Country: United States
Language: English
Source: NLM (National Library of Medicine)
IRINOTECAN HYDROCHLORIDE (UNII: 042LAQ1IIS) (IRINOTECAN - UNII:7673326042)
Hikma Pharmaceuticals USA Inc.
IRINOTECAN HYDROCHLORIDE
IRINOTECAN HYDROCHLORIDE 20 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
Irinotecan Hydrochloride Injection, USP 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 contraindicated in patients with a known hypersensitivity to the drug or its excipients. Risk Summary Based on findings from animal studies and its mechanism of action, irinotecan hydrochloride injection can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)] . Available postmarketing and published data reporting the use of irinotecan hydrochloride injection in pregnant women, are insufficient and confounded by the concomitant use of other cytotoxic drugs, to evaluate for any drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal studies, intravenous administration of irinotecan to rats and rabbits during the period of organogenesis resulted in embryofetal mortality and teratogenicity
Irinotecan Hydrochloride Injection, USP is available in single-dose amber glass vials in the following package sizes: 40 mg/2 mL Store at 20° to 25° C (68° to 77° F). See USP Controlled Room Temperature (excursions permitted to 15° to 30° C (59°to 86° F)). Protect from light. Keep the vial in the carton until the time of use. Protect from freezing. Inspect the vial for damage and visible signs of leaks before removing from the carton. If damaged, incinerate the unopened package.
Abbreviated New Drug Application
IRINOTECAN HYDROCHLORIDE- IRINOTECAN HYDROCHLORIDE INJECTION HIKMA PHARMACEUTICALS USA INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE IRINOTECAN HYDROCHLORIDE INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR IRINOTECAN HYDROCHLORIDE INJECTION, USP. IRINOTECAN HYDROCHLORIDE INJECTION, USP INITIAL U.S. APPROVAL: 1996 WARNING: DIARRHEA AND MYELOSUPPRESSION _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ EARLY AND LATE FORMS OF DIARRHEA CAN OCCUR. EARLY DIARRHEA MAY BE ACCOMPANIED BY CHOLINERGIC SYMPTOMS WHICH MAY BE PREVENTED OR AMELIORATED BY ATROPINE. LATE DIARRHEA CAN BE LIFE THREATENING AND SHOULD BE TREATED PROMPTLY WITH LOPERAMIDE. MONITOR PATIENTS WITH DIARRHEA AND GIVE FLUID AND ELECTROLYTES AS NEEDED. INSTITUTE ANTIBIOTIC THERAPY IF PATIENTS DEVELOP ILEUS, FEVER, OR SEVERE NEUTROPENIA. INTERRUPT IRINOTECAN HYDROCHLORIDE INJECTION AND REDUCE SUBSEQUENT DOSES IF SEVERE DIARRHEA OCCURS. (2.1, 5.1) SEVERE MYELOSUPPRESSION MAY OCCUR. (5.2) RECENT MAJOR CHANGES Warnings and Precautions, Embryo-Fetal Toxicity (5.9) 01/2020 INDICATIONS AND USAGE Irinotecan Hydrochloride Injection, USP is a topoisomerase inhibitor indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy. (1) DOSAGE AND ADMINISTRATION Colorectal cancer single agent regimen 1: irinotecan hydrochloride injection 125 mg/m intravenous infusion over 90 minutes on days 1, 8, 15, 22 then 2-week rest. (2.1) Colorectal cancer single agent regimen 2: irinotecan hydrochloride injection 350 mg/m intravenous infusion over 90 minutes on day 1 every 3 weeks. (2.1) DOSAGE FORMS AND STRENGTHS Irinotecan hydrochloride injection is available in two single-dose sizes: (3) 2 mL-fill vial containing 40 mg irinotecan hydrochloride injection 5 mL-fill vial containing 100 mg irinotecan hydrochloride injection CONTRAINDICATIONS Hypersensitivity to irinotecan hydrochlor Read the complete document