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:

Ingenus Pharmaceuticals, LLC

INN (International Name):

IRINOTECAN HYDROCHLORIDE

Composition:

IRINOTECAN HYDROCHLORIDE 40 mg in 2 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

- 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 contraindicated in patients with a known hypersensitivity to the drug or its excipients. Risk Summar y 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, miscarr

Product summary:

Irinotecan hydrochloride injection, USP is available as a sterile, pale yellow, clear, aqueous solution in single-dose amber glass vials in the following individual package sizes: ●   40 mg/2 mL (20 mg/mL)                     NDC  50742-401-02 ●   100 mg/5 mL (20 mg/mL)                   NDC  50742-402-05 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light. Protect from freezing. Keep the vials in the carton until the time of use. Inspect the vial for damage and visible signs of leaks before removing from the carton. If damaged, incinerate the unopened package. Irinotecan hydrochloride injection is a hazardous drug. Follow special handling and disposal procedures.1

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

IRINOTECAN HYDROCHLORIDE - IRINOTECAN HYDROCHLORIDE INJECTION
INGENUS PHARMACEUTICALS, LLC
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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.
IRINOTECAN HYDROCHLORIDE INJECTION, FOR INTRAVENOUS USE
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. (2.2, 5.1)
SEVERE MYELOSUPPRESSION MAY OCCUR. (5.2)
RECENT MAJOR CHANGES
Dosage and Administration, Dosage in Patients With Reduced UGT1A1
Activity (2.3)
1/2022
Dosage and Administration, Preparation of Infusion Solution (2.5)
1/2022
Dosage and Administration, Safe Handling (2.6)
1/2022
Warnings and Precautions, Increased Risk of Neutropenia in Patients
With Reduced UGT1A1 Activity (5.3)
1/2022
INDICATIONS AND USAGE
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)
DOSAGE AND ADMINISTRATION
Colorectal cancer combination regimen 1: Irinotecan hydrochloride
injection 125 mg/m intravenous
infusion over 90 minutes on days 1, 8,15, 22 with LV 20 mg/m
intravenous bolus infusion on days 1, 8,
15, 22 followed