irinotecan hydrochloride
Drug Details
- Generic Name
- irinotecan hydrochloride
- Brand Names
- Irinotecan Hydrochloride, Camptosar
- Application Number
- ANDA090675
- Sponsor
- Sagent Pharmaceuticals
- NDC Codes
- 4
- Dosage Forms
- INJECTION, SOLUTION
- 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 )