País: Austràlia
Idioma: anglès
Font: Department of Health (Therapeutic Goods Administration)
enzalutamide, Quantity: 40 mg
Astellas Pharma Australia Pty Ltd
enzalutamide
Capsule, soft
Excipient Ingredients: Gelatin; purified water; caprylocaproyl macrogolglycerides; butylated hydroxyanisole; butylated hydroxytoluene; titanium dioxide; sorbitol; glycerol; propylene glycol; ethyl acetate; ethanol; isopropyl alcohol; strong ammonia solution; iron oxide black; macrogol 400; polyvinyl acetate phthalate
Oral
112
(S4) Prescription Only Medicine
XTANDI is indicated for:,? the treatment of patients with metastatic hormone-sensitive prostate cancer.,? the treatment of patients with non-metastatic castration-resistant prostate cancer (see PROSPER, section 5.1 Clinical trials).,? the treatment of patients with metastatic castration resistant prostate cancer following failure of androgen deprivation therapy in whom chemotherapy is not yet indicated.,? the treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel.
Visual Identification: XTANDI 40 mg capsules are supplied as white to off-white oblong soft gelatin capsules imprinted with ENZ in black ink on one side.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2014-07-01
XTANDI ® X T A N D I ® 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 XTANDI? XTANDI contains the active ingredient enzalutamide. XTANDI is used to treat adult men with prostate cancer that no longer responds to hormone therapy or surgical treatment to lower testosterone, or has spread to other parts of the body and is considered "hormone sensitive". For more information, see Section 1. Why am I using XTANDI? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE XTANDI? Do not use if you have ever had an allergic reaction to XTANDI or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. XTANDI IS NOT FOR USE IN WOMEN. For more information, see Section 2. What should I know before I use XTANDI? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with XTANDI 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 DO I USE XTANDI? • The usual dose is four 40 mg capsules taken at the same time once a day. Your doctor may reduce your dose depending on your medical conditions. More instructions can be found in Section 4. How do I use XTANDI? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING XTANDI? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using XTANDI. • THINGS YOU SHOULD NOT DO • Do not take XTANDI to treat any other complaints unless your doctor tells you to. • Do not give your medicine to anyone else, even if they have the same condition as you. • Do not stop taking your medicine or alter the dosage without checking with your doctor. DRIVING OR USING MACHINES • Do not drive or operate machinery until you know how XTANDI affects you. • XTANDI may have a mode Llegiu el document complet
1 AUSTRALIAN PRODUCT INFORMATION XTANDI ® (ENZALUTAMIDE) SOFT CAPSULES 1 NAME OF THE MEDICINE Enzalutamide 2 QUALITATIVE AND QUANTITATIVE COMPOSITION XTANDI is provided as liquid-filled soft gelatin capsules for oral administration. Each soft capsule contains 40 mg of enzalutamide as a solution in caprylocaproyl macrogolglycerides. Excipient(s) with known effect Each soft capsule contains 57.8 mg of sorbitol. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Capsule, soft Supplied as white to off-white oblong soft gelatin capsules imprinted with “ENZ” in black ink on one side. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS XTANDI is indicated for: • the treatment of patients with metastatic hormone-sensitive prostate cancer. • the treatment of patients with non-metastatic castration-resistant prostate cancer (see PROSPER, section 5.1 Clinical trials). • the treatment of patients with metastatic castration resistant prostate cancer following failure of androgen deprivation therapy in whom chemotherapy is not yet indicated. • the treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel. 4.2 D OSE AND METHOD OF ADMINISTRATION Dosage The recommended dose of XTANDI is 160 mg (four 40 mg capsules) as a single oral daily dose. XTANDI can be taken with or without food. XTANDI should be taken at the same time each day. Medical castration with a luteinising hormone-releasing hormone (LHRH) analogue should be continued during treatment of patients not surgically castrated. 2 If a patient misses taking XTANDI at the usual time, the prescribed dose should be taken as close as possible to the usual time. If a patient misses a dose for a whole day, treatment should be resumed the following day with the daily dose. If a patient experiences a ≥ Grade 3 toxicity or an intolerable adverse reaction, withhold dosing for one week or until symptoms improve to ≤ Grade 2, then resume at the same or a reduced dose (120 m Llegiu el document complet