Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
cabazitaxel acetone solvate, Quantity: 64.17 mg
Sanofi-Aventis Australia Pty Ltd
cabazitaxel acetone solvate
Diluent, not applicable
Excipient Ingredients: water for injections; ethanol
Intravenous
1 drug concentrate vial and 1 diluent vial
(S4) Prescription Only Medicine
Jevtana in combination with prednisone or prednisolone is indicated for the treatment of patients with metastatic castration resistant prostate cancer previously treated with a docetaxel containing regimen.
Visual Identification: Clear, colourless solution; Container Type: Multiple containers; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
2011-12-08
JEVTANA ® J e v t a n a ® CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING JEVTANA? Jevtana contains the active ingredient cabazitaxel. Jevtana is used to treat prostate cancer that has progressed after having had other chemotherapy. For more information, see Section 1. Why am I using Jevtana? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE JEVTANA? Do not use if you have ever had an allergic reaction to cabazitaxel or any of the ingredients listed at the end of the CMI. Do not use if the number of your white blood cells is too low, you have a liver disease or if you have recently received or are about to receive a vaccine against yellow fever. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR IF YOUR PARTNER IS PREGNANT, PLANS TO BECOME PREGNANT OR BREASTFEED. For more information, see Section 2. What should I know before I use Jevtana? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Jevtana and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW IS JEVTANA GIVEN? • Jevtana will be given by infusion into one of your veins (intravenous use). The infusion will last approximately 1 hour during which you will be in the hospital. • You usually receive your infusion once every 3 weeks. More instructions can be found in Section 4.How is Jevtana given? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING JEVTANA? THINGS YOU SHOULD DO • Remind any doctor, dentist, pharmacist or nurse you visit that you are using Jevtana. • Use a condom during sex if your partner is or could become pregnant. • Call your doctor immediately if your partner becomes pregnant while you are being given this medicine THINGS YOU SHOULD NOT DO • Do not stop using this medicine unless your doctor tells you to DRIVING OR USING MACHINES • Read the complete document
jevtana-ccdsv10-piv11-10nov20 Page 1 of 26 AUSTRALIAN PRODUCT INFORMATION – JEVTANA ® (CABAZITAXEL) 1 NAME OF THE MEDICINE Cabazitaxel 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The concentrated solution for injection contains 60 mg cabazitaxel in 1.5 mL polysorbate 80. Diluent contains 13% w/w ethanol in 4.5 mL water for injections. EXCIPIENTS OF KNOWN EFFECT: Diluent contains 13% w/w ethanol. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM The concentrated solution for injection is a clear oily yellow to brownish yellow solution. The diluent is a clear, colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Jevtana in combination with prednisone or prednisolone is indicated for the treatment of patients with metastatic castration resistant prostate cancer previously treated with a docetaxel containing regimen. 4.2 DOSE AND METHOD OF ADMINISTRATION The use of Jevtana should be confined to units specialised in the administration of cytotoxics and it should only be administered under the supervision of a physician experienced in the use of anticancer chemotherapy. PREMEDICATION Premedicate at least 30 minutes prior to each administration of Jevtana with the following intravenous medications to reduce the risk and severity of a hypersensitivity reaction: jevtana-ccdsv10-piv11-10nov20 Page 2 of 26 antihistamine (equivalent to dexchlorpheniramine 5 mg or diphenhydramine 25 mg or equivalent), corticosteroid (dexamethasone 8 mg or equivalent) and with H 2 antagonist (ranitidine or equivalent). Antiemetic prophylaxis is recommended and can be given orally or intravenously as needed (see Section 4.4 Special warnings and precautions for use). RECOMMENDED DOSAGE The recommended dose of Jevtana is 20 mg/m2 administered as a 1-hour intravenous infusion every 3 weeks in combination with oral prednisone (or prednisolone) 10 mg administered daily throughout Jevtana treatment. A dose of 25 mg/m 2 can be used in select patients at the discretion of the treating health Read the complete document