HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the... |
Did you find an answer to your question?
Yes
No
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our medical information is accurate, up to date, and scientifically balanced.
CAMPTOSAR®(irinotecan HCl)
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our medical information is accurate, up to date, and scientifically balanced.
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...
Did you find an answer to your question?
Yes
No
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.
- ...
Did you find an answer to your question?
Yes
No
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...
Did you find an answer to your question?
Yes
No
Dosage Forms and Strengths
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...
Did you find an answer to your question?
Yes
No
Contraindications
4 CONTRAINDICATIONS
- CAMPTOSAR Injection is contraindicated in patients with a known hypersensitivity to the drug or its excipients.
Did you find an answer to your question?
Yes
No
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...
Did you find an answer to your question?
Yes
No
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...
Did you find an answer to your question?
Yes
No
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...
Did you find an answer to your question?
Yes
No
Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Based on findings...
Did you find an answer to your question?
Yes
No
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...
Did you find an answer to your question?
Yes
No
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...
Did you find an answer to your question?
Yes
No
Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Irinotecan is a derivative of camptothecin. Camptothecins interact specifically with the enzyme topoisomerase I,...
Did you find an answer to your question?
Yes
No
Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term carcinogenicity studies with irinotecan were not conducted. Rats were...
Did you find an answer to your question?
Yes
No
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 14.1 Metastatic Colorectal Cancer
...
Did you find an answer to your question?
Yes
No
References
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...
Did you find an answer to your question?
Yes
No
How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
CAMPTOSAR Injection is available in single-dose brown glass vials in the following package sizes:
Did you find an answer to your question?
Yes
No
Patient Counseling Information
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...
Did you find an answer to your question?
Yes
No
Did you find an answer to your question?
Yes
No
Didn’t find what you were looking for? Contact us.
To interact with the Medical Information Digital Assistant click here.
Contact Pfizer Medical Information to speak with a professional regarding your medical question on a Pfizer prescription product: (800) 438-1985
Report Adverse Event
To report an adverse event related to the Pfizer-BioNTech COVID-19 Vaccine, and you are not part of a clinical trial* for this product, click the link below to submit your information:
*If you are involved in a clinical trial for this 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.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns at 1-800-FDA-1088 or www.fda.gov/MedWatch