CAMPTOSAR® Indications and Usage (irinotecan HCl) | Pfizer Medical Information - US

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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.
CAMPTOSAR is indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy.

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Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

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HIGHLIGHTS OF PRESCRIBING INFORMATION

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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

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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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 from...

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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 Dosage and Administration (2)...

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15 REFERENCES

"OSHA Hazardous Drugs." OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html

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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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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 labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.

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To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:

Pfizer Safety Reporting Site

*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.

If you cannot use the above website or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at
(800) 438-1985.

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You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
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