Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
Vandetanib
Sanofi B.V.
L01XE
vandetanib
Antineoplastic and immunomodulating agents
Thyroid Neoplasms
Caprelsa is indicated for the treatment of aggressive and symptomatic medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease.Caprelsa is indicated in adults, children and adolescents aged 5 years and older.For patients in whom re-arranged-during-transfection(RET) mutation is not known or is negative, a possible lower benefit should be taken into account before individual treatment decision.
Revision: 52
Authorised
2012-02-16
31 B. PACKAGE LEAFLET 32 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CAPRELSA 100 MG FILM-COATED TABLETS CAPRELSA 300 MG FILM-COATED TABLETS vandetanib In addition to this leaflet you will be given the Patient Alert Card, which contains important safety information that you need to know before you are given Caprelsa and during treatment with Caprelsa. _ _ _ _ READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet and the patient alert card. You may need to read it again. - It is important that you keep the Alert Card with you during treatment. - 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 Caprelsa is and what it is used for 2. What you need to know before you take Caprelsa 3. How to take Caprelsa 4. Possible side effects 5. How to store Caprelsa 6. Contents of the pack and other information 1. WHAT CAPRELSA IS AND WHAT IT IS USED FOR CAPRELSA IS A TREATMENT FOR ADULTS AND CHILDREN AGED 5 YEARS AND ABOVE WITH: Type of medullary thyroid cancer that is called Rearranged during Transfection (RET) mutant and which cannot be removed by surgery or has spread to other parts of the body. Caprelsa works by slowing down the growth of new blood vessels in tumours (cancers). This cuts off the supply of food and oxygen to the tumour. Caprelsa may also act directly on cancer cells to kill them or slow down their growth. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CAPRELSA DO NOT TAKE CAPRELSA: - if you are allergic to vandetanib or any of the other ingredients of this medicine (listed in Section 6). - if you have a heart problem that you were born with called ‘congenital long QTc syndrom Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Caprelsa 100 mg film-coated tablets Caprelsa 300 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Caprelsa 100 mg tablets Each film-coated tablet contains 100 mg of vandetanib. Caprelsa 300 mg tablets Each film-coated tablet contains 300 mg of vandetanib. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Caprelsa 100 mg tablets The Caprelsa 100 mg tablet is a round, biconvex, white film-coated tablet with ‘Z100’ impressed on one side. Caprelsa 300 mg tablets The Caprelsa 300 mg tablet is an oval-shaped, biconvex, white film-coated tablet with ‘Z300’ impressed on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Caprelsa is indicated for the treatment of aggressive and symptomatic Rearranged during Transfection (RET) mutant medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease. Caprelsa is indicated in adults, children and adolescents aged 5 years and older. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be initiated and supervised by a physician experienced in treatment of MTC and in the use of anticancer medicinal products and experienced in the assessment of electrocardiogram (ECG). Rearranged during transfection (RET) status Since the activity of Caprelsa, based on available data, is considered insufficient in patients with no identified RET mutation, the presence of a RET mutation should be determined by a validated test prior to initiation of treatment with Caprelsa. When establishing RET mutation status, tissue samples should be obtained if possible at the time of initiation of treatment rather than at the time of diagnosis. Posology for MTC in adult patients The recommended dose is 300 mg once a day, taken with or without food at about the same time each day. 3 If a dose is missed, it should be taken as soon as the patient remembers. If it is less than 12 hours to the next dose, the patient should not take the mi Прочетете целия документ