Lonsurf 15 mg/6.14 mg film-coated tablets
Lonsurf 20 mg/8.19 mg film-coated tablets
Lonsurf 15 mg/6.14 mg film-coated tablets
Each film-coated tablet contains 15 mg trifluridine and 6.14 mg tipiracil (as hydrochloride).
Excipient with known effect
Each film-coated tablet contains 90.735 mg of lactose monohydrate.
Lonsurf 20 mg/8.19 mg film-coated tablets
Each film-coated tablet contains 20 mg trifluridine and 8.19 mg tipiracil (as hydrochloride).
Excipient with known effect
Each film-coated tablet contains 120.980 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
Film-coated tablet (tablet).
Lonsurf 15 mg/6.14 mg film-coated tablets
The tablet is a white, biconvex, round, film-coated tablet, with a diameter of 7.1 mm and a thickness of 2.7 mm, imprinted with '15' on one side, and '102' and '15 mg' on the other side, in grey ink.
Lonsurf 20 mg/8.19 mg film-coated tablets
The tablet is a pale red, biconvex, round, film-coated tablet, with a diameter of 7.6 mm and a thickness of 3.2 mm, imprinted with '20' on one side, and '102' and '20 mg' on the other side, in grey ink.
Lonsurf is indicated for the treatment of adult patients with metastatic colorectal cancer (CRC) who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents.
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/m2/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 be rounded to the nearest 5 mg increment. The dosage must not exceed 80 mg/dose.
If doses were missed or held, the patient must not make up for missed doses.
Table 1 - Starting dose calculation according to body surface area (BSA)
|
Starting dose
|
BSA
(m2)
|
Dose in mg
(2x daily)
|
Tablets per dose
|
Total daily
dose (mg)
|
|
15 mg
|
20 mg
|
|
35 mg/m2
|
< 1.07
|
35
|
1
|
1
|
70
|
|
1.07 - 1.22
|
40
|
0
|
2
|
80
|
|
1.23 - 1.37
|
45
|
3
|
0
|
90
|
|
1.38 - 1.52
|
50
|
2
|
1
|
100
|
|
1.53 - 1.68
|
55
|
1
|
2
|
110
|
|
1.69 - 1.83
|
60
|
0
|
3
|
120
|
|
1.84 - 1.98
|
65
|
3
|
1
|
130
|
|
1.99 - 2.14
|
70
|
2
|
2
|
|
| 以下是“全球医药”详细资料 |
|
|
