البلد: سنغافورة
اللغة: الإنجليزية
المصدر: HSA (Health Sciences Authority)
Encorafenib
PIERRE FABRE SINGAPORE PTE. LTD.
L01EC03
CAPSULE
Encorafenib 75mg
ORAL
Prescription Only
Catalent Pharma Solutions LLC
ACTIVE
2023-07-19
BRAFTOVI – PI January 2024 Page 1 sur 46 ▼ This therapeutic product is subject to additional monitoring in Singapore. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at HSA | Healthcare professionals' guide to adverse events reporting. PRODUCT INFORMATION BRAFTOVI ® (encorafenib) capsules 1. NAME OF THE MEDICINE Encorafenib 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each BRAFTOVI 50 mg hard capsule contains encorafenib 50 mg. Each BRAFTOVI 75 mg hard capsule contains encorafenib 75 mg. For the list of excipients, see section 6.1 List of excipients. 3. PHARMACEUTICAL FORM BRAFTOVI 50 mg hard capsules Swedish orange opaque cap and flesh-coloured opaque body, printed with a stylised “A” on the cap and “LGX 50 mg” 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 75 mg” on the body. The length of the capsule is approximately 23 mm. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Melanoma Encorafenib, in combination with binimetinib, is indicated for the treatment of adult patients who have unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by a validated test. Colorectal Cancer Encorafenib, in combination with cetuximab, is indicated for the treatment of adult patients BRAFTOVI – PI January 2024 Page 2 sur 46 who have metastatic colorectal cancer (mCRC) with a BRAF V600E mutation as detected by a validated test, and who have received prior systemic therapy. BRAFTOVI – PI January 2024 Page 3 sur 46 4.2. DOSE AND METHOD OF ADMINISTRATION Treatment with encorafenib should only be initiated and supervised by a physician experienced in the use of anti-cancer medicines. Patient selection Prior to treatment with encorafenib, the BRAF V600 mutation status of a patient’s melanoma or colorectal cancer must be confirmed by a validated te اقرأ الوثيقة كاملة