Lonsurf
Country: ﾐ片ｲﾑﾐｾﾐｿﾑﾐｺﾐｰ ﾐ｣ﾐｽﾐｸﾑ侑ｰ
ﾐ威ｵﾐｷﾐｸﾐｺ: ﾐ帯σｳﾐｰﾑﾑﾐｺﾐｸ
ﾐ侑ｷﾐｲﾐｾﾑ: EMA (European Medicines Agency)
ﾐ侑ｽﾑﾐｾﾑﾐｼﾐｰﾑひｸﾐｲﾐｽﾐｸ ﾐｻﾐｵﾑひｰﾐｺ
(PIL)
11-09-2023
ﾐ墟ｰﾑﾐｰﾐｺﾑひｵﾑﾐｸﾑﾑひｸﾐｺﾐｵ ﾐｿﾑﾐｾﾐｸﾐｷﾐｲﾐｾﾐｴﾐｰ
(SPC)
11-09-2023
ﾐ侑ｷﾐｲﾐｵﾑ尉ひｰﾑ ﾐｾ ﾐｿﾑﾐｾﾑﾐｵﾐｽﾐｸ ﾑ侑ｰﾐｲﾐｽﾐｾﾑﾑひｸ
(PAR)
11-09-2023
ﾐ籍ｺﾑひｸﾐｲﾐｽﾐｸ ﾑﾐｰﾑﾑひｾﾑ侑ｰﾐｺ:
trifluridine, tipiracil ﾑﾐｸﾐｴﾑﾐｾﾑﾐｻﾐｾﾑﾐｸﾐｴ
ﾐ頒ｾﾑﾑびσｿﾐｽﾐｾ ﾐｾﾐｴ:
Les Laboratoires Servier
ﾐ籍｢ﾐｦ ﾐｺﾐｾﾐｴ:
L01BC59
INN (ﾐ慴ｵﾑ柘σｽﾐｰﾑﾐｾﾐｴﾐｽﾐｾ ﾐｸﾐｼﾐｵ):
trifluridine, tipiracil
ﾐ｢ﾐｵﾑﾐｰﾐｿﾐｵﾑτびﾐｺﾐｰ ﾐｳﾑﾑσｿﾐｰ:
ﾐ籍ｽﾑひｸﾐｽﾐｵﾐｾﾐｿﾐｻﾐｰﾑﾑひｸﾑﾐｽﾐｸ ﾑﾑﾐｵﾐｴﾑﾑひｲﾐｰ
ﾐ｢ﾐｵﾑﾐｰﾐｿﾐｵﾑτびﾐｺﾐｰ ﾐｾﾐｱﾐｻﾐｰﾑﾑ:
ﾐ墟ｾﾐｻﾐｾﾑﾐｵﾐｺﾑひｰﾐｻﾐｽﾐｸ ﾐｽﾐｵﾐｾﾐｿﾐｻﾐｰﾐｷﾐｼﾐｸ
ﾐ｢ﾐｵﾑﾐｰﾐｿﾐｵﾑτびﾐｺﾐｵ ﾐｸﾐｽﾐｴﾐｸﾐｺﾐｰﾑﾐｸﾑ侑ｵ:
Colorectal cancerLonsurf is indicated in combination with bevacizumab for the treatment of adult patients with metastatic colorectal cancer (CRC) who have received two prior anticancer treatment regimens including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and/or anti-EGFR agents. Lonsurf is indicated as monotherapy 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 agentsGastric cancerLonsurf is indicated as monotherapy for the treatment of adult patients with metastatic gastric cancer including adenocarcinoma of the gastroesophageal junction, who have been previously treated with at least two prior systemic treatment regimens for advanced disease.
