Bone marrow suppression (primarily neutropenia) is dose dependent and a dose limiting toxicity . ABRAXANE should not be administered to patients with baseline neutrophil counts of 3 . Frequent monitoring of blood counts should be instituted during ABRAXANE treatment. Patients should not be retreated with subsequent cycles of ABRAXANE until neutrophils recover to a level > 1,500 cells/mm 3 and platelets recover to a level > 100,000 cells/mm 3 . The use of ABRAXANE has not been studied in patients with hepatic or renal dysfunction. In the randomized controlled trial , patients were excluded for baseline serum bilirubin > 1.5 mg/dL or baseline serum creatinine > 2 mg/dL. Pregnancy - Teratogenic Effects: Pregnancy Category D: ABRAXANE can cause fetal harm when administered to a pregnant woman. Administration of paclitaxel protein-bound particles to rats on gestation days 7 to 17 at doses of 6 mg/m 2 (approximately 2% of the daily maximum recommended human dose on a mg/m 2 basis) caused embryo- and fetotoxicity, as indicated by intrauterine mortality, increased resorptions (up to 5-fold), reduced numbers of litters and live fetuses, reduction in fetal body weight and increase in fetal anomalies. Fetal anomalies included soft tissue and skeletal malformations, such as eye bulge, folded retina, microphthalmia, and dilation of brain ventricles. A lower incidence of soft tissue and skeletal malformations were also exhibited at 3 mg/m 2 (approximately 1% of the daily maximum recommende
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