Irinotecan hydrochloide

FDA Drug Profile — Irinotecan hydrochloide

Drug Details

Generic Name
Irinotecan hydrochloide
Brand Names
Irinotecan hydrochloide
Application Number
ANDA212993
Sponsor
BluePoint Laboratories
NDC Codes
3
Dosage Forms
INJECTION
Routes
INTRAVENOUS
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)