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:

BluePoint Laboratories

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. 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

Product summary:

Irinotecan hydrochloride injection, USP is available in single-dose amber glass vials in the following package sizes: 40mg/2mL vial NDC 68001-284-35. 2mL vials are packed individually per shelf pack with NDC 68001-284-34. 100mg/5mL vial NDC 68001-284-22. 5mL vials are packed individually per shelf pack with NDC 68001-284-25. Store at 20°C to 25°C (68°F 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
BLUEPOINT LABORATORIES
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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_.
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RECENT MAJOR CHANGES
INDICATIONS AND USAGE
Irinotecan hydrochloride injection, USP is a topoisomerase inhibitor
indicated for:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Irinotecan hydrochloride injection, USP is available in two
single-dose sizes: (3)
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Common adverse reactions (>30%) observed in combination therapy
clinical studies are: nausea, vomiting, abdominal
pain, diarrhea, constipation, anorexia, mucositis, neutropenia,
leukopenia (including lymphocytopenia), anemia,
thrombocytopenia, asthenia, pain, fever, infection, abnormal
bilirubin, alopecia. (6.1)
Common adverse reactions (>30%) observed in single agent therapy
clinical studies are: nausea, vomiting, abdominal
pain, diarrhea, constipation, anorexia, neutropenia, leukopenia
(including lymphocytopenia), anemia, asthenia, fever, body
weight decreasing, alopecia. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT CIPLA LIMITED, INDIA AT
1-866-604-3268 OR FDA AT 1-
800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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USE IN SPECIFIC POPULATIONS
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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. INSTITUT