Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
osimertinib mesilate
AstraZeneca AB
L01XE
osimertinib
Other antineoplastic agents, Protein kinase inhibitors
Carcinoma, Non-Small-Cell Lung
TAGRISSO as monotherapy is indicated for:- the adjuvant treatment after complete tumour resection in adult patients with stage IB-IIIA non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations- the first-line treatment of adult patients NSCLC with activating EGFR mutations.- the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC.TAGRISSO as monotherapy is indicated for:- the adjuvant treatment after complete tumour resection in adult patients with stage IB-IIIA non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations.- the first-line treatment of adult patients with locally advanced or metastatic NSCLC with activating EGFR mutations.- the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC.
Revision: 19
Authorised
2016-02-01
45 B. PACKAGE LEAFLET 46 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT TAGRISSO 40 MG FILM-COATED TABLETS TAGRISSO 80 MG FILM-COATED TABLETS osimertinib 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 TAGRISSO is and what it is used for 2. What you need to know before you take TAGRISSO 3. How to take TAGRISSO 4. Possible side effects 5. How to store TAGRISSO 6. Contents of the pack and other information 1. WHAT TAGRISSO IS AND WHAT IT IS USED FOR TAGRISSO contains the active substance osimertinib, which belongs to a group of medicines called protein kinase inhibitors which are used to treat cancer. TAGRISSO 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) your cancer is likely to respond to treatment with TAGRISSO. TAGRISSO can be prescribed for you: after complete removal of your cancer as a post-surgical (adjuvant) treatment or as the first medicine you receive for your cancer which has spread to other parts of the body or in certain circumstances if you have been treated for your cancer before with other protein kinase inhibitor medicines. HOW TAGRISSO WORKS TAGRISSO works by blocking EGFR and may help to slow or stop your lung cancer from growing. It may also help to reduce the size of the tumour and prevent the tumour from coming back after removal by surgery. If you are receiving TAGRISSO Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT TAGRISSO 40 mg film-coated tablets TAGRISSO 80 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION TAGRISSO 40 mg tablets Each tablet contains 40 mg osimertinib (as mesylate). TAGRISSO 80 mg tablets Each tablet contains 80 mg osimertinib (as mesylate). Excipient with known effect _TAGRISSO 40 mg tablets_ Each tablet contains 0.3 mg sodium. _TAGRISSO 80 mg tablets_ Each tablet contains 0.6 mg sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). TAGRISSO 40 mg tablets Beige, 9 mm, round, biconvex tablet, debossed with “AZ” and “40” on one side and plain on the reverse. TAGRISSO 80 mg tablets Beige, 7.25 x 14.5 mm, oval, biconvex tablet, debossed with “AZ” and “80” on one side and plain on the reverse. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS TAGRISSO as monotherapy is indicated for: the adjuvant treatment after complete tumour resection in adult patients with stage IB-IIIA non- small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations (see section 5.1). the first-line treatment of adult patients with locally advanced or metastatic NSCLC with activating EGFR mutations. 3 the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with TAGRISSO should be initiated by a physician experienced in the use of anticancer therapies. When considering the use of TAGRISSO, EGFR mutation status (in tumour specimens for adjuvant treatment and tumour or plasma specimens for locally advanced or metastatic setting) should be determined using a validated test method (see section 4.4). Posology The recommended dose is 80 mg osimertinib once a day. Patients in the adjuvant setting should receive treatment until disease recurrence or unacceptable toxicity. Treatme Прочетете целия документ