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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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Neither irinotecan nor its active metabolite SN was mutagenic in the in vitro Ames assay. Patients were to be followed every 3 to 6 weeks for 1 year. Drug Interactions Dexamethasone, a moderate CYP3A4 inducer, does not appear to alter the pharmacokinetics of irinotecan. It is slightly soluble in water and organic solvents. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available.

A laboratory test is available to determine the UGT1A1 status of patients. Omit dose until resolved to baseline, then 2 dose levels. Both irinotecan and SN exist in an active pcakage form and an inactive hydroxy acid anion form. Long-term carcinogenicity studies with irinotecan were not conducted.

Camptosar Full Prescribing

Grade 3—4 neutropenia was experienced by 54 The mean terminal elimination half-life of the active metabolite SN is about 10 to acmptosar hours. Patients should be alerted to the possibility of alopecia.

The currently recommended regimens are inserg in Table 1. 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. Best supportive care was provided to patients in both arms of Study 7 and included antibiotics, analgesics, corticosteroids, transfusions, psychotherapy, or any other jnsert therapy as clinically indicated.

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Irinotecan hydrochloride is a semisynthetic derivative of insedt, an alkaloid inseert from plants such as Camptotheca acuminata or is chemically synthesized. The half-lives of the lactone active forms of irinotecan and SN are similar to those of total irinotecan and SN, as the lactone and hydroxy acid forms are in equilibrium. Risk factors include pre-existing lung disease, use of pneumotoxic drugs, radiation therapy, and colony stimulating factors.

SN is approximately times as potent as irinotecan as an inhibitor of topoisomerase I purified from human and rodent tumor cell lines. Late diarrhea generally occurring more than 24 hours after administration of CAMPTOSAR can be prolonged, may lead to dehydration and electrolyte imbalance, and can be life threatening. The recommended treatment regimen one course is once every 3 weeks.

HIGHLIGHTS OF PRESCRIBING INFORMATION

Patients and patients’ caregivers should be informed of the expected toxic effects of CAMPTOSAR, particularly of its gastrointestinal manifestations, such as nausea, vomiting, and diarrhea. Other drugs should not be added to the infusion solution.

In separate studies in rats, this dose produced an irinotecan C max and AUC of about 2 and 0. First-line therapy in combination with 5-fluorouracil and leucovorin for patients with metastatic carcinoma of the colon or rectum.

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. Pharmacokinetics After intravenous infusion of irinotecan in humans, irinotecan plasma concentrations decline in a multiexponential manner, with a mean terminal elimination half-life of about 6 to 12 hours.

Recommendations for handling camptossar agents. 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.

Effect of Camptossar 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.

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Care should be taken to avoid extravasation, and the infusion site should be monitored for signs of inflammation. Neutropenic fever, defined as NCI grade 4 neutropenia and grade 2 or greater fever, occurred in nine 3. This single agent therapy was followed by multimodal therapy. Guidelines and recommendations for safe handling of antineoplastic captosar. In clinical trials of the weekly dosage schedule, patients with modestly elevated baseline serum total bilirubin levels 1.

Irinotecan was clastogenic both in vitro chromosome aberrations in Chinese hamster ovary cells and in vivo micronucleus test in mice. Dose modifications for leukopenia, thrombocytopenia, and anemia during a cycle of therapy and at the start of subsequent cycles of therapy are also based on NCI toxicity criteria and are the same as recommended packaye neutropenia above.

Cases of megacolon and intestinal perforation have been reported. 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.

Should extravasation occur, flushing the site with sterile water and applications of ice are recommended. 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: A new cycle of therapy should not camtposar until the toxicity has recovered to NCI grade 1 or less.

Use caution and do not use in patients on dialysis.

Am J Hosp Pharm ; In vitro cytotoxicity assays show that the potency of SN relative to irinotecan varies from 2- to fold. The use of gloves is recommended.