ﾐﾐｵﾐｷﾐｸﾐｼﾐｵ ﾐｿﾑﾐｾﾐｸﾐｷﾐｲﾐｾﾐｴﾐｰ:
Revision: 9
ﾐ｡ﾑひｰﾑびτ ﾐｰﾑτひｾﾑﾐｸﾐｷﾐｰﾑﾐｸﾑ侑ｵ:
ﾑσｿﾑ諌ｻﾐｽﾐｾﾐｼﾐｾﾑ禍ｵﾐｽ
ﾐ頒ｰﾑびσｼ ﾐｾﾐｴﾐｾﾐｱﾑﾐｵﾑ墟ｰ:
2016-04-25
ﾐ侑ｽﾑﾐｾﾑﾐｼﾐｰﾑひｸﾐｲﾐｽﾐｸ ﾐｻﾐｵﾑひｰﾐｺ
41
ﾐ. ﾐ嶢侑｡ﾐ｢ﾐ榧漬墟
42
ﾐ嶢侑｡ﾐ｢ﾐ榧漬墟: ﾐ侑斷､ﾐ榧ﾐ慴籍ｦﾐ侑ｯ ﾐ厘 ﾐ渙籍ｦﾐ侑片斷｢ﾐ
LONSURF 15 MG/6,14 MG ﾐ､ﾐ侑嶢慴侑ﾐ籍斷 ﾐ｢ﾐ籍岱嶢片｢ﾐ墟
LONSURF 20 MG/8,19 MG ﾐ､ﾐ侑嶢慴侑ﾐ籍斷 ﾐ｢ﾐ籍岱嶢片｢ﾐ墟
ﾑびﾐｸﾑﾐｻﾑτﾐｸﾐｴﾐｸﾐｽ/ﾑひｸﾐｿﾐｸﾑﾐｰﾑﾐｸﾐｻ
(trifluridine/tipiracil)
.
ﾐ渙ﾐ榧ｧﾐ片｢ﾐ片｢ﾐ ﾐ漬斷侑慴籍｢ﾐ片嶢斷 ﾐｦﾐｯﾐ嶢籍｢ﾐ ﾐ嶢侑｡ﾐ｢ﾐ榧漬墟,
ﾐ渙ﾐ片頒 ﾐ頒 ﾐ厘籍渙榧ｧﾐ斷片｢ﾐ ﾐ頒 ﾐ渙ﾐ侑片慴籍｢ﾐ ﾐ｢ﾐ榧漬
ﾐ嶢片墟籍ﾐ｡ﾐ｢ﾐ漬,
ﾐ｢ﾐｪﾐ ﾐ墟籍｢ﾐ ﾐ｢ﾐｯ ﾐ｡ﾐｪﾐ頒ｪﾐﾐ孟 ﾐ漬籍孟斷 ﾐ厘 ﾐ漬籍｡
ﾐ侑斷､ﾐ榧ﾐ慴籍ｦﾐ侑ｯ.
窶｢
ﾐ厘ｰﾐｿﾐｰﾐｷﾐｵﾑひｵ ﾑひｰﾐｷﾐｸ ﾐｻﾐｸﾑﾑひｾﾐｲﾐｺﾐｰ. ﾐ慴ｾﾐｶﾐｵ ﾐｴﾐｰ ﾑﾐｵ
ﾐｽﾐｰﾐｻﾐｾﾐｶﾐｸ ﾐｴﾐｰ ﾑ ﾐｿﾑﾐｾﾑﾐｵﾑひｵﾑひｵ ﾐｾﾑひｽﾐｾﾐｲﾐｾ.
窶｢
ﾐ籍ｺﾐｾ ﾐｸﾐｼﾐｰﾑひｵ ﾐｽﾑ紹ｺﾐｰﾐｺﾐｲﾐｸ ﾐｴﾐｾﾐｿﾑ諌ｻﾐｽﾐｸﾑひｵﾐｻﾐｽﾐｸ
ﾐｲﾑ諌ｿﾑﾐｾﾑﾐｸ, ﾐｿﾐｾﾐｿﾐｸﾑひｰﾐｹﾑひｵ ﾐ漬ｰﾑ威ｸﾑ ﾐｻﾐｵﾐｺﾐｰﾑ ﾐｸﾐｻﾐｸ
ﾑﾐｰﾑﾐｼﾐｰﾑﾐｵﾐｲﾑ.
