IRINOTECAN HYDROCHLORIDE injection

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Armas Pharmaceuticals Inc.

Njia ya uendeshaji:

INTRAVENOUS

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

• 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 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 and AUC of

Bidhaa muhtasari:

Irinotecan hydrochloride injection, USP is available in single-dose amber colored vials in the following package sizes: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature ]. Protect from light. Protect from freezing, 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.

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

IRINOTECAN HYDROCHLORIDE- IRINOTECAN HYDROCHLORIDE INJECTION
ARMAS PHARMACEUTICALS 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, FOR 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.
RECENT MAJOR CHANGES
Warnings and Precautions, Myelosuppression (5.2) 02/2019
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, USP is available in three
single-dose sizes: (3)
2 mL-fill vial containing 40 mg Irinotecan hydrochloride injection,
USP
5 mL-fill vial containing 100 mg Irinotecan hydrochloride injection,
USP
15 mL-fill vial containing 300 mg Irinotecan