treatment with Fludarabine Phosphate for Injection. Patients undergoing treatment with Fludarabine Phosphate for Injection should be evaluated and closely monitored for hemolysis. In a clinical investigation using Fludarabine Phosphate for Injection in combination with pentostatin (deoxycoformycin) for the treatment of refractory chronic lymphocytic leukemia (CLL), there was an unacceptably high incidence of fatal pulmonary toxicity. Therefore, the use of Fludarabine Phosphate for Injection in combination with pentostatin is not recommended.

Contraindications

CONTRAINDICATIONS Fludarabine Phosphate for Injection is contraindicated in those patients who are hypersensitive to this drug or its components.

Pregnancy & Breastfeeding

Pregnancy (See WARNINGS section). Based on its mechanism of action, fludarabine phosphate can cause fetal harm when administered to a pregnant woman. There are not adequate and well-controlled studies of fludarabine phosphate in pregnant women. Fludarabine phosphate was embryolethal and teratogenic in rats and rabbits. If Fludarabine Phosphate for Injection is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant. In rats, repeated intravenous doses of fludarabine phosphate at 2.4 times and 7.2 times the recommended human IV dose (25 mg/m 2 ) administered during organogenesis caused an increase in resorptions, skeletal and visceral malformations (cleft palate, exencephaly, and fetal vertebrae deformities) and decreased fetal body weights. Maternal toxicity was not apparent at 2.4 times the human IV dose, and was limited to slight body weight decreases at 7.2 times the human IV dose. In rabbits, repeated intravenous doses of fludarabine phosphate at 3.8 times the human IV dose administered during organogenesis increased embryo and fetal lethality as indicated by increased resorptions and a decrease in live fetuses. A significant increase in malformations including cleft palate, hydrocephaly, adactyly, brachydactyly, fusions of the digits, diaphragmatic hernia, heart/great vessel defects, and vertebrae/rib anomalies were seen in all dose levels (≥0.5 times the human IV dose).

Data sourced from U.S. FDA drug labeling via openFDA and the NIH National Library of Medicine. For informational purposes only. Always consult your pharmacist or physician.