Land: Malaysia
Språk: engelska
Källa: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Alpelisib
NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.
Alpelisib
14 Tablets
NOVARTIS PHARMA STEIN AG
TREZILENT ® Film-coated Tablets Alpelisib (50mg, 150mg, 200mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What Trezilent ® is used for 2. How Trezilent ® works 3. Before you use Trezilent ® 4. How to use Trezilent ® 5. While you are using it 6. Side effects 7. Storage and Disposal of Trezilent ® 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT TREZILENT ® IS USED FOR Trezilent ® is a prescription medicine used in combination with the medicine fulvestrant to treat women who have gone through menopause and men: • who have hormone receptor (HR)- positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer or breast cancer that has spread to other parts of the body (metastatic), with an abnormal phosphatidylinositol-3- kinase catalytic subunit alpha (PIK3CA) gene, AND • whose disease has progressed on or after endocrine therapy. Your healthcare provider will test your cancer for an abnormal “PIK3CA” gene to make sure that Trezilent ® is right for you. It is not known if Trezilent ® is safe and effective in children. HOW TREZILENT ® WORKS Trezilent ® works by blocking the effects of enzymes called phosphatidylinositol-3- kinases (PI3K) which signal cancer cells to grow and multiply. By blocking these enzymes, Trezilent ® can reduce cancer cell growth and the ability to make new cancer cells, and can destroy cancer cells. Trezilent ® has to be used together with another medicine called fulvestrant. If you have any questions about how Trezilent ® works or why this medicine has been prescribed for you, ask your doctor, pharmacist or healthcare provider. BEFORE YOU USE TREZILENT ® - When you must not use it Do not take Trezilent ® if you have had a severe allergic reaction to Trezilent ® or are allergic to any of the ingredients in Trezilent ® . See the end of this Patient Information leaflet for a complete list of the ingredients in Trezilent ® . See “Things to be careful of” fo Läs hela dokumentet
FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE TREZILENT is indicated in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen. 2 DOSAGE AND ADMINISTRATION 2.1 PATIENT SELECTION Select patients for the treatment of HR-positive, HER2-negative advanced or metastatic breast cancer with TREZILENT, based on the presence of one or more PIK3CA mutations in tumor tissue or plasma specimens _[see Clinical Studies (14)]_ . If no mutation is detected in a plasma specimen, test tumor tissue. 2.2 DOSAGE AND ADMINISTRATION The recommended dose of TREZILENT is 300 mg (two 150 mg film-coated tablets) taken orally, once daily, with food _[see Clinical Pharmacology (12.3)]_ . Continue treatment until disease progression or unacceptable toxicity occurs _[see Dosage and Administration _ _(2.3)]_ . Patients should take their dose of TREZILENT at approximately the same time each day. Swallow TREZILENT tablets whole (tablets should not be chewed, crushed or split prior to swallowing). No tablet should be ingested if it is broken, cracked, or otherwise not intact. If a dose of TREZILENT is missed, it can be taken with food within 9 hours after the time it is usually taken. After more than 9 hours, skip the dose for that day. The next day, take TREZILENT at the usual time. If the patient vomits after taking the dose, advise the patient not to take an additional dose on that day, and to resume the dosing schedule the next day at the usual time. When given with TREZILENT, the recommended dose of fulvestrant is 500 mg administered on Days 1, 15, and 29, and once monthly thereafter. Refer to the Full Prescribing Information for fulvestrant. 2.3 DOSE MODIFICATIONS FOR ADVERSE REACTIONS The recommended dose modifications for adverse reactions (ARs) are listed in Table 1. TABLE 1: TREZILENT DOSE REDUCTION G Läs hela dokumentet