Negara: Inggris
Bahasa: Inggris
Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)
Cobimetinib hemifumarate
Roche Products Ltd
L01XE38
Cobimetinib hemifumarate
20mg
Tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 08010500
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT COTELLIC 20 MG FILM-COATED TABLETS COBIMETINIB ▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. 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 Baca dokumen lengkapnya
OBJECT 1 COTELLIC 20 MG FILM-COATED TABLETS Summary of Product Characteristics Updated 26-Mar-2018 | Roche Products Limited This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 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 Baca dokumen lengkapnya