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.

Author: Tedal Dorisar
Country: Cameroon
Language: English (Spanish)
Genre: Business
Published (Last): 2 October 2009
Pages: 429
PDF File Size: 4.99 Mb
ePub File Size: 9.12 Mb
ISBN: 900-2-40542-454-1
Downloads: 77175
Price: Free* [*Free Regsitration Required]
Uploader: Fenrizragore

HIGHLIGHTS OF PRESCRIBING INFORMATION

Procedures for proper handling and disposal: However, serious opportunistic infections have not been observed, and no complications have specifically been attributed to lymphocytopenia. Patients in the control arm of the Study 8 received one of the following 5-FU regimens: Refrigeration of admixtures using 0. Pharmacokinetics in Special Populations Geriatric: The most clinically significant adverse events for patients receiving irinotecan-based therapy were diarrhea, nausea, vomiting, neutropenia, and alopecia.

Among these patients, 2 complete and 27 partial responses were observed, for an overall response rate of In Study 2, median survival for patients treated with irinotecan was A total inseet patients were randomized in the two studies at 94 centers. Tables 5 and 6 list the clinically relevant adverse events reported in Studies 1 and 2, respectively.

Camptosar Product Information

Two multicenter, randomized, clinical studies further support the use of irinotecan given pxckage the once-everyweek dosage schedule in patients with metastatic colorectal cancer whose disease has recurred or progressed following prior 5-FU therapy.

  ADAM DAN HAWA AISYA SOFEA NOVEL PDF

The plasma protein to which irinotecan and SN predominantly binds is albumin. Metabolism 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.

Neutropenic fever occurred in nine 3.

Dose Modifications Patients should be carefully monitored for toxicity and assessed prior to each treatment. 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. Dexamethasone, a moderate CYP3A4 inducer, does not appear to alter the pharmacokinetics of irinotecan.

In vitro cytotoxicity assays show that the potency of Padkage relative to irinotecan varies from 2- to fold. Patient characteristics and major efficacy results are shown in Table Omit dose until resolved to baseline, then 2 dose levels. Patients in these studies had a variety of tumor types, including cancer of the colon or rectum, and were treated with several different doses and schedules.

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. Study 5 was a multicenter study that enrolled patients from 30 institutions. Patients receiving irinotecan reported significantly better results for the global health status, on two of five functional subscales, and on four cam;tosar nine symptom subscales.

  CRAFTSMAN 88957 MANUAL PDF

This dosage regimen exceeds the usual dosage recommendations for loperamide. The plasma protein to which irinotecan and SN predominantly binds is albumin. Physicians should also consider providing patients with an antiemetic regimen e.

Camptosar® (Irinotecan) – GlobalRPH

Loperamide is not recommended to be used for more than 48 consecutive hours at these doses, because of the risk of paralytic ileus. Dose Modification Recommendations Table 8 describes the recommended dose modifications during a course of therapy with the weekly dosage schedule and at the start of each subsequent course of therapy with both the weekly or everyweek dosage schedules.

Other drugs should not be added to the infusion solution. Irinotecan and its active metabolite SN bind to the topoisomerase I-DNA complex and prevent religation of these single-strand breaks.

Treatment cqmptosar be delayed 1 to 2 weeks to allow for recovery from treatment-related toxicity. Disclaimer The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment.

The highest total dose permitted was mg. In the clinical studies testing the every 3-week-dosage schedule, the median time to the onset of late diarrhea was 5 days after irinotecan infusion.