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:

Areva Pharmaceuticals,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 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, 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. Pregnancy Category D [see Warnings and Precautions (5.9)] Irinotecan hydrochloride injection can cause fetal harm when administered to a pregnant woman. Radioactivity related to 14 C-irinotecan crosses the placenta of rats following intravenous administration of 10 mg/kg (which in separate studies produced an irinotecan C max and AUC about 3 and 0.5 times, respectively, the corresponding values in patie

Product summary:

Irinotecan hydrochloride injection, USP is available in single-dose amber glass vials in the following package sizes: 2 mL NDC 53104 0151 2 5 mL NDC 53104 0151 3 Store at 20° to 25°C (68° to 77°F). [See USP controlled room temperature.]. Protect from light. Keep the vial 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

IRINOTECAN HYDROCHLORIDE- IRINOTECAN HYDROCHLORIDE INJECTION
AREVA PHARMACEUTICALS,INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
IRINOTECAN HYDROCHLORIDE INJECTION,
USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
IRINOTECAN HYDROCHLORIDE INJECTION,
USP.
IRINOTECAN HYDROCHLORIDE INJECTION USP, INTRAVENOUS INFUSION
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 AND REDUCE SUBSEQUENT DOSES IF
SEVERE DIARRHEA OCCURS.
SEVERE MYELOSUPPRESSION MAY OCCUR.
RECENT MAJOR CHANGES
Warnings and Precautions, Myelosuppression (5.2) 02/2019
INDICATIONS AND USAGE
Irinotecan hydrochloride injection, USP 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 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 by 5-FU
intravenous bolus infusion on
days 1, 8, 15, 22 every 6 weeks. ( 2.1)
Colorectal cancer combination regimen 2: Irinotecan 180 mg/m
intravenous infusion over 90 minutes on days 1, 15,
29 with LV 200 mg/m
intravenous infusion over 2 hours on days 1, 2, 15, 16, 29, 30
followed by 5-FU 400 mg/m
intravenous b