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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These symptoms are packae to occur more frequently with higher irinotecan doses. The majority of responses were observed within the first two courses of therapy, but responses did occur in later courses of treatment one response was observed after the eighth course.

Monitor patients with diarrhea and give fluid and electrolytes as needed. As expected, patients receiving irinotecan noted significantly more diarrhea than those receiving best supportive care.

Interstitial Pulmonary Disease IPD -like events, including fatalities, have occurred in patients receiving irinotecan in combination and as monotherapy. Patients with a performance status of 3 or 4 have not been studied.

Several published guidelines for handling and disposal of anticancer agents are available.

Each patient should be instructed to have loperamide readily available and to begin treatment for late diarrhea generally occurring more than 24 hours after camptisar 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.

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There are no adequate and well-controlled studies of irinotecan in pregnant women.

HIGHLIGHTS OF PRESCRIBING INFORMATION

Effect of Age The pharmacokinetics of irinotecan administered using the weekly schedule was evaluated in a study of patients that was prospectively designed to investigate the effect of age on irinotecan toxicity. Patients should be alerted to the possibility of alopecia.

The influence of hepatic insufficiency on the pharmacokinetic characteristics of irinotecan and its metabolites has not been formally studied. The incidence of akathisia in clinical trials of the weekly dosage schedule was greater 8.

Accrual to the single agent irinotecan phase was halted due to the high rate Irinotecan serves as a water-soluble precursor of the lipophilic metabolite SN Because of the inclusion of patients with non-measurable disease, intent-to-treat response rates could not be assessed. Patients in the control arm of the Study 8 received one of the following 5-FU regimens: Patients were to be followed every 3 to 6 weeks for 1 year. Both irinotecan and SN exist in an active lactone form and an inactive hydroxy acid anion form.

Early diarrhea occurring during or shortly after infusion of CAMPTOSAR may be accompanied by cholinergic symptoms of rhinitis, increased salivation, miosis, lacrimation, diaphoresis, flushing, and intestinal hyperperistalsis that can cause abdominal cramping. Irinotecan was clastogenic both in vitro chromosome aberrations in Chinese hamster ovary cells and in vivo micronucleus test in mice.

Camptosar Product Information

It may be accompanied by symptoms of rhinitis, increased salivation, miosis, lacrimation, diaphoresis, flushing, and intestinal hyperperistalsis that can cause abdominal cramping.

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Irinotecan is subject to extensive metabolic conversion 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. In Japanese studies, a reticulonodular pattern on chest x-ray was observed in a small percentage of patients.

New or progressive, dyspnea, cough, and fever should prompt interruption of chemotherapy, pending diagnostic evaluation. The pH of the solution has been adjusted to 3. In Study 7, a multivariate analysis and univariate analyses of the individual subscales were performed and corrected for multivariate testing.

Manage promptly with antibiotic support. 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: Irinotecan serves as a water-soluble precursor of the lipophilic metabolite SN 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.

In Study 2, 10 campptosar. 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: Chemotherapy and biotherapy guidelines and recommendations for practice 2nd. Should extravasation occur, flushing the site with sterile water and applications of ice are recommended.