Country: ইউরোপীয় ইউনিয়ন
ভাষা: ইংরেজি
সূত্র: EMA (European Medicines Agency)
trastuzumab emtansine
Roche Registration GmbH
L01XC14
trastuzumab emtansine
Antineoplastic agents
Breast Neoplasms
Early Breast Cancer (EBC)Kadcyla, as a single agent, is indicated for the adjuvant treatment of adult patients with HER2-positive early breast cancer who have residual invasive disease, in the breast and/or lymph nodes, after neoadjuvant taxane-based and HER2-targeted therapy.Metastatic Breast Cancer (MBC)Kadcyla, as a single agent, is indicated for the treatment of adult patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either:Received prior therapy for locally advanced or metastatic disease, orDeveloped disease recurrence during or within six months of completing adjuvant therapy.
Revision: 15
Authorised
2013-11-15
41 B. PACKAGE LEAFLET 42 PACKAGE LEAFLET: INFORMATION FOR THE USER KADCYLA 100 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION KADCYLA 160 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION trastuzumab emtansine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START BEING GIVEN 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. • 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 Kadcyla is and what it is used for 2. What you need to know before you are given Kadcyla 3. How you are given Kadcyla 4. Possible side effects 5. How to store Kadcyla 6. Contents of the pack and other information 1. WHAT KADCYLA IS AND WHAT IT IS USED FOR WHAT KADCYLA IS Kadcyla contains the active substance trastuzumab emtansine, which is made up of two parts that are linked together: • trastuzumab - a monoclonal antibody that binds selectively to an antigen (a target protein) called human epidermal growth factor receptor 2 (HER2). HER2 is found in large amounts on the surface of some cancer cells where it stimulates their growth. When trastuzumab binds to HER2 it can stop the cancer cells growth and cause them to die. • DM1 – an anti-cancer substance that becomes active once Kadcyla enters the cancer cell. WHAT KADCYLA IS USED FOR Kadcyla is used to treat breast cancer in adults when: • the cancer cells have many HER2 proteins on them - your doctor will test your cancer cells for this. • you have already received the medicine trastuzumab and a medicine known as a taxane. • the cancer has spread to areas near the breast or to other parts of your body (metastasized) • the cancer has not spread to other parts of the body and treatment is going to be given after surgery (treatment after surgery is called adjuvant therapy). 2. WHAT YOU NEED TO KNOW সম্পূর্ণ নথি পড়ুন
1 _ _ ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Kadcyla 100 mg powder for concentrate for solution for infusion. Kadcyla 160 mg powder for concentrate for solution for infusion. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Kadcyla 100 mg powder for concentrate for solution for infusion One vial of powder for concentrate for solution for infusion contains 100 mg of trastuzumab emtansine. After reconstitution one vial of 5 mL solution contains 20 mg/mL of trastuzumab emtansine (see section 6.6). Kadcyla 160 mg powder for concentrate for solution for infusion One vial of powder for concentrate for solution for infusion contains 160 mg of trastuzumab emtansine. After reconstitution one vial of 8 mL solution contains 20 mg/mL of trastuzumab emtansine (see section 6.6). Trastuzumab emtansine is an antibody-drug conjugate that contains trastuzumab, a humanised IgG1 monoclonal antibody produced by mammalian (Chinese hamster ovary) cell suspension culture, covalently linked to DM1, a microtubule inhibitor, via the stable thioether linker MCC (4-[N-maleimidomethyl] cyclohexane-1-carboxylate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for concentrate for solution for infusion. White to off-white lyophilised powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Early Breast Cancer (EBC) Kadcyla, as a single agent, is indicated for the adjuvant treatment of adult patients with HER2-positive early breast cancer who have residual invasive disease, in the breast and/or lymph nodes, after neoadjuvant taxane-based and HER2-targeted therapy. _ _ Metastatic Breast Cancer (MBC) Kadcyla, as a single agent, is indicated for the treatment of adult patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either: • Received prior therapy for locally advanced or metastatic disease, or • Developed disease recurrence during or with সম্পূর্ণ নথি পড়ুন