LONSURF 15 MG / 6.14 MG

Land: Indonesien

Språk: indonesiska

Källa: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Enheter i paketet:

KARTON, 60 DUS @ 1 SACHET FOIL @ 2 BLISTER @ 10 TABLET SALUT SELA...

Tillstånd datum:

2022-06-28

Produktens egenskaper

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