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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Effect of Renal Impairment The influence of renal impairment on the pharmacokinetics of irinotecan has not been evaluated.
Camptosar Full Prescribing
Irinotecan can also oackage CYP3A4-mediated oxidative metabolism to several inactive oxidation products, one of which can be hydrolyzed by carboxylesterase to release SN Long-term carcinogenicity studies with irinotecan were not conducted. The recommended treatment regimen one course is once every 3 weeks. Irinotecan is subject to extensive metabolic cajptosar by various enzyme systems, including esterases to form the active metabolite SN, and UGT1A1 mediating glucuronidation of SN to form the inactive glucuronide metabolite SNG.
Studies 1 and 2 Two phase 3, randomized, controlled, multinational clinical trials support the use of CAMPTOSAR Injection as first-line treatment of patients with metastatic carcinoma of the colon or rectum.
Camptosar® (Irinotecan) – GlobalRPH
Patients camptosra be alerted to the possibility of alopecia. Best supportive care was provided to patients in both arms of Study 7 and included antibiotics, analgesics, corticosteroids, transfusions, psychotherapy, or any other symptomatic therapy as clinically indicated.
Keep the vial in the carton until the time of use.
The adverse event profile was different in this study from that observed in adults; the most significant grade 3 or 4 adverse events were dehydration experienced by 6 patients Avoid diuretics or laxatives in patients with diarrhea.
Data from three open-label, single-agent, inswrt studies, capmtosar 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. Am J Health-Syst Pharm.
If reconstitution and dilution are performed under strict aseptic conditions e. In Study 2, median survival for patients treated with irinotecan was Bradycardia may also occur, but has not required intervention. Multiple regression analyses determined that patients’ baseline characteristics also had oackage significant effect on survival.
The majority of responses were observed within the first two courses packge therapy, but responses did occur in later courses of treatment one response was observed after the eighth course. The answers from the 30 questions insret converted into 15 subscales, that were scored from 0 toand the global health status subscale that was derived from two questions about the patient’s sense of general well being in the past week.
Irinotecan was teratogenic in rats at doses greater than 1. In Japanese studies, a reticulonodular pattern on chest x-ray was observed in a small percentage of patients.
Late diarrhea generally occurring more than 24 hours after administration of CAMPTOSAR can be life threatening since it may be prolonged and may lead to dehydration, electrolyte imbalance, or sepsis. Each patient should be instructed to have loperamide readily available and to begin treatment for late diarrhea generally occurring more than 24 hours after administration of CAMPTOSAR at the first episode of poorly formed or loose stools or the earliest onset of bowel movements more frequent than normally expected for the patient.
In a phase 1 clinical study involving irinotecan, 5-fluorouracil 5-FUand leucovorin LV in 26 patients with solid tumors, the disposition of irinotecan was not substantially altered when the drugs were co-administered. These studies were designed to evaluate tumor response rate and do not provide information on effects on survival and disease-related symptoms. Its structural formula is as follows:.
Dose modifications for hematologic toxicities other than neutropenia e. Patients receiving irinotecan reported significantly better results for the global health status, on two of five functional subscales, and on four of nine symptom subscales. Results from two open-label, single arm studies were evaluated.
HIGHLIGHTS OF PRESCRIBING INFORMATION
No change in the starting dose is recommended for geriatric patients receiving the weekly dosage schedule of irinotecan [see Dosage and Administration 2 ]. Effect of Age The pharmacokinetics of irinotecan administered using the weekly schedule was camptpsar in a study of patients that was prospectively designed to investigate the effect of age on irinotecan toxicity. The adverse events in these patients were similar to those reported with the recommended dosage and regimen.
CAMPTOSAR is indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based camphosar.
All patients in these studies had metastatic colorectal cancer, and the majority had disease that recurred or progressed following a 5-FU-based regimen administered for metastatic disease. Maximum concentrations of the active metabolite SN are generally seen within 1 hour following the end of a minute infusion of irinotecan.
Because of the inclusion of patients with non-measurable disease, intent-to-treat response rates could not be assessed. Irinotecan hydrochloride was clinically investigated as CPT Pharmacokinetics in Special Populations Geriatric: