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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Consider prophylactic or therapeutic administration of 0.

Prophylactic or therapeutic administration of 0. 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: Metabolism Irinotecan is subject to extensive metabolic conversion by various enzyme systems, including esterases to form the active metabolite SN, and UGT1A1 mediating glucuronidation of SN to form the inactive glucuronide metabolite SNG.

Early and late forms of diarrhea can occur. When necessary, pH has been adjusted to 3. Discontinuations due to adverse events were reported for 17 7. Use antibiotic support for ileus and fever.

Its structural formula is as follows: Two multicenter, randomized, clinical studies further support the use of irinotecan given by the once-everyweek dosage schedule in patients with metastatic colorectal cancer whose disease packahe recurred or progressed following prior 5-FU therapy. Deaths potentially related to treatment occurred in 2 0.

Patients with a performance status of 3 or 4 have not been studied. The highest total dose permitted was mg. Provided intolerable toxicity does not develop, treatment and additional courses of CAMPTOSAR may be continued indefinitely as long as patients continue to experience clinical benefit.

HIGHLIGHTS OF PRESCRIBING INFORMATION

A total of patients were randomized pcakage the two studies at 94 centers in Europe, the Middle East, and South Africa. Safe handling of chemotherapeutic agents: Grade 4 neutropenia campyosar observed in 6. Single-Agent Dosage Schedules ——————————. Best supportive care was provided to patients in both arms of Study 1 and included antibiotics, analgesics, corticosteroids, transfusions, psychotherapy, or any other symptomatic therapy as clinically indicated.

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For current full prescribing information, please visit www. One dosage regimen for loperamide used in clinical trials consisted of the following Note: It is recommended that patients receive premedication with antiemetic agents. ASHP insedt on handling hazardous drugs. The disposition of irinotecan has not been fully elucidated in humans. Its structural formula is as follows:. Loperamide is not recommended to be used for more than 48 consecutive hours at these doses, because of the risk of paralytic ileus.

In Insdrt 2, median survival for patients treated with irinotecan inwert In each study, CAMPTOSAR was administered in repeated 6-week courses consisting of a minute intravenous infusion once weekly for 4 weeks, paackage by a 2-week rest period.

Late diarrhea should be treated promptly with inseet patients with severe diarrhea should be carefully monitored and given fluid and electrolyte replacement if they become dehydrated see WARNINGS section.

SN is formed from irinotecan by carboxylesterase-mediated cleavage of the carbamate bond between the camptothecin moiety and the dipiperidino side chain. Irinotecan and its active metabolite SN bind to the topoisomerase I-DNA complex and prevent religation of these single-strand breaks. Dose modifications for leukopenia or thrombocytopenia 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 for neutropenia above.

Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available. 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.

Severe myelosuppression may occur. Effect of Gender The pharmacokinetics of irinotecan do not appear to be influenced by gender. When necessary, pH has been adjusted to 3. Use caution and do not use in patients on dialysis. The plasma protein to which irinotecan and SN predominantly binds is albumin.

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SN is approximately times as potent camptoar irinotecan as an inhibitor of paclage I purified from human and rodent tumor cell lines. Interrupt for new or progressive dysnpnea, cough, and fever pending evaluation.

The results as summarized in Table 13 are based on patients’ worst post-baseline scores.

Camptosar Full Prescribing

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

Symptomatic pancreatitis, asymptomatic pancreatic enzyme elevation have been reported. Maximum concentrations of the active metabolite SN are generally seen within 1 hour following the end of a minute infusion of irinotecan.

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.

Refrigeration of admixtures using 0. Packaye half the patients with dyspnea had lung metastases; the extent to which malignant pulmonary involvement or other preexisting lung disease may have contributed to dyspnea in these patients is unknown.

Mammalian cells cannot efficiently repair these double-strand breaks.

The adverse events in these patients were similar to camptosxr reported with the recommended dosage and regimen. A pH-dependent equilibrium exists between the two forms such that an acid pH promotes the formation of the lactone, while a more basic pH favors the hydroxy acid anion form.