_ _
窶｢
ﾐ｢ﾐｾﾐｲﾐｰ ﾐｻﾐｵﾐｺﾐｰﾑﾑﾑひｲﾐｾ ﾐｵ ﾐｿﾑﾐｵﾐｴﾐｿﾐｸﾑﾐｰﾐｽﾐｾ ﾐｻﾐｸﾑﾐｽﾐｾ ﾐｽﾐｰ
ﾐ漬ｰﾑ. ﾐ斷ｵ ﾐｳﾐｾ ﾐｿﾑﾐｵﾐｾﾑびﾑび諌ｿﾐｲﾐｰﾐｹﾑひｵ ﾐｽﾐｰ ﾐｴﾑﾑσｳﾐｸ
ﾑﾐｾﾑﾐｰ. ﾐ｢ﾐｾ ﾐｼﾐｾﾐｶﾐｵ ﾐｴﾐｰ
ﾐｸﾐｼ ﾐｽﾐｰﾐｲﾑﾐｵﾐｴﾐｸ, ﾐｽﾐｵﾐｷﾐｰﾐｲﾐｸﾑﾐｸﾐｼﾐｾ ﾑﾐｵ ﾐｿﾑﾐｸﾐｷﾐｽﾐｰﾑﾐｸﾑひｵ
ﾐｽﾐｰ ﾑび肖ﾐｽﾐｾﾑひｾ ﾐｷﾐｰﾐｱﾐｾﾐｻﾑ紹ｲﾐｰﾐｽﾐｵ ﾑﾐｰ ﾑﾑ貫禍ｸﾑひｵ ﾐｺﾐｰﾑひｾ
ﾐ漬ｰﾑ威ｸﾑひｵ.
_ _
窶｢
ﾐ籍ｺﾐｾ ﾐｿﾐｾﾐｻﾑτﾐｸﾑひｵ ﾐｽﾑ紹ｺﾐｰﾐｺﾐｲﾐｸ ﾐｽﾐｵﾐｶﾐｵﾐｻﾐｰﾐｽﾐｸ
ﾐｻﾐｵﾐｺﾐｰﾑﾑﾑひｲﾐｵﾐｽﾐｸ ﾑﾐｵﾐｰﾐｺﾑﾐｸﾐｸ, ﾑσｲﾐｵﾐｴﾐｾﾐｼﾐｵﾑひｵ ﾐ漬ｰﾑ威ｸﾑ
ﾐｻﾐｵﾐｺﾐｰﾑ ﾐｸﾐｻﾐｸ
ﾑﾐｰﾑﾐｼﾐｰﾑﾐｵﾐｲﾑ. ﾐ｢ﾐｾﾐｲﾐｰ ﾐｲﾐｺﾐｻﾑ紗ﾐｲﾐｰ ﾐｸ ﾐｲﾑﾐｸﾑﾐｺﾐｸ
ﾐｲﾑ諌ｷﾐｼﾐｾﾐｶﾐｽﾐｸ ﾐｽﾐｵﾐｶﾐｵﾐｻﾐｰﾐｽﾐｸ ﾑﾐｵﾐｰﾐｺﾑﾐｸﾐｸ, ﾐｽﾐｵﾐｾﾐｿﾐｸﾑﾐｰﾐｽﾐｸ
ﾐｲ ﾑひｰﾐｷﾐｸ ﾐｻﾐｸﾑﾑひｾﾐｲﾐｺﾐｰ.
ﾐ漬ｸﾐｶﾑひｵ ﾑひｾﾑﾐｺﾐｰ 4.
ﾐ墟籍墟漬 ﾐ｡ﾐｪﾐ頒ｪﾐﾐ孟 ﾐ｢ﾐ籍厘 ﾐ嶢侑｡ﾐ｢ﾐ榧漬墟
1.
ﾐ墟ｰﾐｺﾐｲﾐｾ ﾐｿﾑﾐｵﾐｴﾑﾑひｰﾐｲﾐｻﾑ紹ｲﾐｰ Lonsurf ﾐｸ ﾐｷﾐｰ ﾐｺﾐｰﾐｺﾐｲﾐｾ ﾑﾐｵ
ﾐｸﾐｷﾐｿﾐｾﾐｻﾐｷﾐｲﾐｰ
2.
ﾐ墟ｰﾐｺﾐｲﾐｾ ﾑびﾑ紹ｱﾐｲﾐｰ ﾐｴﾐｰ ﾐｷﾐｽﾐｰﾐｵﾑひｵ, ﾐｿﾑﾐｵﾐｴﾐｸ ﾐｴﾐｰ
ﾐｿﾑﾐｸﾐｵﾐｼﾐｵﾑひｵ Lonsurf
3.
