Calitaxel (Paclitaxel) is a natural product isolated from Pacific Yew, Taxus brevifolia, the first of a new class of anticancer agents known as taxanes. Paclitaxel is a novel antimicrotubule agent that promotes the assembly of microtubules from tubulin dimers. It stabilises microtubules by preventing depolymerisation resulting in the inhibition of the normal dynamic reorganisation of the microtubule network essential for cellular functions. Paclitaxel also induces abnormal arrays or "bundles" of microtubules throughout the cell cycle and multiple asters of microtubules during mitosis.
In first line chemotherapy of ovarian cancer, paclitaxel is indicated for the treatment of patients with advanced disease or a residual disease (> 1cm) after initial laparotomy, in combination with cisplatin.
In second-line chemotherapy of ovarian cancer, paclitaxel is indicated in the treatment of metastatic carcinoma of the ovary after failure of standard platinum based therapy.
In the adjuvant setting, paclitaxel is indicated for the treatment of patients with node-positive breast carcinoma following doxorubicin and cyclophosphamide therapy.
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.
Paclitaxel, in combination with cisplatin, is indicated for the first-line treatment of non-small cell lung cancer in patients who are not candidates for potentially curative surgical intervention and/or radiation therapy.
Paclitaxel is indicated for the treatment of patients with advanced AIDS-related Kaposi's sarcoma who have failed prior liposomal anthracycline therapy.
Paclitaxel is contra-indicated in patients who have a history of severe hypersensitivity reactions to paclitaxel or one of the other ingredients of the product. Paclitaxel should not be used in patients who, at the start of the therapy, have a neutrophilic granulocyte count of <1500/mm3 or in patients with AIDS-related Kaposi’s sarcoma with neutrophil counts of <1000 cells/mm3.
Pregnancy: Paclitaxel has been shown to be both foetotoxic and embryotoxic, and to reduce fertility in animal studies. No information is available on the use of Paclitaxel in pregnant women. Paclitaxel may damage the foetus if administered to pregnant women. Paclitaxel is contra-indicated during pregnancy. Women should be advised not to fall pregnant during the treatment with Paclitaxel and they should immediately inform their physician in attendance if this should happen nevertheless.
Lactation: It is not known whether Paclitaxel is being secreted in the mother's milk. Paclitaxel is contra-indicated during lactation. Breast-feeding should be stopped during the treatment with Paclitaxel.
Storage: Store the vials in original cartons below 25oC. Protect from light. Neither freezing nor refrigeration adversely affects the stability of the product. Upon refrigeration, components in the Paclitaxel vial may precipitate, but will redissolve upon reaching room temperature with little or no agitation. There is no impact on product quality under these circumstances. If the solution remains cloudy or if an insoluble precipitate is noted, the vial should be discarded.
Shelf life: 24 months from manufacturing date. Do not use the drug after the expired date.
Package:
Strength Pack size
10 milligrams/16 mL vial 1
150 milligrams/25 mL vial 1
