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CAMPTOSAR®(irinotecan HCl)
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CAMPTOSAR® Quick Finder
Highlights
Boxed Warning
WARNING: DIARRHEA and MYELOSUPPRESSION
- 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...
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Indications and Usage
1 INDICATIONS AND USAGE
- CAMPTOSAR 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.
- ...
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 Colorectal Cancer Combination Regimens 1 and 2
Administer CAMPTOSAR as a 90-minute intravenous infusion followed by LV and 5-FU. The...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
Injection: 40 mg/2 mL (20 mg/mL), 100 mg/5 mL (20 mg/mL), and 300 mg/15 mL (20 mg/mL) sterile, pale yellow, clear, aqueous solution in a single-dose vial.
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Contraindications
4 CONTRAINDICATIONS
- CAMPTOSAR Injection is contraindicated in patients with a known hypersensitivity to the drug or its excipients.
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Diarrhea and Cholinergic Reactions
Early diarrhea (occurring during or shortly after infusion of CAMPTOSAR) is usually transient and...
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Adverse Reactions
6 ADVERSE REACTIONS
6.1 Clinical Studies Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the...
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Drug Interactions
7 DRUG INTERACTIONS
7.1 5-Fluorouracil (5-FU) and Leucovorin (LV)
In a phase 1 clinical study involving irinotecan, 5-fluorouracil (5-FU), and leucovorin (LV) in 26...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Based on findings from...
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Overdosage
10 OVERDOSAGE
In U.S. phase 1 trials, single doses of up to 345 mg/m2 of irinotecan were administered to patients with various cancers. Single doses of up to 750 mg/m2 of...
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Description
11 DESCRIPTION
CAMPTOSAR Injection (irinotecan hydrochloride injection) is an antineoplastic agent of the topoisomerase I inhibitor class.
CAMPTOSAR is supplied as a sterile, pale yellow, clear, aqueous solution. Each...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Irinotecan is a derivative of camptothecin. Camptothecins interact specifically with the enzyme topoisomerase I,...
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term carcinogenicity studies with irinotecan were not conducted. Rats were,...
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Clinical Studies
14 CLINICAL STUDIES
Irinotecan has been studied in clinical trials in combination with 5-fluorouracil (5-FU) and leucovorin (LV) and as a single agent [see Dosage and Administration (2)...
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References
15 REFERENCES
- "OSHA Hazardous Drugs." OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
CAMPTOSAR (irinotecan hydrochloride) Injection is available as a sterile, pale yellow, clear, aqueous solution in a vial packaged within a carton in the following packaging configurations...
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Medication Guide
17 PATIENT COUNSELING INFORMATION
- Patients and caregivers should be informed of gastrointestinal complications, such as nausea, vomiting, abdominal cramping, and diarrhea. Patients should have loperamide readily...
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