Țară: Uniunea Europeană
Limbă: engleză
Sursă: EMA (European Medicines Agency)
vemurafenib
Roche Registration GmbH
L01EC01
vemurafenib
Antineoplastic agents
Melanoma
Vemurafenib is indicated in monotherapy for the treatment of adult patients with BRAF-V600-mutation-positive unresectable or metastatic melanoma.,
Revision: 24
Authorised
2012-02-17
31 B. PACKAGE LEAFLET 32 PACKAGE LEAFLET: INFORMATION FOR THE USER ZELBORAF 240 MG FILM-COATED TABLETS vemurafenib 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. ● 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. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Zelboraf is and what it is used for 2. What you need to know before you take Zelboraf 3. How to take Zelboraf 4. Possible side effects 5. How to store Zelboraf 6. Contents of the pack and other information 1. WHAT ZELBORAF IS AND WHAT IT IS USED FOR Zelboraf is an anticancer medicine that contains the active substance vemurafenib. It is used to treat adult patients with melanoma that has spread to other parts of the body or cannot be removed by surgery. It can only be used in patients whose cancer has a change (mutation) in the “BRAF” gene. This change may have led to the development of melanoma. Zelboraf targets proteins made from this modified gene and slows down or stops the development of your cancer. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZELBORAF DO NOT TAKE ZELBORAF: ● If you are ALLERGIC to vemurafenib or any of the other ingredients of this medicine (listed in section 6 of this leaflet). Symptoms of allergic reactions may include swelling of the face, lips or tongue, difficulty breathing, rash, or fainting sensation. WARNINGS AND PRECAUTIONS Talk to your doctor before taking Zelboraf. Allergic reactions ● ALLERGIC REACTIONS CAN HAPPEN WHILE TAKING ZELBORAF AND MAY BE SEVERE. Stop taking Zelboraf and get medical help immediately if you have any symptoms of an allergic reaction such as swelling of the face, lips or tongue, difficulty brea Citiți documentul complet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Zelboraf 240 mg film-coated tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 240 mg of vemurafenib (as a co-precipitate of vemurafenib and hypromellose acetate succinate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Pinkish white to orange white, oval, biconvex film-coated tablets of approximately 19 mm, with ‘VEM’ engraved on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Vemurafenib is indicated in monotherapy for the treatment of adult patients with BRAF V600 mutation- positive unresectable or metastatic melanoma (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with vemurafenib should be initiated and supervised by a qualified physician experienced in the use of anticancer medicinal products. Before taking vemurafenib, patients must have BRAF V600 mutation-positive tumour status confirmed by a validated test (see sections 4.4 and 5.1). Posology The recommended dose of vemurafenib is 960 mg (4 tablets of 240 mg) twice daily (equivalent to a total daily dose of 1,920 mg). Vemurafenib may be taken with or without food, but consistent intake of both daily doses on an empty stomach should be avoided (see section 5.2). _Duration of treatment_ Treatment with vemurafenib should continue until disease progression or the development of unacceptable toxicity (see tables 1 and 2 below). _Missed doses _ If a dose is missed, it can be taken up to 4 hours prior to the next dose to maintain the twice daily regimen. Both doses should not be taken at the same time. _Vomiting _ In case of vomiting after vemurafenib administration the patient should not take an additional dose of the medicinal product but the treatment should be continued as usual. 3 _Posology adjustments _ Management of adverse drug reactions or QTc prolongation may require dose reduction, temporary interruption and/or treatment discontinuation (see tables 1 and Citiți documentul complet