Страна: Австралия
Язык: английский
Источник: Department of Health (Therapeutic Goods Administration)
abemaciclib, Quantity: 150 mg
Eli Lilly Australia Pty Ltd
Tablet, film coated
Excipient Ingredients: croscarmellose sodium; microcrystalline cellulose; lactose monohydrate; purified talc; iron oxide yellow; silicon dioxide; polyvinyl alcohol; macrogol 3350; sodium stearylfumarate; titanium dioxide
Oral
14, 56, 42, 70
(S4) Prescription Only Medicine
Early Breast Cancer VERZENIO in combination with endocrine therapy is indicated for the adjuvant treatment of patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, node-positive early breast cancer at high risk of recurrence.,In pre- or peri-menopausal women, endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.,Advanced or Metastatic Breast Cancer VERZENIO is indicated for the treatment of hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or following prior endocrine therapy.,In pre- or peri-menopausal women, the endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.
Visual Identification: Modified oval tablets with "Lilly" debossed on one side and 150 mg on the other side; Container Type: Blister Pack; Container Material: PVC/PE/PCTFE (Aclar)/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Registered
2019-04-08
VERZENIO™ V E R Z E N I O ™ V A 0 5 A p r 2 0 2 2 S u p e r s e d e s : V 0 3 M a r 2 0 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 VERZENIO? VERZENIO contains the active ingredient abemaciclib. VERZENIO is used to treat patients with certain types of breast cancer which have not spread to other parts of the body or spread beyond the original tumour and/or to other organs. For more information, see Section 1. Why am I using VERZENIO? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE VERZENIO? Do not use if you have ever had an allergic reaction to VERZENIO 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 VERZENIO? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with VERZENIO 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 VERZENIO? • Swallow tablet whole with a full glass of water • Do not chew, crush or split the tablets before swallowing. VERZENIO may be taken with or without food. More instructions can be found in Section 4. How do I use VERZENIO? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING VERZENIO? THINGS YOU SHOULD DO • Remind any doctor, dentist, pharmacist or anaesthetist you visit that you are using VERZENIO. • If you become pregnant while taking this medicine, tell your doctor immediately. THINGS YOU SHOULD NOT DO • Do not stop using this medicine or lower the dosage without checking with the doctor. • Do not take grapefruit products while on this therapy as it may in Прочитать полный документ
VA6.0Apr2022 Supersedes VA5.0 MON2April2021 Page 1 of 31 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 PI – VERZENIO™ (ABEMACICLIB) TABLET 1 NAME OF THE MEDICINE Abemaciclib 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Abemaciclib (VERZENIO) 50 mg film-coated tablets Each film-coated tablet contains 50 mg abemaciclib. _Excipients with known effect _ Each film-coated tablet contains 14 mg of lactose (monohydrate). Abemaciclib (VERZENIO) 100 mg film-coated tablets Each film-coated tablet contains 100 mg abemaciclib. _Excipients with known effect _ Each film-coated tablet contains 28 mg of lactose (monohydrate). Abemaciclib (VERZENIO) 150 mg film-coated tablets Each film-coated tablet contains 150 mg abemaciclib. _Excipients with known effect _ Each film-coated tablet contains 42 mg of lactose (monohydrate). For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM VERZENIO 50 mg film-coated tablets Beige, modified oval tablet debossed with “Lilly” on one side and “50” on the other. VERZENIO 100 mg film-coated tablets White, modified oval tablet debossed with “Lilly” on one side and “100” on the other. VERZENIO 150 mg film-coated tablets Yellow, modified oval tablet debossed with “Lilly” on one side and “150” on the other. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Early Breast Cancer VERZENIO in combination with endocrine therapy is indicated for the adjuvant treatment of patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, node-positive early breast cancer at high risk of recurrence. ▼ VA6.0Apr2022 Supersedes VA5.0 MON2April2021 Page 2 of 31 In pre- or peri-menopausal women, endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist. Advanced o Прочитать полный документ