Land: Malaysia
Språk: engelska
Källa: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Neratinib Maleate
ZUELLIG PHARMA SDN BHD
Neratinib Maleate
180 Tablets
Excella GmbH & Co.KG
_Consumer Medication Information Leaflet (RiMUP) _ 1 NERLYNX ® FILM-COATED TABLETS _Neratinib (40mg) _ _ _ _ _ WHAT IS IN THIS LEAFLET 1. What Nerlynx is used for 2. How Nerlynx works 3. Before you use Nerlynx 4. How to use Nerlynx 5. While you are using it 6. Side effects 7. Storage and Disposal of Nerlynx 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision This leaflet answers some common questions about Nerlynx Tablets. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Nerlynx against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may want to read it again. 1. WHAT NERLYNX IS USED FOR Nerlynx contains the active substance neratinib. Neratinib belongs to a group of medicines called ‘tyrosine kinase inhibitors’ used to block cancer cells and treat breast cancer. Nerlynx is used for women who have early stage breast cancer which: - is human epidermal growth factor receptor 2-positive (HER2- positive) and - has previously been treated with another medicine called ‘trastuzumab’ - NERLYNX is also used with a medicine called capecitabine to treat adults with HER2-positive breast cancer that has spread to other parts of the body (metastatic) and who have received 2 or more anti-HER2 therapy medicines for metastatic breast cancer. The ‘HER2 receptor’ is a protein found on the surface of cells in the body. It helps control how a healthy breast cell grows. In HER2-positive breast cancer, the cancer cells have a large amount of HER2 receptors on their surface. This results in the cancer cells dividing and growing faster. Before Nerlynx is used, your cancer must have been tested to show it is HER2-positive. You must also have previously been treated with trastuzumab. 2. HOW NERLYNX WORKS Nerlynx Läs hela dokumentet
NERLYNX ® (NERATINIB) FILM-COATED TABLETS 40 MG 1 INDICATIONS AND USAGE 1.1 EXTENDED ADJUVANT TREATMENT OF EARLY-STAGE BREAST CANCER NERLYNX is indicated for the extended adjuvant treatment of women with early-stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who completed adjuvant trastuzumab-based therapy less than one year ago [see _Clinical Studies (13.1)_ ]. 1.2 ADVANCED OR METASTATIC BREAST CANCER NERLYNX in combination with capecitabine is indicated for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti- HER2 based regimens in the metastatic setting [see _Clinical Studies (13.2)_ ]. 2 DOSAGE AND ADMINISTRATION 2.1 PREMEDICATION FOR DIARRHEA When not using dose escalation _[see Dosage and Administration (2.2)],_ administer antidiarrheal prophylaxis during the first 56 days of treatment and initiate with the first dose of NERLYNX _[see Warnings and Precautions (5.1) and _ _Adverse Reactions (6.1)]._ Instruct patients to take loperamide as directed in Table 1. Titrate loperamide to 1-2 bowel movements per day. TABLE 1: LOPERAMIDE PROPHYLAXIS TIME ON NERLYNX LOPERAMIDE DOSE AND FREQUENCY Weeks 1-2 (days 1 - 14) 4 mg three times daily Weeks 3-8 (days 15 - 56) 4 mg twice daily Weeks 9-Discontinuation of NERLYNX 4 mg as needed, not to exceed 16 mg per day; titrate dosing to achieve 1-2 bowel movements per day If diarrhea occurs despite prophylaxis, treat with additional antidiarrheals, fluids and electrolytes as clinically indicated. NERLYNX dose interruptions and dose reductions may also be required to manage diarrhea [ _see Dosage and Administration (2.3)_ ]. 2.2 RECOMMENDED DOSE AND SCHEDULE _EXTENDED ADJUVANT TREATMENT OF EARLY-STAGE BREAST CANCER _ The recommended dose of NERLYNX is 240 mg (six tablets) given orally once daily with food, continuously until disease recurrence or for up to one year. _ADVANCED OR METASTATIC BREAST CANCER _ The recommended dose of NERLYNX is 240 mg (six tablets) given oral Läs hela dokumentet