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CAMPTOSAR®(irinotecan HCl)

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CAMPTOSAR® Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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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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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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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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3 DOSAGE FORMS AND STRENGTHS

CAMPTOSAR Injection is available in three single-dose sizes:

  • 2 mL-fill vial containing 40 mg irinotecan hydrochloride
  • 5 mL-fill vial containing 100 mg irinotecan...
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4 CONTRAINDICATIONS

  • CAMPTOSAR Injection is contraindicated in patients with a known hypersensitivity to the drug or its excipients.
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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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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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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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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Based on findings...

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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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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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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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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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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

14.1 Metastatic Colorectal Cancer

...

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15 REFERENCES

  • NIOSH Alert: Preventing occupational exposures to antineoplastic and other hazardous drugs in healthcare settings. 2004. U.S. Department of Health and Human Services, Public Health Service, Centers for...
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16 HOW SUPPLIED/STORAGE AND HANDLING

CAMPTOSAR Injection is available in single-dose brown glass vials in the following package sizes:

...
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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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This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com.

...

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