Paxoll Special Precautions

Note: Contact of the undiluted concentrate with plasticized PVC equipment or devices used to prepare solutions for infusion is not recommended. Diluted PAXOLL solutions should be stored in bottles (glass, polypropylene) and administered through polyethylene lined administration sets.
Hematology: PAXOLL therapy should not be administered to patients with baseline neutrophil counts of less than 1,500 cells/mm³. In case of severe neutropenia (<500 cells/mm³ during a course of Paxoll, a 20% reduction in dose for subsequent courses of therapy is recommended. In order to monitor the occurrence of myelotoxicity, it is recommended that frequent peripheral blood cell counts be performed on all patients receiving PAXOLL.
Preparation and Administration Precautions: PAXOLL is a cytotoxic anticancer drug, caution should be exercised in handling PAXOLL. The use of gloves is recommended. If PAXOLL solution comes in contact with the skin wash the area immediately and thoroughly with soap and water. If PAXOLL contacts mucous membranes, the membranes should be flushed thoroughly with water. Upon inhalation, dyspnea, chest pain, burning sensation in eyes, sore throat, and nausea have been reported.
Cardiovascular: Hypotension, bradycardia, and hypertension have been observed during administration of PAXOLL but generally do not require treatment. In severe cases, PAXOLL infusion may need to be interrupted of discontinued at the discretion of treating physician.
Nervous System: Although, the occurrence of peripheral neuropathy is frequent, the development of severe symptomatology is unusual PAXOLL contains dehydrated alcohol USP, 396 mg/mL; consideration should be given to possible CNS and other effects of alcohol.
Hepatic: There is evidence that the toxicity of PAXOLL is enhanced in patients with elevated liver enzymes. Caution should be exercised when administering PAXOLL. Patients with hepatic impairment may be at increased risk of toxicity particularly grade III-IV myelosuppression.
Carcinogenesis, Mutagenesis, Impairment of Fertility: The carcinogenic potential of PAXOLL has not been studied.
Paclitaxel has been shown to be clastogenic in vitro (chromosome aberration in human lymphocytes) and in vivo (micronucleus test in mice) Paclitaxel is not mutagenic in the Ames test or the CHO/HGPRT gene mutation assay. Administration of paclitaxel prior to and during mating produced impairment of fertility in male and female rats at doses equal to or greater than 1 mg/kg/day (about 0.04 the daily maximum recommended human dose on a mg/m² basis). At this dose, paclitaxel caused reduced fertility and reproductive indices, and increased embryo-and fetotoxicity.
Effect on ability to drive and to use machines: Since PAXOLL contains ethanol, consideration should be given to the possibility of CNS and other effects.
Use in Children: The safety and effectiveness of PAXOLL in pediatric patients have not been established. There have been reports of central nervous system toxicity.