IRINOTECAN HYDROCHLORIDE injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

IRINOTECAN HYDROCHLORIDE (UNII: 042LAQ1IIS) (IRINOTECAN - UNII:7673326042)

Available from:

Hikma Pharmaceuticals USA Inc.

INN (International Name):

IRINOTECAN HYDROCHLORIDE

Composition:

IRINOTECAN HYDROCHLORIDE 20 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Irinotecan Hydrochloride Injection, USP is available in single-dose amber glass vials in the following package sizes:  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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

IRINOTECAN HYDROCHLORIDE- IRINOTECAN HYDROCHLORIDE INJECTION
HIKMA PHARMACEUTICALS USA INC.
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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