ANZATAXTM (paclitaxel) should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available.
Severe hypersensitivity reactions characterised by dyspnoea, flushing, chest pain and tachycardia and hypotension requiring treatment, angioedema, and generalised urticaria have occurred in patients receiving ANZATAXTM. Patients receiving ANZATAXTM should be pretreated with corticosteroids, promethazine, and H2-antagonists to prevent these reactions (see DOSAGE AND DIRECTIONS FOR USE section). Patients who experience severe hypersensitivity reactions to ANZATAXTM should not be rechallenged with the drug.
ANZATAXTM therapy should not be given to patients with baseline neutrophil counts of less than 1500 cells/mm3. In order to monitor the occurrence of bone marrow suppression, primarily neutropenia, which may be severe and result in infection, it is recommended that frequent peripheral blood cell counts be performed on all patients receiving ANZATAXTM.
The polyoxyethylated castor oil in ANZATAXTM can result in phthalate leaching from polyvinyl chloride (PVC) containers, at levels which increase with time and concentration.
Consequently, the preparation, storage and administration of diluted ANZATAXTM should be carried out by using non-plasticised PVC-containing equipment.
|||The palliative treatment of stage 3 or 4 advanced local carcinoma of the ovary after surgical resection, in combination with cisplatin.|
|||The palliative management of metastatic carcinoma of the ovary after failure of first line or subsequent chemotherapy.|
|||The treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contra-indicated.|
|||Palliative treatment of advanced non-small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy.|