Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1711
| Predicate | Object |
|---|---|
| rdf:type | |
| rdfs:label |
Fludarabine Phosphate (Injection, Solution, Concentrate)
|
| dailymed-instance:activeIng... | |
| dailymed-instance:boxedWarn... |
WARNING: CNS TOXICITY, HEMOLYTIC ANEMIA, AND PULMONARY TOXICITY: Fludarabine Phosphate Injection should be administered under the supervision of a qualified physician experienced in the use of antineoplastic therapy. Fludarabine phosphate can severely suppress bone marrow function. When used at high doses in dose-ranging studies in patients with acute leukemia, fludarabine phosphate 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 has been rarely (���0.2%) reported in patients treated at doses in the range of the dose recommended for chronic lymphocytic leukemia. [See Warnings and Precautions (5.1)
] Instances of life-threatening and sometimes fatal autoimmune hemolytic anemia have been reported to occur after one or more cycles of treatment with fludarabine phosphate. Patients undergoing treatment with Fludarabine Phosphate Injection should be evaluated and closely monitored for hemolysis. [See Warnings and Precautions (5.2)
] In a clinical investigation using fludarabine phosphate 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 Injection in combination with pentostatin is not recommended [See Warnings and Precautions (5.6)
]
|
| dailymed-instance:activeMoi... | |
| dailymed-instance:inactiveI... | |
| dailymed-instance:genericMe... |
Fludarabine Phosphate
|
| dailymed-instance:fullName |
Fludarabine Phosphate (Injection, Solution, Concentrate)
|
| dailymed-instance:represent... | |
| dailymed-instance:routeOfAd... | |
| dailymed-instance:name |
Fludarabine Phosphate
|