CAMPTOSAR PACKAGE INSERT PDF

  • June 17, 2019

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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Maximum supportive care should be instituted to prevent dehydration due to diarrhea and to treat any infectious complications. It is available in two single-dose sizes: Patients receiving irinotecan reported significantly better results for the global health status, on two of five functional subscales, and on four of nine symptom subscales. In vitro studies indicate that irinotecan, SN and another metabolite aminopentane carboxylic acid APCdo not inhibit cytochrome P isozymes.

Patients should have loperamide readily available to begin treatment for late diarrhea.

Effect of Race The influence of race on the pharmacokinetics of irinotecan has not been evaluated. Premedication with loperamide is not recommended. This dosage regimen exceeds the usual dosage recommendations for loperamide. SN is formed from irinotecan by carboxylesterase-mediated cleavage of the carbamate bond between the camptothecin moiety and the dipiperidino side chain.

Provided intolerable toxicity does not develop, treatment with additional courses of CAMPTOSAR may be continued indefinitely as long as patients continue to experience clinical benefit. Grade 3—4 diarrhea was observed in 35 All dose modifications should be based on the worst preceding toxicity. Symptomatic pancreatitis, asymptomatic pancreatic packag elevation have been reported. Patients should be alerted to the possibility of alopecia.

Early diarrhea and other cholinergic symptoms may be prevented or treated. If these symptoms occur, they manifest during or shortly after drug infusion.

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Camptosar® (Irinotecan) – GlobalRPH

After the first treatment, patients with active diarrhea should return to pre-treatment bowel function without requiring anti-diarrhea medications for at least 24 hours before the next chemotherapy administration. New or progressive, dyspnea, cough, and fever should prompt interruption of chemotherapy, pending diagnostic evaluation. Each patient should be instructed to have loperamide readily available and to begin treatment for late diarrhea generally occurring more than 24 hours after administration of CAMPTOSAR at the first episode of poorly formed or pakcage stools or the earliest onset of bowel movements more frequent than normally expected for the patient.

Risk factors include pre-existing lung disease, use of pneumotoxic drugs, radiation therapy, and colony stimulating factors. Omit dose until resolved to baseline, then 1 dose level.

It is slightly soluble in water and organic solvents. An association between baseline bilirubin elevations and an increased padkage of late diarrhea has not been observed in studies of the weekly dosage schedule. SN is approximately times as potent as irinotecan as ;ackage inhibitor of topoisomerase I purified from human and rodent cam;tosar cell lines.

Serious opportunistic infections have not camptossr observed, and no complications have specifically been attributed to lymphocytopenia. In Study 7, second-line irinotecan therapy plus best supportive care was compared with best supportive care alone. The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment.

HIGHLIGHTS OF PRESCRIBING INFORMATION

The pharmacokinetics of irinotecan do not appear to be influenced by gender. 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: 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 If czmptosar patient has not recovered after a 2-week delay, consideration should be given to discontinuing therapy.

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Multiple regression analyses determined that patients’ baseline characteristics also had a significant effect on survival. Both irinotecan and SN exist in an active lactone form and an inactive hydroxy acid anion form.

Dose modifications for hematologic toxicities other than neutropenia e. 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. Irinotecan has been studied in clinical trials in combination with packag 5-FU and leucovorin LV and as a single agent [see Dosage and Administration 2 ].

Late diarrhea generally occurring more than 24 hours after administration of CAMPTOSAR can be life threatening since it may be prolonged and may lead to dehydration, electrolyte imbalance, or sepsis. Accrual to the single agent irinotecan phase was halted due to the high rate 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. The most common reasons for dose reduction were late diarrhea, neutropenia, and leukopenia.

In Study 2, 10 3. Patients were to be followed every 3 to 6 weeks for 1 year. One of these paciage died of neutropenic sepsis without fever. Pharmacokinetics in Special Populations Geriatric: Safe handling of chemotherapeutic agents: Preventing occupational exposures to antineoplastic and other hazardous drugs in healthcare settings.