ﾐ墟ｰﾐｺ ﾐｴﾐｰ ﾐｿﾑﾐｸﾐｵﾐｼﾐｰﾑひｵ Lonsurf
4.
ﾐ柘諌ｷﾐｼﾐｾﾐｶﾐｽﾐｸ ﾐｽﾐｵﾐｶﾐｵﾐｻﾐｰﾐｽﾐｸ ﾑﾐｵﾐｰﾐｺﾑﾐｸﾐｸ
5.
ﾐ墟ｰﾐｺ ﾐｴﾐｰ ﾑﾑ貫ﾑﾐｰﾐｽﾑ紹ｲﾐｰﾑひｵ Lonsurf
6.
ﾐ｡ﾑ諌ｴﾑ貫ﾐｶﾐｰﾐｽﾐｸﾐｵ ﾐｽﾐｰ ﾐｾﾐｿﾐｰﾐｺﾐｾﾐｲﾐｺﾐｰﾑひｰ ﾐｸ
ﾐｴﾐｾﾐｿﾑ諌ｻﾐｽﾐｸﾑひｵﾐｻﾐｽﾐｰ ﾐｸﾐｽﾑﾐｾﾑﾐｼﾐｰﾑﾐｸﾑ
1.
ﾐ墟籍墟漬 ﾐ渙ﾐ片頒｡ﾐ｢ﾐ籍漬嶢ｯﾐ漬 LONSURF ﾐ ﾐ厘 ﾐ墟籍墟漬 ﾐ｡ﾐ
ﾐ侑厘渙榧嶢厘漬
Lonsurf ﾐｵ ﾐｲﾐｸﾐｴ ﾐｿﾑﾐｾﾑひｸﾐｲﾐｾﾑﾐｰﾐｺﾐｾﾐｲﾐｾ
ﾑﾐｸﾐｼﾐｸﾐｾﾑひｵﾑﾐｰﾐｿ
ﾐ湲ﾐｾﾑﾐｸﾑひｰﾑ佯ひｵ ﾐｺﾐｾﾐｼﾐｿﾐｻﾐｵﾑひｰﾐｽ ﾐｴﾐｾﾐｺﾑσｼﾐｵﾐｽﾑ
ﾐ墟ｰﾑﾐｰﾐｺﾑひｵﾑﾐｸﾑﾑひｸﾐｺﾐｵ ﾐｿﾑﾐｾﾐｸﾐｷﾐｲﾐｾﾐｴﾐｰ
1
ﾐ渙ﾐ侑嶢榧孟片斷侑 ﾐ
ﾐ墟ﾐ籍｢ﾐ墟 ﾐ･ﾐ籍ﾐ籍墟｢ﾐ片ﾐ侑｡ﾐ｢ﾐ侑墟 ﾐ斷 ﾐ渙ﾐ榧頒｣ﾐ墟｢ﾐ
2
1.
ﾐ侑慴 ﾐ斷 ﾐ嶢片墟籍ﾐ｡ﾐ｢ﾐ漬片斷侑ｯ ﾐ渙ﾐ榧頒｣ﾐ墟｢
Lonsurf 15 mg/6,14 mg ﾑﾐｸﾐｻﾐｼﾐｸﾑﾐｰﾐｽﾐｸ ﾑひｰﾐｱﾐｻﾐｵﾑひｺﾐｸ
Lonsurf 20 mg/8,19 mg ﾑﾐｸﾐｻﾐｼﾐｸﾑﾐｰﾐｽﾐｸ ﾑひｰﾐｱﾐｻﾐｵﾑひｺﾐｸ
2.
