Nanoxel Special Precautions

Hematology: Nanoxel therapy should not be administered to patients with baseline neutrophil counts of <1500 cells/mm³. In order to monitor the occurrence of myelotoxicity, it is recommended that frequent peripheral blood cell counts be performed on all patients receiving Nanoxel. Patients should not be retreated with subsequent cycles of Nanoxel until neutrophils recover to a level >1500 cells/mm³ and platelets recover to a level >100,000 cells/mm³. In the case of severe neutropenia (<500 cells/mm³ ≥7 days) during a course of Nanoxel therapy, a 25% reduction in dose for subsequent courses of therapy is recommended. (See Dosage & Administration).
Nervous System: Sensory neuropathy occurs frequently with Nanoxel. The occurrence of grade 1 or 2 sensory neuropathy does not generally require dose modification. If grade 3 sensory neuropathy develops, treatment should be witheld until resolution to grade 1 or 2 followed by a dose reduction for all subsequent courses of Nanoxel (see Dosage & Administration).
Injection Site Reaction: Injection site reactions occur infrequently with Nanoxel and were mild in severity. Given the possibility of extravasation, it is advisable to closely monitor the infusion site for possible infiltration during drug administration.
Carcinogenicity, Mutagenicity & Impairment of Fertility: The carcinogenic potential of Nanoxel has not been studied. Paclitaxel has been shown to be clastogenic in vitro (chromosome aberrations in human lymphocytes) and in vivo (micronucleus test in mice) paclitaxel was not mutagenic in the Ames test or the CHO/HGPRT gene mutation assay.
Use in pregnancy: Pregnancy Category D: There are no adequate and well-controlled studies in pregnanct women. If Nanoxel is used during pregnancy or if the patient becomes pregnant while receiving Nanoxel, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant.
Use in lactation: It is not known whether paclitaxel is excreted in human milk. Following IV administration of carbon-14 labeled paclitaxel injection to rats on days 9-10 postpartum, concentrations of radioactivity in milk were higher than in plasma and declined in parallel with the plasma conentrations. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, it is recommended that nursing be discontinued when receiving Nanoxel therapy.
Use in children: The safety and effectiveness of Nanoxel in pediatric patients have not been established.