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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In Study 8, median survival for patients treated with irinotecan was Am J Health-Syst Pharm. Pregnancy Category D [see Warnings and Precautions 5. The use of gloves is recommended. The magnitude of these ihsert is proportional to the degree of liver impairment as measured by elevations in total bilirubin and transaminase concentrations.

Irinotecan was clastogenic both in vitro chromosome aberrations in Chinese hamster ovary cells and in vivo micronucleus test in mice. Irinotecan hydrochloride is a semisynthetic derivative of camptothecin, an alkaloid extract from plants such as Camptotheca acuminata or is chemically synthesized. Irinotecan is a derivative of camptothecin.

If reconstitution and dilution are performed under strict aseptic conditions e. It is slightly soluble in water and organic solvents.

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Camptosar® (Irinotecan) – GlobalRPH

Camptothecins interact specifically with the enzyme topoisomerase I which relieves torsional strain in DNA by inducing reversible single-strand breaks. In Study 2, median survival for patients treated with irinotecan was One of the patients died of neutropenic sepsis without fever.

Irinotecan hydrochloride camptpsar clinically investigated as CPT Neither irinotecan nor its active metabolite SN was mutagenic in the in vitro Ames assay. There have been xamptosar of overdosage at doses up to approximately twice the recommended therapeutic dose, which may be fatal.

Information regarding the pharmacokinetics of irinotecan is not available. Study 5 was a multicenter study that enrolled patients from 30 institutions. Grade 3—4 neutropenia was experienced by 54 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studies: Inspect vial contents for particulate matter packagee discoloration and repeat inspection when drug product is withdrawn from vial into syringe.

Irinotecan serves as a water-soluble precursor of the lipophilic metabolite SN Manage febrile neutropenia promptly with antibiotic support [see Warnings and Precautions 5. Cases of megacolon and intestinal perforation have been reported.

HIGHLIGHTS OF PRESCRIBING INFORMATION

A potentially life threatening pulmonary syndrome, consisting of dyspnea, fever, and a reticulonodular pattern on chest x-ray, insrt observed in a small percentage of patients in early Japanese studies. The effectiveness of irinotecan in pediatric patients has not been established. In these same studies, patients with baseline serum total bilirubin levels of 1.

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These studies ineert designed to evaluate tumor response rate and do not provide information on effects on survival and disease-related symptoms. Explain the significance of routine blood cell counts.

Camptosar Full Prescribing

As expected, patients receiving irinotecan noted significantly more diarrhea than those receiving best supportive care. All dose modifications should be based on the worst preceding toxicity. Care should be taken to avoid extravasation, and the infusion site should be monitored for signs of inflammation.

Thereafter, additional courses of treatment may be repeated every 6 weeks 4 weeks on therapy, followed by 2 weeks rest. The most clinically significant adverse events for patients receiving irinotecan-based therapy were diarrhea, nausea, vomiting, neutropenia, and alopecia.

When comparing irinotecan with best supportive care in Study 7, this analysis showed a statistically significant advantage for irinotecan, with camptosqr time to development camptosr pain 6.