Nchi: Umoja wa Ulaya
Lugha: Kiingereza
Chanzo: EMA (European Medicines Agency)
Encorafenib
Pierre Fabre Medicament
L01EC03
encorafenib
Antineoplastic agents
Melanoma; Colorectal Neoplasms
Encorafenib is indicated:in combination with binimetinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutationin combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, who have received prior systemic therapy
Revision: 11
Authorised
2018-09-19
45 B. PACKAGE LEAFLET 46 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT BRAFTOVI 50 MG HARD CAPSULES BRAFTOVI 75 MG HARD CAPSULES encorafenib 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 Braftovi is and what it is used for 2. What you need to know before you take Braftovi 3. How to take Braftovi 4. Possible side effects 5. How to store Braftovi 6. Contents of the pack and other information 1. WHAT BRAFTOVI IS AND WHAT IT IS USED FOR Braftovi is an anti-cancer medicine that contains the active substance encorafenib. Changes (mutations) in the BRAF gene can produce proteins that cause the cancer to grow. Braftovi targets proteins made from this changed BRAF gene. It is used in combination with another medicine containing binimetinib to treat adult patients with a type of skin cancer called melanoma when it has - a particular change (mutation) in a gene responsible for producing a protein called BRAF, and - spread to other parts of the body, or cannot be removed by surgery When Braftovi is used in combination with binimetinib, which targets another protein that stimulates cancer cell growth, the combination slows down or stops the growth of your cancer. Braftovi is also used in combination with another medicine cetuximab, to treat adult patients with a type of large intestine cancer when it has - a particular change (mutation) in a gene responsible for producing a protein called BRAF, and - spread to other parts of the body of patients who have been previously treated with other anti Soma hati kamili
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Braftovi 50 mg hard capsules Braftovi 75 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Braftovi 50 mg hard capsules Each hard capsule contains 50 mg of encorafenib. Braftovi 75 mg hard capsules Each hard capsule contains 75 mg of encorafenib. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule (capsule). Braftovi 50 mg hard capsules Orange opaque cap and flesh opaque body, printed with a stylised “A” on the cap and “LGX 50mg” on the body. The length of the capsule is approximately 22 mm. Braftovi 75 mg hard capsules Flesh coloured opaque cap and white opaque body, printed with a stylised “A” on the cap and “LGX 75mg” on the body. The length of the capsule is approximately 23 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Encorafenib is indicated: - in combination with binimetinib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation (see sections 4.4 and 5.1). - in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, who have received prior systemic therapy (see sections 4.4 and 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Encorafenib treatment should be initiated and supervised under the responsibility of a physician experienced in the use of anticancer medicinal products. Posology _Melanoma _ The recommended dose of encorafenib is 450 mg (six 75 mg capsules) once daily, when used in combination with binimetinib. 3 _Colorectal cancer _ The recommended dose of encorafenib is 300 mg (four 75 mg capsules) once daily, when used in combination with cetuximab. _Dose modification _ _ _ _Melanoma _ The management of adverse reactions may require dose reduction, temporary interruption or treatment discontinuation of encorafenib (see Tables 1, 3 and 4). For information on the posology and recommended dose modifications of binimetinib, see sec Soma hati kamili