Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
oxaliplatin
Sanofi-Aventis Australia Pty Ltd
Oxaliplatin
Registered
Page 1 ELOXATIN ® _Oxaliplatin concentrated solution for injection _ CONSUMER MEDICINE INFORMATION Please read this leaflet before you are given this medicine. WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Eloxatin injection. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of using Eloxatin against the benefits it is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. Keep this leaflet with the medicine. YOU MAY NEED TO READ IT AGAIN. WHAT ELOXATIN IS USED FOR Eloxatin is used to treat cancer of the oesophagus/stomach, large intestine and rectum (colorectal cancer). Eloxatin is used in combination with other anti-cancer drugs; capecitabine, bevacizumab, epirubicin, fluorouracil (FU), and/or folinic acid. The active ingredient in Eloxatin is called oxaliplatin. Cancer cells are normal cells which have changed so that they grow in an uncontrolled way. Oxaliplatin works by interfering with cancer cell growth. Because of the similarities between cancer cells and normal cells, anti cancer drugs often have unwanted effects on the body. Your doctors have decided to treat you with Eloxatin because they believe that the benefit of Eloxatin treatment will be greater than the unwanted effects. Many of the side effects from anti cancer drugs are predictable and can be prevented or lessened. Your doctor and other staff will take all of the precautions needed to reduce the unwanted effects of treatment. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Eloxatin is only available on a prescription from you doctor. BEFORE YOU ARE GIVEN ELOXATIN _WHEN YOU MUST NOT RECEIVE _ _IT _ YOU SHOULD NOT BE GIVEN ELOXATIN IF YOU ARE ALLERGIC TO THE ACTIVE INGREDIENT 'OXALIPLATIN'. If you have had an allergic reaction to oxaliplatin before, you should not receive it agai Read the complete document
eloxatin-ccdsv15-piv7-11sep19 Page 1 of 37 AUSTRALIAN PRODUCT INFORMATION – ELOXATIN (OXALIPLATIN) 1 NAME OF THE MEDICINE Oxaliplatin 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Eloxatin powder for injection is available in the following strengths: • Oxaliplatin 50 mg • Oxaliplatin 100 mg Eloxatin concentrate for injection is available in the following strengths: • Oxaliplatin 50 mg • Oxaliplatin 100 mg • Oxaliplatin 200 mg Oxaliplatin is a white to off-white crystalline powder. It is slightly soluble in water, very slightly soluble in methanol and practically insoluble in ethanol. Eloxatin powder for injection contains oxaliplatin and lactose and the concentrated solution for injection contains oxaliplatin and water for injections. 3 PHARMACEUTICAL FORM Powder for injection: White to off-white freeze-dried powder in a clear glass vial Concentrated solution for injection: A liquid contained in a clear glass vial 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oxaliplatin is indicated for adjuvant treatment of stage III (Duke’s C) colon cancer, in combination with fluoropyrimidine agent. Oxaliplatin in combination with fluorouracil and folinic acid is indicated for the treatment of advanced colorectal cancer. Oxaliplatin in combination with capecitabine, with or without bevacizumab, is indicated for the treatment of patients with metastatic colorectal cancer. Oxaliplatin in combination with epirubicin and either capecitabine or fluorouracil, is indicated for: the treatment of patients with advanced oesophagogastric cancer. eloxatin-ccdsv15-piv7-11sep19 Page 2 of 37 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE In combination with fluorouracil and folinic acid for adjuvant treatment of colon cancer, the recommended dose of oxaliplatin is 85 mg/m2 intravenously repeated every two weeks for 12 cycles (6 months). In combination with capecitabine for adjuvant treatment of colon cancer, the recommended dose of oxaliplatin is 130 mg/m2, administered as an intravenous infusion over 2 hours on day 1 of a thr Read the complete document