Држава: Аустралија
Језик: Енглески
Извор: Department of Health (Therapeutic Goods Administration)
alpelisib, Quantity: 200 mg
Novartis Pharmaceuticals Australia Pty Ltd
Tablet, film coated
Excipient Ingredients: microcrystalline cellulose; mannitol; sodium starch glycollate; hypromellose; magnesium stearate; purified talc; macrogol 4000; iron oxide black; iron oxide red; titanium dioxide
Oral
14, 28
(S4) Prescription Only Medicine
PIQRAY in combination with fulvestrant, is indicated for the treatment of postmenopausal women, and men, with hormone receptor positive, HER2-negative, advanced or metastatic breast cancer with a PIK3CA mutation as detected by a validated test following progression on or after an endocrine-based regimen
Visual Identification: Light red, unscored, ovaloid and curved with bevelled edges film-coated tablet, imprinted with YL7 on one side and NVR on the other side; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2020-03-20
PIQRAY ® P I Q R A Y ® 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. ▼ This medicine is new or being used differently. Please report side effects. See the full CMI for further details. 1. WHY AM I USING PIQRAY? PIQRAY contains the active ingredient Alpelisib. PIQRAY is used with a medicine called fulvestrant to treat certain types of advanced breast cancer in adult women and men. For more information, see Section 1. Why am I using PIQRAY? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE PIQRAY? Do not use if you have ever had an allergic reaction to PIQRAY 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. For more information, see Section 2. What should I know before I use PIQRAY? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with PIQRAY 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 PIQRAY? • The usual dose of PIQRAY is 300 mg (two 150 mg film-coated tablets) taken orally, once daily. You should take PIQRAY immediately after food, at approximately the same time each day. More instructions can be found in Section 4. How do I use PIQRAY? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING PIQRAY? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using PIQRAY. • Have regular blood tests to monitor your condition. THINGS YOU SHOULD NOT DO • Do not stop using this medicine suddenly (unless your doctor tells you to). DRIVING OR USING MACHINES • PIQRAY has minor influence on the ability to drive and use machines. Be cautious when driving or using machines in case you feel tired with taking PIQRAY. DRINKING ALCOHOL • There are no known interactions between Прочитајте комплетан документ
This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at www.tga.gov.au/reporting-problems. AUSTRALIAN PRODUCT INFORMATION - PIQRAY (ALPELISIB) TABLETS 1. NAME OF THE MEDICINE Alpelisib 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE All PIQRAY tablets contain alpelisib. PIQRAY 50 mg tablet Each tablet contains 50 mg of alpelisib. PIQRAY 150 mg tablet Each tablet contains 150 mg of alpelisib. PIQRAY 200 mg tablet Each tablet contains 200 mg of alpelisib. EXCIPIENTS For the list of excipients, see section 6.1 List of Excipients. 3. PHARMACEUTICAL FORM FILM COATED TABLETS PIQRAY 50 mg tablet Light pink, unscored, round and curved with bevelled edges, imprinted with “L7” on one side and “NVR” on the other side. PIQRAY 150 mg tablet Pale red, unscored, ovaloid and curved with bevelled edges, imprinted with “UL7” on one side and “NVR” on the other side. PIQRAY 200 mg tablet Light red, unscored, ovaloid and curved with bevelled edges, imprinted with “YL7” on one side and “NVR” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS PIQRAY in combination with fulvestrant, is indicated for the treatment of postmenopausal women, and men, with hormone receptor positive, HER2-negative, advanced or metastatic breast cancer with a PIK3CA mutation as detected by a validated test following progression on or after an endocrine-based regimen. 4.2 DOSE AND METHOD OF ADMINISTRATION Treatment with PIQRAY should be initiated by a physician experienced in the use of anticancer therapies. ▼ Page 2 of 26 Patients with HR positive, HER2 negative advanced breast cancer should be selected for treatment with PIQRAY, based on the presence of a PIK3CA mutation in tumour or plasma specimens, using a validated test. If a mutation is not detected in a plasma specimen, test tumour tissue if available. The safety and efficacy of alp Прочитајте комплетан документ