Šalis: Singapūras
kalba: anglų
Šaltinis: HSA (Health Sciences Authority)
Binimetinib
PIERRE FABRE SINGAPORE PTE LTD
L01EE03
TABLET, FILM COATED
Binimetinib 15mg
ORAL
Prescription Only
ALMAC Pharma Services Limited
ACTIVE
2023-07-19
XXXXX XXXXX 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 1. NAME OF THE MEDICINE Binimetinib 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each MEKTOVI film-coated tablet contains binimetinib 15mg. Contains lactose. Contains sugars. For a full list of excipients, see section 6.1 _List of excipients_. 3. PHARMACEUTICAL FORM MEKTOVI 15 mg film-coated tablets are yellow/dark yellow, unscored biconvex, ovaloid film-coated tablets, approximately 12 mm in length and 5 mm in width, with the “A” logo debossed on one face of the tablet and “15” on the opposing face. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Binimetinib in combination with encorafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by a validated test. 4.2. DOSE AND METHOD OF ADMINISTRATION Treatment with binimetinib in combination with encorafenib should only be initiated and supervised by a physician experienced in the use of anti-cancer medicines. DOSAGE Patients treated with binimetinib in combination with encorafenib must have their BRAF V600 mutant melanoma status confirmed by a validated test conducted by an experienced laboratory (see 5.1 Clinical Trials). The recommended dose of binimetinib is 45 mg (three 15 mg tablets) twice daily (corresponding to a total dose of 90 mg), approximately 12 hours apart, when used in combination with encorafenib. ADMINISTRATION Binimetinib tablets should be swallowed whole with water, with or without food. DURATION OF TREATMENT Treatment should continue until the patient no longer derives benefit or unacceptable toxicity develops. MISSED DOSE If a dose of binimetinib is missed, it should not be taken if it is less than 6 hours until the next dose is due. V Perskaitykite visą dokumentą