Each mL contains irinotecan hydrochloride trihydrate 20 mg, water for injection USP 1 mL.
Irinotecan hydrochloride trihydrate solution for injection is an antineoplastic agent of topoisomerase I inhibitor class. Irinotecan hydrochloride was clinically investigated as CPT-II. It is supplied as a clear colorless to light pale yellow solution.
It is available in a single-dose size of 5 mL-fill vials or 2 mL-fill vials containing 100 mg or 40 mg of irinotecan hydrochloride trihydrate.
The pH of the solution has been adjusted to 3.5 (range 3.0 to 3.8) with sodium-hydroxide or hydrochloric-acid.
Irinotecan is intended for dilution with 5% dextrose injection (USP) or 0.9% sodium-chloride injection (USP) prior to intravenous infusion. The preferred diluent is 5% dextrose injection (USP).