Страна: Європейський Союз
мова: англійська
Джерело: EMA (European Medicines Agency)
Lorlatinib
Pfizer Europe MA EEIG
L01ED05
lorlatinib
Antineoplastic agents, Protein kinase inhibitors
Carcinoma, Non-Small-Cell Lung
Lorviqua as monotherapy is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)‑positive advanced non‑small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor.Lorviqua as monotherapy is indicated for the treatment of adult patients with ALK‑positive advanced NSCLC whose disease has progressed after:alectinib or ceritinib as the first ALK tyrosine kinase inhibitor (TKI) therapy; orcrizotinib and at least one other ALK TKI.
Revision: 11
Authorised
2019-05-06
34 B. PACKAGE LEAFLET 35 PACKAGE LEAFLET: INFORMATION FOR THE USER LORVIQUA 25 MG FILM-COATED TABLETS LORVIQUA 100 MG FILM-COATED TABLETS lorlatinib 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 Lorviqua is and what it is used for 2. What you need to know before you take Lorviqua 3. How to take Lorviqua 4. Possible side effects 5. How to store Lorviqua 6. Contents of the pack and other information 1. WHAT LORVIQUA IS AND WHAT IT IS USED FOR WHAT LORVIQUA IS Lorviqua contains the active substance lorlatinib, a medicine that is used for treatment of adults with advanced stages of a form of lung cancer called non-small cell lung cancer (NSCLC). Lorviqua belongs to the group of medicines that inhibit an enzyme called anaplastic lymphoma kinase (ALK). Lorviqua is only given to patients who have an alteration in the ALK gene, see HOW LORVIQUA WORKS below. WHAT LORVIQUA IS USED FOR Lorviqua is used to treat adults with a type of lung cancer called non-small cell lung cancer (NSCLC). It is used if your lung cancer: - is ALK-positive – this means your cancer cells have a fault in a gene that makes an enzyme called ALK (anaplastic lymphoma kinase), see HOW LORVIQUA WORKS, below; and - is advanced. Lorviqua can be prescribed to you if: - you have not been previousl Прочитайте повний документ
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 Lorviqua 25 mg film-coated tablets Lorviqua 100 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Lorviqua 25 mg film-coated tablets Each film-coated tablet contains 25 mg of lorlatinib. _Excipient with known effect_ Each film-coated tablet contains 1.58 mg of lactose monohydrate. Lorviqua 100 mg film-coated tablets Each film-coated tablet contains 100 mg of lorlatinib. _Excipient with known effect_ Each film-coated tablet contains 4.20 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Lorviqua 25 mg film-coated tablets Round (8 mm) light pink immediate release film-coated tablet, debossed with “Pfizer” on one side and “25” and “LLN” on the other side. Lorviqua 100 mg film-coated tablets Oval (8.5 × 17 mm) dark pink immediate release film-coated tablet, debossed with “Pfizer” on one side and “LLN 100” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Lorviqua as monotherapy is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor. 3 Lorviqua as monotherapy is indicated for the treatment of adult patients with ALK-positive advanced NSCLC whose disease has progressed after: alectinib or ceritinib as the first ALK tyrosine kinase inhibitor (TKI) therapy; or crizotinib and at least one other ALK TKI. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with lorlatinib should be initiated and supervised by a physician experienced in the use of anticancer medicinal products. Detection of ALK-positive NSCLC is necessary for Прочитайте повний документ