Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
docetaxel, Quantity: 20 mg
Fresenius Kabi Australia Pty Ltd
Docetaxel
Injection, concentrated
Excipient Ingredients: citric acid; polysorbate 80; ethanol absolute
Intravenous
Carton - 1's
(S4) Prescription Only Medicine
Breast Cancer,Metastatic Breast Cancer,Docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer in whom previous chemotherapy has failed.,Docetaxel in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior anthracycline containing chemotherapy.,Docetaxel in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease.,Adjuvant Treatment of Breast Cancer,Docetaxel in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with node-positive breast cancer.,Doxorubicin and cyclophosphamide followed by docetaxel in combination with trastuzumab (ACTH) is indicated for the adjuvant treatment of patients with operable breast cancer whose tumours overexpress HER2.,Docetaxel in combination with carboplatin and trastuzumab (TCH) is indicated for the adjuvant treatment of patients with operable breast cancer whose tumours overexpress HER2.,Docetaxel in combination with cyclophosphamide is indicated for the adjuvant treatment of operable breast cancer with a primary tumour of ?1cm and <7cm.,Non Small Cell Lung Cancer,Docetaxel is indicated for the treatment of patients with locally advanced or metastatic non small cell lung cancer, including those who have failed platinum-based chemotherapy.,Ovarian Cancer,Docetaxel is indicated for the treatment of metastatic carcinoma of the ovary after failure of firstline or subsequent chemotherapy.,Prostate Cancer,Docetaxel is indicated for the treatment of patients with androgen independent (hormone refractory) prostate cancer.,Head and Neck Cancer,Docetaxel, in combination with cisplatin and fluorouracil is indicated as induction treatment prior to chemoradiotherapy, for the treatment of patients with locally advanced, squamous cell carcinoma of the head and neck, who have low probability of surgical cure, require organ preservation or where the tumour is technically unresectable.
Visual Identification: Colourless to pale yellow solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2014-10-21
CMI for Docetaxel Kabi Feb, 2013 Page 1 of 4 DOCETAXEL KABI Docetaxel CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Docetaxel Kabi. It does not contain all the available information. It does not take the place of talking to your doctor, nurse or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you being given this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR DOCTOR, NURSE OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT DOCETAXEL KABI IS USED FOR Docetaxel Kabi is used to treat breast cancer, ovarian cancer, some types of lung cancer, head and neck cancer and prostate cancer. Docetaxel Kabi works by stopping cells from growing and multiplying. Docetaxel Kabi belongs to a group of medicines called antineoplastic or cytotoxic medicines. You may also hear of these being called chemotherapy medicines. Your doctor, however, may prescribe Docetaxel Kabi for another purpose. ASK YOUR DOCTOR, NURSE OR PHARMACIST IF YOU HAVE ANY QUESTIONS ABOUT WHY DOCETAXEL KABI HAS BEEN PRESCRIBED FOR YOU. You may have probably taken another medicine to treat your breast, ovarian, lung, head and neck or prostate cancer. However, your doctor has now decided to treat you with Docetaxel Kabi. Docetaxel Kabi may be used alone or in combination with other medicines to treat cancer. This medicine is only available with a doctor’s prescription. Docetaxel Kabi is not addictive. BEFORE YOU ARE GIVEN DOCETAXEL KABI _WHEN YOU MUST NOT BE GIVEN IT _ Docetaxel Kabi is not recommended for use in children. DO NOT RECEIVE DOCETAXEL KABI IF YOU HAVE AN ALLERGY TO DOCETAXEL OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Symptoms of an allergic reaction include: • shortness of breath, wheezing, difficulty breathing or a tight feeling in your chest • swelling of the face, lips, tongue or other parts of the body • rash Read the complete document
Page 1 of 40 PRODUCT INFORMATION DOCETAXEL KABI NAME OF MEDICINE Docetaxel DESCRIPTION Chemical structure: (docetaxel anhydrous) CAS number 114977-28-5 DOCETAXEL Docetaxel is: (2_R_,3_S_)-_N_-carboxy-3-phenylisoserine, _N_-_tert_-butyl ester, 13-ester with 5_ß_, 20-epoxy-1, 2 α _,_ 4, 7_ß_, 10_ß_, 13 α -hexahydroxytax-11-en-9-one 4-acetate 2-benzoate. Docetaxel is a white to almost white powder with the empirical formula C 43 H 53 NO 14 and a molecular weight of 807.9. It is highly lipophilic and practically insoluble in water. Single-dose vials of Docetaxel Kabi concentrated injection containing 20, 80 or 160 mg of docetaxel per 1.0, 4.0 or 8.0 mL, respectively, in 50/50 (v/v) polysorbate 80/absolute ethanol. The sterile pyrogen-free viscous solution contains 20 mg/mL docetaxel. PHARMACOLOGY CLASS Docetaxel is an antineoplastic agent which acts by promoting the assembly of tubulin into stable microtubules and inhibits their disassembly which leads to a marked decrease of free tubulin. The binding of docetaxel to microtubules does not alter the number of protofilaments. SITE AND MODE OF ACTION Docetaxel has been shown _in vitro_ to disrupt the microtubular network in cells which is essential for vital mitotic and interphase cellular functions. Page 2 of 40 PHARMACODYNAMICS Preclinical Data Docetaxel was found to be cytotoxic _in vitro_ against various murine and human tumour cell lines and against freshly excised human tumour cells in clonogenic assays. Docetaxel achieves high intracellular concentrations with a long cell residence time. In addition, docetaxel was found to be active on some, but not all, cell lines overexpressing the _p_-glycoprotein which is encoded by the multidrug resistance gene. _In vivo_, docetaxel is schedule independent and has a broad spectrum of experimental antitumour activity against advanced murine and human grafted tumours. Against transplantable murine tumours _ in vivo_, docetaxel was synergistic with vincristine (administered at the same time), etoposide, cyclophosphamide or Read the complete document