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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Table 8 lists the grade 3 and 4 adverse events reported in the patients enrolled to all treatment arms of the two studies described in Clinical Studies Studies 3, 4, and 5 Data from three open-label, single-agent, clinical studies, involving 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 5-FU-based therapy.

Irinotecan is a camptozar of camptothecin. 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.

Several published guidelines for handling and disposal of anticancer agents are available. National Study Commission on Cytotoxic Exposure.

Rates were also similar in patients with cancer of the colon or cancer of the rectum and in patients with single and multiple metastatic sites. New or progressive, dyspnea, cough, and fever should prompt interruption of chemotherapy, pending diagnostic evaluation. Data from an open-label, single-agent, single arm, multicenter, clinical study involving a total of patients support a once everyweek dosage schedule of irinotecan in the treatment of patients with metastatic cancer of the colon or rectum that recurred or progressed following treatment with 5-FU.

The adverse events in these patients were similar to those reported with the recommended dosage and regimen. In Study 2, 10 3.

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HIGHLIGHTS OF PRESCRIBING INFORMATION

Interrupt for new or progressive dysnpnea, cough, and fever pending evaluation. First-line therapy in combination with 5-fluorouracil and leucovorin for patients with metastatic carcinoma of the colon or rectum. There are no adequate and well-controlled studies of irinotecan in pregnant women.

Single-agent dosage regimens are shown in Table In three clinical studies evaluating the weekly dosage schedule, patients with metastatic carcinoma of the colon or rectum that had recurred or progressed following 5-FU-based therapy were treated with CAMPTOSAR. This single agent therapy was followed by multimodal therapy. At the start of each cycle of therapy, patients completed a questionnaire consisting of 30 questions, such as “Did pain interfere with daily activities? The influence of race on the pharmacokinetics of irinotecan has not been evaluated.

Patients should contact their physician if any of the following occur: Rashes have also been reported but did not result in discontinuation of treatment. Routine administration of a colony-stimulating factor CSF is not necessary, but physicians may wish to consider CSF use in individual patients experiencing significant neutropenia. If the drug is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to the fetus.

Severe myelosuppression may occur. Hyponatremia, mostly with diarrhea and vomiting, has been reported. Controlling Occupational Exposure to Hazardous Drugs. Studies 1 and 2. It is recommended that patients receive premedication with antiemetic agents. Serious thrombocytopenia is uncommon.

Camptosar Full Prescribing

Irinotecan serves as a water-soluble precursor of the lipophilic metabolite SN The highest total dose permitted was mg. When comparing irinotecan with best supportive care in Study 7, this analysis showed camposar statistically significant advantage for irinotecan, with longer time to development of pain 6.

In rats, at exposures approximately 0. The pharmacokinetics of irinotecan do not appear to be influenced by gender. The use of gloves is recommended.

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If damaged, incinerate the unopened package. Under these conditions, there was a significant linear trend with dose for the incidence of combined uterine horn endometrial stromal polyps and endometrial stromal sarcomas. This product’s label may have been updated.

Irinotecan hydrochloride is a semisynthetic derivative of camptothecin, an alkaloid extract from plants such as Camptotheca acuminata or is chemically synthesized. Irinotecan hydrochloride is a semisynthetic derivative of camptothecin, an alkaloid extract from plants such as Camptotheca acuminata.

SN is formed from irinotecan by carboxylesterase-mediated cleavage of the carbamate bond between the camptothecin moiety and the dipiperidino side chain. The mean terminal elimination half-life of the active metabolite SN is about 10 to 20 hours.

However, the precise camltosar reduction in this patient population is not known, campgosar subsequent dose modifications should be considered based on individual patient tolerance to treatment see Tables 1—4.

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.

Begin loperamide at the first episode of poorly formed or loose stools or the earliest onset of bowel movements more frequent than normal. One dosage regimen for loperamide is 4 mg at the first onset of late diarrhea and then 2 mg every 2 hours until the patient is diarrhea-free for at least 12 hours. Consider prophylactic or therapeutic administration of 0. The results as summarized in Table 4 are based on patients’ worst post-baseline scores. Two multicenter, randomized, clinical studies further support the use of irinotecan given by the once-everyweek dosage camptosarr in patients with metastatic colorectal cancer whose ibsert has recurred or progressed famptosar prior 5-FU therapy.

Increases in serum levels of transaminases i.