#高警訊藥品

與oxaliplatin、5-fluorouracil和leucovorin併用，作為轉移性胰腺癌成人病人的第一線治療。<20241129>

與5-fuorouracil 和leucovorin併用，治療曾接受過gemcitabine的轉移性胰腺癌成人病人。

Used in combination with oxaliplatin, 5-fluorouracil, and leucovorin as a first-line treatment for adults with metastatic pancreatic cancer.
Used in combination with 5-fluorouracil and leucovorin for the treatment of adults with metastatic pancreatic cancer who have previously received gemcitabine.

Antineoplastic Agent, Camptothecin; Topoisomerase I Inhibitor
Irinotecan and its active metabolite (SN-38) bind reversibly to topoisomerase I-DNA complex preventing re-ligation of the cleaved DNA strand. This results in the accumulation of cleavable complexes and double-strand DNA breaks. As mammalian cells cannot efficiently repair these breaks, cell death consistent with S-phase cell cycle specificity occurs, leading to termination of cellular replication.

1. Distribution: Vd: 4.1 L
2. Metabolism: Substrate of CYP3A4 and UGT1A1
3. Elimination Half Life: 25.8 hours

Severe hypersensitivity reaction to irinotecan liposome or irinotecan hydrochloride

Fetal risk cannot be ruled out. (TH)

Infant risk cannot be ruled out.(MDX)

Common:
Endocrine metabolic: Hypoalbuminemia, Hypocalcemia, Hypokalemia, Hypomagnesemia
Gastrointestinal: Decrease in appetite, Diarrhea, Nausea, Stomatitis, Vomiting
Hematologic: Anemia, Thrombocytopenia
Hepatic: ALT/SGPT level raised
Neurologic: Asthenia
Other: Fatigue, Fever
Serious:
Hematologic: Febrile neutropenia, Febrile neutropenia, Lymphocytopenia, Neutropenia, Neutropenic sepsis
Immunologic: Hypersensitivity reaction, Septic shock
Renal: Acute renal failure
Respiratory: Interstitial lung disease, Pneumonia

1. Usual dose: IV 70 mg/m2 once every 2 weeks (in combination with fluorouracil and leucovorin).
2. Reduce initial starting dose to 50 mg/m2 in patients known to be homozygous for the UGT1A1*28 allele; the dose may be increased to 70 mg/m2 as tolerated in subsequent cycles.

Safety and efficacy have not been established in pediatric patients.

There are no dosage adjustments provided in the manufacturer's labeling (insufficient data)

Bilirubin >ULN: There are no dosage adjustments provided in the manufacturer's labeling; use with caution; No data are available regarding use in patients with bilirubin >2 mg/dL.