Quốc gia: Liên Minh Châu Âu
Ngôn ngữ: Tiếng Anh
Nguồn: EMA (European Medicines Agency)
talazoparib
Pfizer Europe MA EEIG
L01XK04
talazoparib
Antineoplastic agents
Breast Neoplasms
Talzenna is indicated as monotherapy for the treatment of adult patients with germline BRCA1/2 mutations, who have HER2-negative locally advanced or metastatic breast cancer. Patients should have been previously treated with an anthracycline and/or a taxane in the (neo)adjuvant, locally advanced or metastatic setting unless patients were not suitable for these treatments. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine-based therapy, or be considered unsuitable for endocrine-based therapy.
Revision: 6
Authorised
2019-06-20
49 B. PACKAGE LEAFLET 50 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT TALZENNA 0.1 MG HARD CAPSULES TALZENNA 0.25 MG HARD CAPSULES TALZENNA 1 MG HARD CAPSULES talazoparib This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. 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, pharmacist or nurse. - 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Talzenna is and what it is used for 2. What you need to know before you take Talzenna 3. How to take Talzenna 4. Possible side effects 5. How to store Talzenna 6. Contents of the pack and other information 1. WHAT TALZENNA IS AND WHAT IT IS USED FOR WHAT TALZENNA IS AND HOW IT WORKS Talzenna contains the active substance talazoparib. It is a type of anticancer medicine known as a ‘PARP (poly-ADP ribose polymerase) inhibitor’. Talzenna works by blocking PARP, which is an enzyme that repairs damaged DNA in certain cancer cells. As a result, the cancer cells can no longer repair themselves and they die. WHAT TALZENNA IS USED FOR Talzenna is a medicine used - alone to treat adults with breast cancer of a type known as HER2-negative breast cancer who have an abnormal inherited BRCA gene. Your healthcare provider will perform a test to make sure that Talzenna is right for you. - in combination with a medicine called enzalutamide, to treat adults with prostate cancer who no longer respond to a hormone therapy or surgical treatment to lower testos Đọc toàn bộ tài liệu
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Talzenna 0.1 mg hard capsules Talzenna 0.25 mg hard capsules Talzenna 1 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Talzenna 0.1 mg hard capsules Each hard capsule contains talazoparib tosylate equivalent to 0.1 mg talazoparib. Talzenna 0.25 mg hard capsules Each hard capsule contains talazoparib tosylate equivalent to 0.25 mg talazoparib. Talzenna 1 mg hard capsules Each hard capsule contains talazoparib tosylate equivalent to 1 mg talazoparib. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule (capsule). Talzenna 0.1 mg hard capsules Opaque, approximately 14 mm × 5 mm hard capsule with a white cap (printed with “Pfizer” in black) and a white body (printed with “TLZ 0.1” in black). Talzenna 0.25 mg hard capsules Opaque, approximately 14 mm × 5 mm hard capsule with an ivory cap (printed with “Pfizer” in black) and a white body (printed with “TLZ 0.25” in black). Talzenna 1 mg hard capsules Opaque, approximately 14 mm × 5 mm hard capsule with a light red cap (printed with “Pfizer” in black) and a white body (printed with “TLZ 1” in black). 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Breast cancer Talzenna is indicated as monotherapy for the treatment of adult patients with germline BRCA1/2-mutations, who have HER2-negative locally advanced or metastatic breast cancer. Patients 3 should have been previously treated with an anthracycline and/or a taxane in the (neo)adjuvant, locally advanced or metastatic setting unless patients were not suitable for these treatments (see section 5.1). Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine-based thera Đọc toàn bộ tài liệu