Country: Indoneżja
Lingwa: Indoneżjan
Sors: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
DUS, 1 SACHET FOIL @ 2 BLISTER @ 10 TABLET SALUT SELAPUT
2022-06-28
1 1. NAME OF THE MEDICINAL PRODUCT Lonsurf ® Film-coated Tablet 15 mg/6.14 mg Lonsurf ® Film-coated Tablet 20 mg/8.19 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Lonsurf ® Film-coated Tablet 15 mg/6.14 mg Each film-coated tablet contains 15 mg trifluridine and 6.14 mg tipiracil (as hydrochloride). Lonsurf ® Film-coated Tablet 20 mg/8.19 mg Each film-coated tablet contains 20 mg trifluridine and 8.19 mg tipiracil (as hydrochloride). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Lonsurf ® Film-coated Tablet 15 mg/6.14 mg The tablet is a white, biconvex, round, film-coated tablet, with ‘15’ on one side, and ‘102’ and ‘15 mg’ on the other side, in grey ink. Lonsurf ® Film-coated Tablet 20 mg/8.19 mg The tablet is a pale red, biconvex, round, film-coated tablet, with ‘20’ on one side, and ‘102’ and ‘20 mg’ on the other side, in grey ink. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Lonsurf ® is indicated for the treatment of patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti- VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Lonsurf ® should be prescribed by physicians experienced in the administration of anticancer therapy. Posology The recommended starting dose of Lonsurf ® in adults is 35 mg/m 2 /dose administered orally twice daily on Days 1 to 5 and Days 8 to 12 of each 28-day cycle as long as benefit is observed or until unacceptable toxicity occurs (see section 4.4). The dosage is calculated according to body surface area (BSA) (see Table 1). The dosage must not DISETUJUI OLEH BPOM: 06/06/2022 ID: EREG10021911900010, EREG10021911900064 EREG10021911900065, EREG10021911900066 2 exceed 80 mg/dose. Instruct patients to swallow Lonsurf ® tablets whole. Instruct patients not to retake doses of Lonsurf ® that are vomited or missed and to continue with the Aqra d-dokument sħiħ