Irinotecan hydrochloride 20 mg/ml concentrate for solution for infusion capecitabine, please make sure that you also read the package insert for these. CATALOG SHEET · PACKAGE INSERT · SDS SHEET · BAR CODES · WHOLESALER ITEM NUMBERS · STORAGE REQUIREMENTS · RETURN GOODS. In depth information on Camptosar (irinotecan) for treatment of colorectal cancer. spacer. Camptosar (irinotecan) Product Information For Health Care Professionals CAMPTOSAR – Package Insert.

Author: Gorr Sall
Country: Cameroon
Language: English (Spanish)
Genre: Art
Published (Last): 7 March 2014
Pages: 201
PDF File Size: 10.65 Mb
ePub File Size: 7.42 Mb
ISBN: 948-3-23849-506-3
Downloads: 85487
Price: Free* [*Free Regsitration Required]
Uploader: Tojabar

Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from CAMPTOSAR, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

The disposition of irinotecan has not been fully elucidated in humans. Omit dose until resolved, then 2 dose levels. Teratogenic effects included a variety of external, visceral, and skeletal abnormalities.

Camptosar Full Prescribing

During the night, the patient may take 4 mg of loperamide every 4 hours. In Study 1, a multivariate analysis and univariate analyses of the individual subscales were performed and corrected for multivariate testing. Patients were to be followed every 3 ;ackage 6 weeks for 1 year.

Bradycardia may also occur. These studies were designed to evaluate tumor response rate and do not provide information on actual clinical benefit, such as effects on survival and disease-related symptoms.


Dose Inaert Patients should be carefully monitored for toxicity and assessed prior to each treatment. When necessary, pH has been adjusted to 3.

Physicians should also consider providing patients with an antiemetic regimen lnsert. Data from three open-label, single-agent, clinical studies, involving a total of patients in 59 centers, support the use of CAMPTOSAR in the treatment of patients with metastatic cancer of the colon or rectum that has recurred or progressed following treatment with fluorouracil 5-FU -based therapy.

However in clinical trials of the weekly dosage schedule, it has been noted that patients with modestly elevated baseline serum total bilirubin levels 1.

This product’s label may have been updated.

Camptosar Product Information

Irinotecan hydrochloride was clinically investigated as CPT Study 3 enrolled 48 patients and was conducted by a single investigator at several regional hospitals. In Study 1, median survival for patients treated with irinotecan was 9.

Am J Health-Syst Pharm. Once-EveryWeek Dosage Schedule A total of patients with metastatic colorectal cancer whose disease had recurred or progressed following prior 5-FU therapy participated in the two phase 3 studies: This adverse event profile was pavkage to that observed in adults.

Care of Intravenous Site: Its structural formula is as follows: If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. The contribution of irinotecan to these preliminary events was difficult to assess because these patients also had lung tumors and some had preexisting pac,age pulmonary disease.


Teratogenic effects included a variety of external, visceral, and skeletal abnormalities. The subscale scores of each patient were collected at each visit until the patient dropped out of the study.

All patients in these studies had inseft colorectal cancer, and the majority had disease that recurred or progressed following a 5-FU-based regimen administered for metastatic disease. Current research suggests that the cytotoxicity of irinotecan is due to double-strand DNA damage produced during DNA synthesis when replication enzymes interact with the ternary complex formed by topoisomerase I, DNA, and either irinotecan or SN Asthenia, camotosar, and abdominal pain are generally the most common events of this type.


Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Controlling Occupational Exposure to Hazardous Drugs.

Thereafter, additional courses of treatment may be repeated every 6 weeks 4 weeks on therapy, followed by 2 weeks rest. Provided intolerable toxicity does not develop, treatment with additional cycles may be continued indefinitely as long as patients continue to experience clinical benefit.

In Study 7, median survival for patients treated with irinotecan was 9.