Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
alectinib hydrochloride
Roche Registration GmbH
L01ED03
alectinib
Antineoplastic agents
Carcinoma, Non-Small-Cell Lung
Alecensa as monotherapy is indicated for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).Alecensa as monotherapy is indicated for the treatment of adult patients with ALK‑positive advanced NSCLC previously treated with crizotinib.
Revision: 14
Authorised
2017-02-16
36 B. PACKAGE LEAFLET 37 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ALECENSA 150 MG HARD CAPSULES alectinib 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 Alecensa is and what it is used for 2. What you need to know before you take Alecensa 3. How to take Alecensa 4. Possible side effects 5. How to store Alecensa 6. Contents of the pack and other information 1. WHAT ALECENSA IS AND WHAT IT IS USED FOR WHAT ALECENSA IS Alecensa is a cancer medicine that contains the active substance alectinib. WHAT ALECENSA IS USED FOR Alecensa 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 Alecensa works’, below ● and is advanced. Alecensa can be prescribed to you as first treatment of your lung cancer, or if you have been previously treated with a medicine containing ‘crizotinib’. HOW ALECENSA WORKS Alecensa blocks the action of an enzyme called ‘ALK tyrosine kinase’. Abnormal forms of this enzyme (due to fault in the gene that makes it) help encourage cancer cell growth. Alecensa may slow down or stop the growth of your cancer. It may also help to shrink your cancer. If you have any questions about how Alecensa works or why this medicine has been prescribed for you, ask your doctor, pharmacist or nurse. 38 2. WHAT YOU NEED TO Lesen Sie das vollständige Dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Alecensa 150 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains alectinib hydrochloride equivalent to 150 mg alectinib. Excipients with known effect Each hard capsule contains 33.7 mg lactose (as monohydrate) and 6 mg sodium (as sodium laurilsulfate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule. White hard capsule of 19.2 mm length, with “ALE” printed in black ink on the cap and “150 mg” printed in black ink on the body. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Alecensa as monotherapy is indicated for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). Alecensa as monotherapy is indicated for the treatment of adult patients with ALK-positive advanced NSCLC previously treated with crizotinib. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Alecensa should be initiated and supervised by a physician experienced in the use of anticancer medicinal products. A validated ALK assay is necessary for the selection of ALK-positive NSCLC patients. ALK-positive NSCLC status should be established prior to initiation of Alecensa therapy. Posology The recommended dose of Alecensa is 600 mg (four 150 mg capsules) taken twice daily with food (total daily dose of 1200 mg). Patients with underlying severe hepatic impairment (Child-Pugh C) should receive a starting dose of 450 mg taken twice daily with food (total daily dose of 900 mg). _Duration of treatment _ Treatment with Alecensa should be continued until disease progression or unacceptable toxicity. _Delayed or missed doses _ If a planned dose of Alecensa is missed, patients can make up that dose unless the next dose is due within 6 hours. Patients should not take two doses at the same time to make up for a missed dose. If vomiting occurs after taking a dose of Alecensa, patients should take the next dose at the Lesen Sie das vollständige Dokument