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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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: Studies Evaluating the Weekly Dosage Schedule Data from three open-label, single-agent, clinical studies, involving a total of patients in 59 centers, support the use of CAMPTOSAR in the insertt of patients with metastatic cancer of the colon or rectum that has recurred or progressed following treatment with fluorouracil 5-FU -based therapy.

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 camptosxr has recurred or progressed following treatment with fluorouracil 5-FU -based therapy.

Camptosar Full Prescribing

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.

In Study 2, the multivariate analysis on all 15 subscales did not indicate a statistically significant difference between irinotecan and infusional 5-FU.

In three clinical studies evaluating camptoxar weekly dosage schedule, patients with metastatic carcinoma of the colon or rectum insett had recurred or progressed following 5-FU-based therapy were treated with CAMPTOSAR. One hundred nineteen 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. Maximum concentrations of the active metabolite SN are generally seen within 1 hour following the end of a minute infusion of irinotecan.

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Patients in the control arm of the Study 8 received one of the following 5-FU regimens: Therefore, caution should be undertaken in patients with impaired renal function. Lymphocytopenia has been reported in patients receiving CAMPTOSAR, and it is possible that the administration of dexamethasone as antiemetic prophylaxis may have enhanced inserg likelihood of this effect.

Symptomatic pancreatitis, asymptomatic pancreatic enzyme elevation have been reported. The global health status subscale was derived from two questions about inssert patient’s sense of general well being in the past week.

However in clinical trials of the weekly dosage schedule, it has been noted that patients with modestly elevated baseline serum total bilirubin levels 1. Patients with baseline serum total bilirubin levels insdrt 1.

Current research suggests that the cytotoxicity of irinotecan is due to double-strand DNA damage produced during DNA synthesis when replication enzymes interact with the ternary complex formed by topoisomerase I, DNA, and either irinotecan or SN Current research suggests that the cytotoxicity of irinotecan is due to double-strand DNA damage produced during DNA synthesis when replication enzymes interact with the ternary complex formed by topoisomerase I, DNA, and either irinotecan hydrochloride or SN Treatment should be delayed 1 to 2 weeks to allow for recovery from treatment-related toxicities.

No change in the starting dose is recommended for geriatric patients receiving the weekly dosage schedule of irinotecan. ASHP guidelines on handling hazardous drugs. Pharmacokinetics in Special Populations Geriatric: Keep the vial in the carton until the time of use. Administration of irinotecan has resulted in antitumor activity in mice bearing cancers of rodent origin and in human carcinoma xenografts of various histological types. In vitro cytotoxicity assays show that the potency of SN relative to irinotecan varies from 2- to fold.

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The adverse events in Table 7 are based on the experience of the patients enrolled in the three studies described in Clinical Studies Its structural formula is as follows:.

HIGHLIGHTS OF PRESCRIBING INFORMATION

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 and its active metabolite SN bind to the topoisomerase I-DNA camptosra and prevent religation of these single-strand breaks.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The influence of hepatic inxert on the pharmacokinetic characteristics of irinotecan and its metabolites has not been formally studied.

Camptosar® (Irinotecan) – GlobalRPH

The adverse events in these patients were similar to those reported with the recommended dosage and regimen. Serious thrombocytopenia is uncommon. Patient characteristics and major efficacy results are shown in Table The use of drugs with laxative properties should be avoided because of the potential for exacerbation of diarrhea. Am J Hosp Pharm ; Subsequent packaage chemotherapy treatments should be delayed in patients until return of pretreatment bowel function for at least 24 hours without anti-diarrhea medication.

It is not known whether this drug is excreted in human milk. In Study 8, second-line irinotecan therapy was compared with infusional 5-FU-based therapy. Manage promptly with antibiotic support.

A pH-dependent equilibrium exists between the two forms such that an insery pH promotes the formation of the lactone, while a more basic pH favors the hydroxy acid anion form.