Irinotecan

FDA Drug Profile

Drug Details

Generic Name
Irinotecan
Brand Names
N/A
Application Number
Sponsor
Hetero Labs Limited
NDC Codes
1
Dosage Forms
POWDER
Routes
N/A
Active Ingredients
IRINOTECAN HYDROCHLORIDE

Indications and Usage

1 INDICATIONS AND USAGE Irinotecan hydrochloride injection is indicated as a component of first-line therapy in combination with 5-fluorouracil (5-FU) and leucovorin (LV) for patients with metastatic carcinoma of the colon or rectum. Irinotecan hydrochloride injection is indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy. Irinotecan hydrochloride injection is a topoisomerase inhibitor indicated for: • First-line therapy in combination with 5-fluorouracil and leucovorin for patients with metastatic carcinoma of the colon or rectum. ( 1 ) • Patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy. ( 1 )