País: Malàisia
Idioma: anglès
Font: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Abemaciclib
ZUELLIG PHARMA SDN BHD
Abemaciclib
14 Tablets
LILLY DEL CARIBE, INC
YULAREB FILM-COATED TABLETS Abemaciclib (50 mg, 100 mg and 150 mg) 1 Consumer Medication Information Leaflet (RiMUP) What is in this leaflet 1. What Yulareb is used for 2. How Yulareb works 3. Before you use Yulareb 4. How to use Yulareb 5. While you are using Yulareb 6. Side effects 7. Storage and Disposal of Yulareb 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision What Yulareb is used for Yulareb is a prescription medicine used: - in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) to treat adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)- negative, node-positive, early breast cancer with a high risk of coming back as determined by your doctor. - in combination with an aromatase inhibitor as the first endocrine-based therapy to treat adult patientswomen who have gone through menopause (postmenopausal),, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has worsened or that has spread to other parts of the body (metastatic). - in combination with fulvestrant to treat women adult with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)- negative breast cancer that has worsened or that has spread to other parts of the body (metastatic) and whose disease has progressed after endocrine therapy. When Yulareb is used in combination with fulvestrant, tamoxifen, or an aromatase inhibitor, also read the Patient Information for the prescribed product. Ask your doctor or pharmacist if you are not sure. How Yulareb works Yulareb contains the active substance abemaciclib. It belongs to a group of medicines called cyclin-dependent kinases 4 and 6 (CDK4 and CDK6) inhibitors. A kinase is a type of protein in the body that helps control cell division. Yularebo works by interfering with the kinase and stopping cancer cells from dividing and growing. Before you use Yulareb - When you must not use it Do not take Yulareb: - if you are Llegiu el document complet
Yulareb PI_USPI Mar2023_EUSPC-eBC June 2023_10Aug2023 Page 1 of 28 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use YULAREB safely and effectively. See full prescribing information for YULAREB. YULAREB (abemaciclib) tablets, for oral use ---------------------------- INDICATIONS AND USAGE --------------------------- YULAREB ® is a kinase inhibitor indicated: • in combination with endocrine therapy is indicated for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive early breast cancer at high risk of recurrence (1.1, 2.1, 14.1). In pre- or perimenopausal women, aromatase inhibitor endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist • in combination with an aromatase inhibitor as initial endocrine- based therapy for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. (1.2) • in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy. (1.2) ------------------------DOSAGE AND ADMINISTRATION----------------------- YULAREB tablets are taken orally with or without food. (2.1) • Recommended starting dose in combination with fulvestrant, tamoxifen, or an aromatase inhibitor: 150 mg twice daily. (2.1) • Dosing interruption and/or dose reductions may be required based on individual safety and tolerability. (2.2) ----------------------DOSAGE FORMS AND STRENGTHS--------------------- Tablets: 50 mg, 100 mg, and 150 mg. (3) ------------------------------- CONTRAINDICATIONS ------------------------------ Hypersensitivity to the active substance or to any of the excipients listed. (11) ------------------------ WARNINGS AND PR Llegiu el document complet