Država: Evropska unija
Jezik: angleščina
Source: EMA (European Medicines Agency)
neratinib
Pierre Fabre Medicament
L01EH02
neratinib
Antineoplastic agents
Breast Neoplasms
Nerlynx is indicated for the extended adjuvant treatment of adult patients with early stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who are less than one year from the completion of prior adjuvant trastuzumab based therapy.
Revision: 13
Authorised
2018-08-31
27 B. PACKAGE LEAFLET 28 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT NERLYNX 40 MG FILM-COATED TABLETS neratinib READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Nerlynx is and what it is used for 2. What you need to know before you take Nerlynx 3. How to take Nerlynx 4. Possible side effects 5. How to store Nerlynx 6. Contents of the pack and other information 1. WHAT NERLYNX IS AND WHAT IT IS USED FOR WHAT NERLYNX IS Nerlynx contains the active substance ‘neratinib’. It belongs to a group of medicines called ‘tyrosine kinase inhibitors’ used to block cancer cells and treat breast cancer. WHAT NERLYNX IS USED FOR Nerlynx is used for patients who have early stage breast cancer which: - is hormone receptor positive (HR-positive) and human epidermal growth factor receptor 2- positive (HER2-positive), and - has previously been treated with another medicine called ‘trastuzumab’. 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. ‘Hormone receptors’ are also proteins expressed inside the cells of some specific tissues. Estrogens and progesterone bind to these proteins and regulate cell activity. In HR-positive breast cancer, tumor cell division and growth can be enhanced by estrogens and/or progesterone. Before Nerlynx is used, your cancer mus Preberite celoten dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Nerlynx 40 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains neratinib maleate, equivalent to 40 mg neratinib. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Oval, red film-coated tablet with ‘W104’ debossed on one side. Tablet dimensions are 10.5 mm x 4.3 mm with thickness of 3.1 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATION Nerlynx is indicated for the extended adjuvant treatment of adult patients with early-stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who completed adjuvant trastuzumab-based therapy less than one year ago. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Nerlynx treatment should be initiated and supervised by a physician experienced in the administration of anti-cancer medicinal products. Posology The recommended dose of Nerlynx is 240 mg (six 40 mg tablets) taken orally once daily, continuously for one year. Nerlynx should be taken with food, preferably in the morning. Patients should initiate treatment within 1 year after completion of trastuzumab therapy. _Dose modifications for adverse reactions_ Nerlynx dose modification is recommended based on individual safety and tolerability. Management of some adverse reactions may require dose interruption and/or dose reduction as shown in Table 1, Table 2, Table 3, and Table 4. Nerlynx should be discontinued for patients who: • Fail to recover to Grade 0 to 1 from treatment-related toxicity, • For toxicities that result in a treatment delay > 3 weeks, or • For patients that are unable to tolerate 120 mg daily Additional clinical situations may result in dose adjustments as clinically indicated (e.g. intolerable toxicities, persistent Grade 2 adverse reactions, etc.). 3 TABLE 1: NERLYNX DOSE MODIFICATIONS FOR ADVERSE REACTIONS DOSE LEVEL NERLYNX DOSE Recommended starting dose 240 mg daily First dose reduction 200 mg daily Second do Preberite celoten dokument