País: União Europeia
Língua: inglês
Origem: EMA (European Medicines Agency)
dacomitinib monohydrate
Pfizer Europe MA EEIG
L01EB07
dacomitinib
Antineoplastic agents
Carcinoma, Non-Small-Cell Lung
Vizimpro, as monotherapy, is indicated for the first-line treatment of adult patients with locally advanced or metastatic non small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) activating mutations.
Revision: 2
Authorised
2019-04-02
31 B. PACKAGE LEAFLET 32 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT VIZIMPRO 15 MG FILM-COATED TABLETS VIZIMPRO 30 MG FILM-COATED TABLETS VIZIMPRO 45 MG FILM-COATED TABLETS dacomitinib 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 Vizimpro is and what it is used for 2. What you need to know before you take Vizimpro 3. How to take Vizimpro 4. Possible side effects 5. How to store Vizimpro 6. Contents of the pack and other information 1. WHAT VIZIMPRO IS AND WHAT IT IS USED FOR Vizimpro contains the active substance dacomitinib, which belongs to a group of medicines called protein tyrosine kinase inhibitors which are used to treat cancer. Vizimpro is used to treat adults with a type of lung cancer called ‘non-small cell lung cancer’. If a test has shown that your cancer has certain changes (mutations) in a gene called ‘EGFR’ (epidermal growth factor receptor) and has spread to your other lung or other organs, your cancer is likely to respond to treatment with Vizimpro. Vizimpro can be used as your first treatment once your lung cancer has spread to your other lung or other organs. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VIZIMPRO DO NOT TAKE VIZIMPRO • if you are allergic to dacomitinib or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before taking Vizimpro: • if you ever had any other lung problems. Some lung problems may get worse during treatment with Vizimpro, as Vizimpro may Leia o documento completo
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Vizimpro 15 mg film-coated tablets Vizimpro 30 mg film-coated tablets Vizimpro 45 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Vizimpro 15 mg film-coated tablets Each film-coated tablet contains dacomitinib monohydrate equivalent to 15 mg dacomitinib. _Excipients with known effect _ Each film-coated tablet contains 40 mg of lactose monohydrate. Vizimpro 30 mg film-coated tablets Each film-coated tablet contains dacomitinib monohydrate equivalent to 30 mg dacomitinib. _Excipients with known effect _ Each film-coated tablet contains 81 mg of lactose monohydrate. Vizimpro 45 mg film-coated tablets Each film-coated tablet contains dacomitinib monohydrate equivalent to 45 mg dacomitinib. _Excipients with known effect _ Each film-coated tablet contains 121 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Vizimpro 15 mg film-coated tablets Blue film-coated, 6.35 mm, round biconvex tablet, debossed with “Pfizer” on one side and “DCB15” on the other. Vizimpro 30 mg film-coated tablets Blue film-coated, 7.5 mm, round biconvex tablet, debossed with “Pfizer” on one side and “DCB30” on the other. Vizimpro 45 mg film-coated tablets Blue film-coated, 9.0 mm, round biconvex tablet, debossed with “Pfizer” on one side and “DCB45” on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Vizimpro, as monotherapy, is indicated for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)-activating mutations. 3 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Vizimpro should be initiated and supervised by a physician experienced in the use of anticancer medicinal products. EGFR mutation status should be established prior to initiation of dacomitinib therapy (see section 4.4). Posology The recommended dose of Vizimpr Leia o documento completo