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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Among these patients, 2 complete and 27 partial responses were observed, for an overall response rate of The use of drugs with laxative properties should be avoided because of the potential for exacerbation of diarrhea.
Omit dose until resolved to baseline, then 2 dose levels. Metabolism Irinotecan is subject to extensive metabolic conversion by various packagd systems, including esterases to form the active metabolite SN, and UGT1A1 mediating glucuronidation of SN to form the inactive glucuronide metabolite SNG.
Because many drugs are excreted in human milk and because of the potential for serious adverse reactions camptozar nursing infants, it is recommended that nursing be discontinued when receiving therapy with CAMPTOSAR.
Administration of irinotecan has resulted in antitumor activity in mice bearing cancers of rodent origin and in human carcinoma xenografts of various histological types.
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. Other drugs should not be added to the infusion solution. Patients in both studies also received treatment with intravenous antibiotics if they had persistent diarrhea or fever or if ileus developed.
As expected, patients receiving irinotecan noted significantly more diarrhea than those receiving best supportive care. Camptothecins interact specifically with the enzyme topoisomerase I, which relieves torsional strain in DNA by inducing reversible single-strand breaks. Care should be inzert to avoid extravasation, and the infusion site should be monitored for signs of inflammation. Physicians should also consider providing patients with an antiemetic regimen e.
The mean terminal elimination half-life of the active metabolite SN is about 10 to 20 hours. The vial should be inspected for damage and visible signs of leaks before removing from the carton. 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.
Patients should contact their physician if any of the following occur: 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 Because of the longer collection period, these values provide a more accurate reflection of the terminal elimination half-lives of irinotecan and SN Irinotecan has anticholinesterase activity, which may prolong the neuromuscular blocking effects of suxamethonium and the neuromuscular blockade of non-depolarizing drugs may be antagonized.
The incidence of akathisia in clinical trials of the weekly dosage schedule was greater 8. Discontinuations due to adverse events were reported for 9 6. Loperamide is not recommended to be used for more than 48 consecutive hours at these doses, because of the risk of paralytic ileus.
HIGHLIGHTS OF PRESCRIBING INFORMATION
No change in the starting dose is recommended for geriatric patients receiving the weekly dosage schedule of irinotecan. The subscale scores of each patient were collected at each visit until the patient dropped out of the study. Teratogenic effects included a variety of external, visceral, and skeletal abnormalities. 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: However, the precise dose reduction in this patient population is not known and subsequent dose modifications should be considered based on individual patient tolerance to treatment [see Dosage and Administration 2 ].
In the clinical studies, the median time to the onset of late diarrhea was 5 days with 3-week dosing and 11 days with weekly dosing. The disposition of irinotecan has not been fully elucidated in humans. Preventing occupational exposures to antineoplastic and other hazardous drugs in healthcare settings. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Manage promptly with antibiotic support. The highest total dose permitted was mg. If IPD diagnosed, discontinue and institute appropriate treatment as needed.
Irinotecan hydrochloride is a semisynthetic derivative of camptothecin, an alkaloid extract from plants such as Camptotheca acuminata.
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.
Pregnancy Category D [see Warnings and Precautions 5. It is recommended that patients receive premedication with antiemetic agents. The results as summarized in Table 4 are based on patients’ worst post-baseline scores. The answers from the 30 questions were converted into 15 subscales, that were scored from 0 to ASHP guidelines on handling hazardous drugs.
Camptosar Full Prescribing
The magnitude of these effects is proportional to the degree of liver impairment as measured by elevations in total bilirubin and transaminase concentrations. A total of insdrt were randomized in the two studies at 94 centers. Maximum concentrations of the active metabolite SN are generally seen within 1 hour following the end of a minute infusion of irinotecan.