IRINOTECAN HYDROCHLORIDE- irinotecan hydrochloride injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Teva Parenteral Medicines, Inc.

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 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 Cmax and AUC about 3 and 0.5 times, respectively, the corresponding values in patients administered 125 mg/m2 ). Intravenous administration of irinotecan 6 mg/kg/day to rats and rabbits during the period of organogenesis resulted in increased post-implantation loss and decreased numbers of live fetuses. In separate studies in rats, this dose produced an irinotecan Cmax

Product summary:

Irinotecan hydrochloride injection is available in single-use vials in the following package sizes: NDC Number Strength Irinotecan Hydrochloride Injection 0703-4432-81 40 mg/2 mL Single use vial packaged individually 0703-4434-81 100 mg/5 mL Single use vial packaged individually Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light. Do not freeze. 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. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

IRINOTECAN HYDROCHLORIDE- IRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION
TEVA PARENTERAL MEDICINES, 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.
IRINOTECAN HYDROCHLORIDE INJECTION, 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 HYDROCHLORIDE INJECTION AND REDUCE
SUBSEQUENT DOSES IF SEVERE
DIARRHEA OCCURS.
SEVERE MYELOSUPPRESSION MAY OCCUR.
INDICATIONS AND USAGE
Irinotecan hydrochloride injection 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. (2.2)
Colorectal cancer single agent regimen 2: Irinotecan hydrochloride
injection 350 mg/m intravenous infusion over 90
minutes on day 1 every 3 weeks. (2.2)
DOSAGE FORMS AND STRENGTHS
Irinotecan hydrochloride injection is available in two single-use
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 hydrochloride injection or its
excipients (4)
WARNINGS AND PRECAUTIONS
DIARRHEA AND CHOLINER