#高警訊藥品

轉移性大腸直腸癌、轉移性胰臟癌
Colorectal cancer (metastatic):
1. First-line therapy in combination with (1) Capecitabine (2) Fluorouracil, leucovorin, and bevacizumab (3) Cetuximab
2. Recurrent disease following initial fluorouracil-based treatment
Pancreatic cancer (metastatic):
First-line therapy in combination with Fluorouracil, leucovorin, and oxaliplatin [FOLFIRINOX]<20210907>

#仿單變更2021

Antineoplastic Agent, Topoisomerase I Inhibitor
Irinotecan hydrochloride, a camptothecin derivative of topoisomerase 1 inhibitor class, prevents religation of single-strand breaks when it binds to topoisomerase 1-DNA complex. Its cytotoxic action is due to the damage in double-strand DNA when replication enzymes act on the formed ternary complex.

Distribution
1. Vd: 110-234 L/m²
2. Protein binding: 30%-68%
Metabolism
Hepatic: Primary, via various enzyme systems
Excretion
Renal: 11% to 20%
Pharmacodynamics
1. Total body clearance: 13.3 to 13.9 L/hr/m²
2. Elimination Half Life: 6 to 12 hours

1. Hypersensitivity to Irinotecan
2. Use with caution in patients with diarrhea, myelosuppression, pregnancy, over 65 y/o

D

Infant risk can not be ruled out.

Neutropenia(dose-limiting), diarrhea(dose-limiting), abdominal cramps, nausea, vomiting, fatigue, hepatic dysfunction, alopecia, skin rash, diaphoresis, flushing, lacrimation, salivation, sensation of warmth, neutropenic sepsis(fatal), pneumonitis(fatal)

Administration
Administer rate for IV should be over 30-90 minutes
Dosage
Colorectal cancer (metastatic)
1. Single therapy: 350 mg/m² once every 3 week
2. Combination with 5-FU/FA: Irinotecam 180 mg/m² once every 2 weeks
Pancreatic cancer (metastatic)
1. [FOLFIRINOX] Oxaliplatin 85 mg/m² for 2 hours, then Leucovorin 400 mg/m² for 2 hours; add 5-FU (IV boulus 400 mg/m² continue with IV infusion 2400 mg/m² for 46 hours) amd Irinotecan 180 mg/m² (for 90 minutes through Y-tube) 30 minutes after Leucovorin administration start.
2. Two weeeks a cycle, total 6 months.<20210907>

1. Renal impairment: Has not been studied; use with caution.
2. Dialysis: Not recommended by the manufacturer; however, literature suggests reducing weekly dose from 125 mg/m² to 50 mg/m² and administer after hemodialysis or on nondialysis days

1. Liver metastases with normal hepatic function: No dosage adjustment necessary.
2. Bilirubin >ULN to ≤2 mg/dL: Consider reducing initial dose by one dose level
3. Bilirubin >2 mg/dL: Use is not recommended

Physical and chemical stability are maintained for 24 hours at room temperature and ambient fluorescent lighting after reconstitution.
Refrigeration of admixtures prepared in 0.9% sodium chloride is not recommended.