País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
Fludarabine Phosphate (UNII: 1X9VK9O1SC) (Fludarabine - UNII:P2K93U8740)
Sagent Pharmaceuticals
Fludarabine Phosphate
Fludarabine Phosphate 50 mg in 2 mL
PRESCRIPTION DRUG
Abbreviated New Drug Application
FLUDARABINE PHOSPHATE- FLUDARABINE PHOSPHATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION SAGENT PHARMACEUTICALS ---------- FLUDARABINE PHOSPHATE FOR INJECTION, USP (FOR IV USE ONLY) SAGENT RX ONLY WARNING: Fludarabine Phosphate for Injection, USP should be administered under the supervision of a qualified physician experienced in the use of antineoplastic therapy. Fludarabine Phosphate for Injection, USP can severely suppress bone marrow function. When used at high doses in dose- ranging studies in patients with acute leukemia, Fludarabine Phosphate for Injection, USP 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 /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, USP. Patients undergoing treatment with Fludarabine Phosphate for Injection, USP should be evaluated and closely monitored for hemolysis. In a clinical investigation using Fludarabine Phosphate for Injection, USP 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, USP in combination with pentostatin is not recommended. DESCRIPTION Fludarabine Phosphate for Injection, USP contains fludarabine phosphate, USP, a fluorinated nucleotide analog of the antiviral agent vidarabine, 9-β-D-ara Llegiu el document complet