CAMPTOSAR PACKAGE INSERT PDF

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.

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Procedures for proper handling and disposal: With the weekly dosage schedule, patients with total bilirubin levels 1. These studies were designed to evaluate tumor response rate and do not provide information on effects on survival and disease-related symptoms. The answers from the 30 questions were converted into 15 subscales, that were scored from 0 to The influence of renal impairment on the pharmacokinetics of irinotecan has not been evaluated. Omit dose until resolved, then 2 dose levels.

OSHA work-practice guidelines for personnel dealing with cytotoxic antineoplastic drugs. Bradycardia may also occur. Long-term carcinogenicity studies with irinotecan were not conducted.

Both irinotecan and SN exist in an active lactone form and an inactive hydroxy acid anion form. It is slightly soluble in water and organic solvents.

If these symptoms occur, they manifest during or shortly after drug infusion. In Study 2, a 7-day course of fluoroquinolone antibiotic prophylaxis was given in patients whose diarrhea persisted for greater than 24 hours despite loperamide or if they developed a fever in addition to diarrhea. In Study 8, median survival for patients treated with irinotecan was The influence of renal insufficiency on the pharmacokinetics of irinotecan has not been evaluated.

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The adverse effects of CAMPTOSAR, such as myelosuppression and diarrhea, would be camptosarr to be exacerbated by other antineoplastic agents having similar adverse effects. Pregnancy Category D [see Warnings and Precautions 5.

Camptosar Full Prescribing

Therefore, caution should be undertaken in patients with packafe renal function. If the patient has not recovered, consideration should be given to discontinuing therapy. Therefore, use caution in patients with impaired renal function. Effect of Race The influence of race on the pharmacokinetics of irinotecan has not been evaluated.

Tables 5 and 6 list the clinically relevant adverse events reported in Studies 1 and 2, respectively. Disclaimer The authors make no claims of the accuracy of the information contained herein; and these suggested doses are camtosar a substitute for clinical judgment.

The pH of the solution has been adjusted to 3.

HIGHLIGHTS OF PRESCRIBING INFORMATION

Information regarding the pharmacokinetics of irinotecan is not available. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, it is recommended that nursing be discontinued when receiving therapy with CAMPTOSAR. Irinotecan was teratogenic in rats at doses greater than 1.

Irinotecan can also undergo CYP3A4-mediated oxidative metabolism to several inactive oxidation products, one of which can be hydrolyzed by carboxylesterase to release SN There is some information from Japanese trials that patients with considerable ascites or pleural effusions were at increased risk for neutropenia or diarrhea.

Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available. camposar

Because clinical trials are conducted under widely cakptosar conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

In studies using the weekly schedule, the terminal half-life of irinotecan was 6. A pH-dependent equilibrium exists between the two forms such that an acid pH promotes the formation of the lactone, while a more basic pH favors the hydroxy acid anion form.

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One of the patients died of neutropenic sepsis without fever. After the first treatment, patients with active diarrhea should return to pre-treatment bowel function without requiring anti-diarrhea medications for at least inserh hours before the next chemotherapy administration.

In vitro cytotoxicity assays show that the potency of SN relative to irinotecan varies from 2- to fold.

Care should be taken to avoid extravasation, and the infusion site should be monitored for signs of inflammation. Irinotecan hydrochloride was clinically investigated as CPT The first treatment course is shown in Table 7. Early diarrhea occurring during or shortly after infusion of CAMPTOSAR may be accompanied by cholinergic symptoms of rhinitis, increased salivation, pacage, lacrimation, diaphoresis, flushing, and intestinal hyperperistalsis that can cause abdominal cramping.

Studies Evaluating the Weekly Dosage Schedule Data from three open-label, single-agent, clinical studies, involving a total of patients in 59 centers, support the use of CAMPTOSAR ihsert 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. National Study Commission on Cytotoxic Exposure. Provided intolerable toxicity does not develop, treatment with additional cycles of CAMPTOSAR may be continued indefinitely as long as patients continue to experience clinical benefit.

Discontinuations due to adverse events were reported for 17 7.