ﾐ墟籍ｧﾐ片｡ﾐ｢ﾐ漬片 ﾐ ﾐ墟榧嶢侑ｧﾐ片｡ﾐ｢ﾐ漬片 ﾐ｡ﾐｪﾐ｡ﾐ｢ﾐ籍
Lonsurf 15 mg/6,14 mg ﾑﾐｸﾐｻﾐｼﾐｸﾑﾐｰﾐｽﾐｸ ﾑひｰﾐｱﾐｻﾐｵﾑひｺﾐｸ
ﾐ柘ﾑ紹ｺﾐｰ ﾑﾐｸﾐｻﾐｼﾐｸﾑﾐｰﾐｽﾐｰ ﾑひｰﾐｱﾐｻﾐｵﾑひｺﾐｰ ﾑﾑ諌ｴﾑ貫ﾐｶﾐｰ 15 mg
ﾑびﾐｸﾑﾐｻﾑτﾐｸﾐｴﾐｸﾐｽ (trifluridine) ﾐｸ 6,14 mg ﾑひｸﾐｿﾐｸﾑﾐｰﾑﾐｸﾐｻ
(tipiracil ) (ﾐｿﾐｾﾐｴ ﾑﾐｾﾑﾐｼﾐｰﾑひｰ ﾐｽﾐｰ ﾑﾐｸﾐｴﾑﾐｾﾑﾐｻﾐｾﾑﾐｸﾐｴ).
_ﾐ渙ｾﾐｼﾐｾﾑ禍ｽﾐｾ ﾐｲﾐｵﾑ禍ｵﾑﾑひｲﾐｾ ﾑ ﾐｸﾐｷﾐｲﾐｵﾑﾑひｽﾐｾ ﾐｴﾐｵﾐｹﾑﾑひｲﾐｸﾐｵ
_
ﾐ柘ﾑ紹ｺﾐｰ ﾑﾐｸﾐｻﾐｼﾐｸﾑﾐｰﾐｽﾐｰ ﾑひｰﾐｱﾐｻﾐｵﾑひｺﾐｰ ﾑﾑ諌ｴﾑ貫ﾐｶﾐｰ 90,735
mg ﾐｻﾐｰﾐｺﾑひｾﾐｷﾐｰ ﾐｼﾐｾﾐｽﾐｾﾑﾐｸﾐｴﾑﾐｰﾑ.
Lonsurf 20 mg/8,19 mg ﾑﾐｸﾐｻﾐｼﾐｸﾑﾐｰﾐｽﾐｸ ﾑひｰﾐｱﾐｻﾐｵﾑひｺﾐｸ
ﾐ柘ﾑ紹ｺﾐｰ ﾑﾐｸﾐｻﾐｼﾐｸﾑﾐｰﾐｽﾐｰ ﾑひｰﾐｱﾐｻﾐｵﾑひｺﾐｰ ﾑﾑ諌ｴﾑ貫ﾐｶﾐｰ 20 mg
ﾑびﾐｸﾑﾐｻﾑτﾐｸﾐｴﾐｸﾐｽ (trifluridine) ﾐｸ 8,19 mg ﾑひｸﾐｿﾐｸﾑﾐｰﾑﾐｸﾐｻ
(tipiracil) (ﾐｿﾐｾﾐｴ ﾑﾐｾﾑﾐｼﾐｰﾑひｰ ﾐｽﾐｰ ﾑﾐｸﾐｴﾑﾐｾﾑﾐｻﾐｾﾑﾐｸﾐｴ).
_ﾐ渙ｾﾐｼﾐｾﾑ禍ｽﾐｾ ﾐｲﾐｵﾑ禍ｵﾑﾑひｲﾐｾ ﾑ ﾐｸﾐｷﾐｲﾐｵﾑﾑひｽﾐｾ ﾐｴﾐｵﾐｹﾑﾑひｲﾐｸﾐｵ
_
ﾐ柘ﾑ紹ｺﾐｰ ﾑﾐｸﾐｻﾐｼﾐｸﾑﾐｰﾐｽﾐｰ ﾑひｰﾐｱﾐｻﾐｵﾑひｺﾐｰ ﾑﾑ諌ｴﾑ貫ﾐｶﾐｰ 120,980
mg ﾐｻﾐｰﾐｺﾑひｾﾐｷﾐｰ ﾐｼﾐｾﾐｽﾐｾﾑﾐｸﾐｴﾑﾐｰﾑ.
