Valsts: Eiropas Savienība
Valoda: angļu
Klimata pārmaiņas: EMA (European Medicines Agency)
cobimetinib hemifumarate
Roche Registration GmbH
L01XE38
cobimetinib
Antineoplastic agents
Melanoma
Cotellic is indicated for use in combination with vemurafenib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.
Revision: 14
Authorised
2015-11-20
31 B. PACKAGE LEAFLET 32 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT COTELLIC 20 MG FILM-COATED TABLETS cobimetinib 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 Cotellic is and what it is used for 2. What you need to know before you take Cotellic 3. How to take Cotellic 4. Possible side effects 5. How to store Cotellic 6. Contents of the pack and other information 1. WHAT COTELLIC IS AND WHAT IT IS USED FOR WHAT COTELLIC IS Cotellic is an anti-cancer medicine that contains the active substance cobimetinib. _ _ WHAT COTELLIC IS USED FOR Cotellic is used to treat adult patients with a type of skin cancer called melanoma, that has spread to other parts of the body or cannot be removed by surgery. • It is used in combination with another anti-cancer medicine called vemurafenib. • It can only be used in patients whose cancer has a change (mutation) in a protein called “BRAF”. Before starting treatment, your doctor will test for this mutation. This change may have led to the development of melanoma. HOW COTELLIC WORKS Cotellic targets a protein called “MEK” that is important in controlling cancer cell growth. When Cotellic is used in combination with vemurafenib (which targets the changed “BRAF” protein), it further slows down or stops the growth of your cancer. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE COTELLIC DO NOT TAKE COTELLIC: • if you are allergic to cobimetinib or any of the other ingredients of this medicine (listed in section 6). If you are not su Izlasiet visu dokumentu
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Cotellic 20 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains cobimetinib hemifumarate equivalent to 20 mg cobimetinib. Excipient with known effect Each film-coated tablet contains 36 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. White, round film-coated tablets of approximately 6.6 mm diameter, with “COB” debossed on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cotellic is indicated for use in combination with vemurafenib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation (see sections 4.4 and 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Cotellic in combination with vemurafenib should only be initiated and supervised by a qualified physician experienced in the use of anticancer medicinal products. Before starting this treatment, patients must have BRAF V600 mutation-positive melanoma tumour status confirmed by a validated test (see sections 4.4 and 5.1). Posology The recommended dose of Cotellic is 60 mg (3 tablets of 20 mg) once daily. Cotellic is taken on a 28 day cycle. Each dose consists of three 20 mg tablets (60 mg) and should be taken once daily for 21 consecutive days (Days 1 to 21-treatment period); followed by a 7-day break (Days 22 to 28-treatment break). Each subsequent Cotellic treatment cycle should start after the 7-day treatment break has elapsed. For information on the posology of vemurafenib, please refer to its SmPC. _ _ _Duration of treatment _ _ _ Treatment with Cotellic should continue until the patient no longer derives benefit or until the development of unacceptable toxicity (see Table 1 below). 3 _Missed doses _ _ _ If a dose is missed, it can be taken up to 12 hours prior to the next dose to maintain the once-daily regimen. _Vomiting _ In case of vomiting after administration of Cotellic, the patien Izlasiet visu dokumentu