Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
ceritinib
Novartis Europharm Limited
L01XE
ceritinib
Antineoplastic agents
Carcinoma, Non-Small-Cell Lung
Zykadia is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK) positive advanced non small cell lung cancer (NSCLC) previously treated with crizotinib.
Revision: 18
Authorised
2015-05-06
71 B. PACKAGE LEAFLET 72 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ZYKADIA 150 MG HARD CAPSULES ceritinib 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 or pharmacist. - 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Zykadia is and what it is used for 2. What you need to know before you take Zykadia 3. How to take Zykadia 4. Possible side effects 5. How to store Zykadia 6. Contents of the pack and other information 1. WHAT ZYKADIA IS AND WHAT IT IS USED FOR WHAT ZYKADIA IS Zykadia is a cancer medicine that contains the active substance ceritinib. It is used to treat adults with advanced stages of a form of lung cancer called non-small cell lung cancer (NSCLC). Zykadia is only given to patients whose disease is due to a defect in a gene called ALK (anaplastic lymphoma kinase). HOW ZYKADIA WORKS In patients with ALK defects, an abnormal protein is produced that stimulates the growth of the cancer cells. Zykadia blocks the action of this abnormal protein and thus slows down the growth and spread of NSCLC. If you have any questions about how Zykadia works or why this medicine has been prescribed for you, ask your doctor or pharmacist. 73 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZYKADIA DO NOT TAKE ZYKADIA − if you are allergic to ceritinib or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Zykadia: − if you have problems with your liver. − if you have problems with your lungs or problems breathing. − if you have problems with your heart, including reduced he Læs hele dokumentet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Zykadia 150 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 150 mg ceritinib. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule. Capsule with white opaque body and blue opaque cap, size 00 (approximate length: 23.3 mm), with “LDK 150MG” imprinted on the cap and “NVR” on the body, containing white to almost white powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Zykadia 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). Zykadia as monotherapy is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with ceritinib should be initiated and supervised by a physician experienced in the use of anti-cancer medicinal products. ALK testing An accurate and validated ALK assay is necessary for the selection of ALK-positive NSCLC patients (see section 5.1). ALK-positive NSCLC status should be established prior to initiation of ceritinib therapy. Assessment for ALK-positive NSCLC should be performed by laboratories with demonstrated proficiency in the specific technology being utilised. 3 Posology The recommended dose of ceritinib is 450 mg taken orally once daily with food at the same time each day. The maximum recommended dose with food is 450 mg taken orally once daily. Treatment should continue as long as clinical benefit is observed. If a dose is missed, the patient should make up that dose, unless the next dose is due within 12 hours. If vomiting occurs during the course of treatment, the patient should not take an additional dose, but should continue with the next scheduled dose. Ceritinib should be discontinued in patients unable to tolerate 150 mg daily taken with f Læs hele dokumentet