ﾐ厘ｰ ﾐｿﾑ諌ｻﾐｽﾐｸﾑ ﾑﾐｿﾐｸﾑﾑ諌ｺ ﾐｽﾐｰ ﾐｿﾐｾﾐｼﾐｾﾑ禍ｽﾐｸﾑひｵ
ﾐｲﾐｵﾑ禍ｵﾑﾑひｲﾐｰ ﾐｲﾐｸﾐｶﾑひｵ ﾑひｾﾑﾐｺﾐｰ 6.1.
3.
ﾐ嶢片墟籍ﾐ｡ﾐ｢ﾐ漬片斷 ﾐ､ﾐ榧ﾐ慴
ﾐ､ﾐｸﾐｻﾐｼﾐｸﾑﾐｰﾐｽﾐｰ ﾑひｰﾐｱﾐｻﾐｵﾑひｺﾐｰ (ﾑひｰﾐｱﾐｻﾐｵﾑひｺﾐｰ)
Lonsurf 15 mg/6,14 mg ﾑﾐｸﾐｻﾐｼﾐｸﾑﾐｰﾐｽﾐｸ ﾑひｰﾐｱﾐｻﾐｵﾑひｺﾐｸ
ﾐ｢ﾐｰﾐｱﾐｻﾐｵﾑひｺﾐｰﾑひｰ ﾐｵ ﾑﾐｸﾐｻﾐｼﾐｸﾑﾐｰﾐｽﾐｰ, ﾐｱﾑ紹ｻﾐｰ,
ﾐｴﾐｲﾐｾﾐｹﾐｽﾐｾﾐｸﾐｷﾐｿﾑ諌ｺﾐｽﾐｰﾐｻﾐｰ, ﾑ ﾐｺﾑﾑ諌ｳﾐｻﾐｰ ﾑﾐｾﾑﾐｼﾐｰ, ﾑ
ﾐｴﾐｸﾐｰﾐｼﾐｵﾑび貫 7,1 mm ﾐｸ
ﾐｴﾐｵﾐｱﾐｵﾐｻﾐｸﾐｽﾐｰ 2,7 mm. ﾐ樮 ﾐｵﾐｴﾐｽﾐｰﾑひｰ ﾑﾑびﾐｰﾐｽﾐｰ ﾑﾑ貫
ﾑﾐｸﾐｲﾐｾ ﾐｼﾐｰﾑﾑひｸﾐｻﾐｾ ﾐｽﾐｰ ﾑひｰﾐｱﾐｻﾐｵﾑひｺﾐｰﾑひｰ ﾐｵ
ﾐｾﾑひｿﾐｵﾑﾐｰﾑひｰﾐｽﾐｾ 窶15窶, ﾐｰ ﾐｾﾑ
ﾐｴﾑﾑσｳﾐｰﾑひｰ ﾑﾑびﾐｰﾐｽﾐｰ -窶102窶 ﾐｸ 窶15 mg窶.
Lonsurf 20 mg/8,19 mg ﾑﾐｸﾐｻﾐｼﾐｸﾑﾐｰﾐｽﾐｸ ﾑひｰﾐｱﾐｻﾐｵﾑひｺﾐｸ
ﾐ｢ﾐｰﾐｱﾐｻﾐｵﾑひｺﾐｰﾑひｰ ﾐｵ ﾑﾐｸﾐｻﾐｼﾐｸﾑﾐｰﾐｽﾐｰ, ﾐｱﾐｻﾐｵﾐｴﾐｾﾑﾐｵﾑﾐｲﾐｵﾐｽﾐｰ,
ﾐｴﾐｲﾐｾﾐｹﾐｽﾐｾﾐｸﾐｷﾐｿﾑ諌ｺﾐｽﾐｰﾐｻﾐｰ, ﾑ ﾐｺﾑﾑ諌ｳﾐｻﾐｰ ﾑﾐｾﾑﾐｼﾐｰ, ﾑ
ﾐｴﾐｸﾐｰﾐｼﾐｵﾑび貫 7,6 mm ﾐｸ
ﾐｴﾐｵﾐｱﾐｵﾐｻﾐｸﾐｽﾐｰ 3,2
ﾐ湲ﾐｾﾑﾐｸﾑひｰﾑ佯ひｵ ﾐｺﾐｾﾐｼﾐｿﾐｻﾐｵﾑひｰﾐｽ ﾐｴﾐｾﾐｺﾑσｼﾐｵﾐｽﾑ
