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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Canptosar currently recommended regimens are shown in Table 1. All dose modifications should be based on the worst preceding toxicity. The currently recommended regimens are shown in Table 3.

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 Tables 1—4. It is recommended that patients receive premedication with antiemetic agents. In clinical studies of the weekly dosage schedule, the majority of patients received 10 mg of dexamethasone given in conjunction with another type of antiemetic agent, such as a 5-HT 3 blocker e.

Physicians should also consider providing patients with an antiemetic regimen e. Prophylactic or therapeutic administration of atropine should be considered in patients experiencing cholinergic symptoms. Inspect vial contents for particulate matter and discoloration and repeat inspection when drug product is withdrawn from vial into syringe.

Other drugs should not be added to the infusion solution. Ineert solution is physically and chemically stable for up to 24 campotsar at room temperature and inseet ambient fluorescent lighting. Refrigeration of admixtures using 0. If reconstitution and dilution are performed under strict aseptic conditions e.

The use of gloves is recommended.

Camptosar Full Prescribing

Several published guidelines for handling and disposal of anticancer agents are available. Care should be taken to avoid extravasation, and the infusion site should be monitored for signs of inflammation.

Should extravasation occur, flushing the site with sterile water and applications of ice are recommended. It may be accompanied by cholinergic symptoms of rhinitis, increased salivation, miosis, lacrimation, diaphoresis, flushing, and intestinal hyperperistalsis that can cause abdominal cramping. Bradycardia may also occur. Early diarrhea and other cholinergic symptoms may be prevented or treated.

Consider prophylactic or therapeutic administration of 0. These inert are expected to occur more frequently with higher irinotecan doses. 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. In the clinical studies, the median time to the onset of late diarrhea was capmtosar days with 3-week dosing and 11 days with weekly dosing.

Late diarrhea can be complicated by colitis, ulceration, bleeding, ileus, obstruction, and infection. Cases of megacolon and intestinal perforation have been reported. Patients should have loperamide readily available to begin treatment for late diarrhea.

Insrt loperamide at the first episode of poorly formed or loose stools or the earliest onset of bowel movements more frequent than normal. 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. Loperamide is not inserg to be used for more than 48 consecutive hours at these doses, because of the risk of paralytic ileus. During the night, the patient may take 4 mg of loperamide every 4 hours.

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Monitor and replace fluid and electrolytes. Use antibiotic support for ileus, fever, or severe neutropenia. Subsequent weekly chemotherapy treatments should be delayed in padkage until return of pretreatment bowel function for at least 24 hours without anti-diarrhea medication.

Manage febrile neutropenia promptly with antibiotic support [see Warnings and Precautions 5. Patients with baseline serum total bilirubin levels of 1.

Grade 4 neutropenia was observed in 1. Grade 4 neutropenia was observed in 6. 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 ].

A laboratory test is available to determine the UGT1A1 status of patients. Hypersensitivity reactions including severe anaphylactic or anaphylactoid reactions have been observed. Interstitial Pulmonary Disease IPD -like events, including fatalities, have occurred in patients receiving irinotecan in combination and as monotherapy.

Risk factors include pre-existing lung disease, use of pneumotoxic drugs, radiation therapy, and colony stimulating factors.

In Japanese studies, a reticulonodular pattern on chest x-ray was observed in a small percentage of knsert. New or progressive, dyspnea, cough, and fever should prompt interruption of chemotherapy, pending diagnostic evaluation.

In rats, at exposures approximately 0. There are no adequate and well-controlled studies of irinotecan in pregnant women.

If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. In clinical trials of the weekly dosage schedule, patients with modestly elevated baseline serum total bilirubin levels 1. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Serious opportunistic infections have not been observed, and no complications have specifically been attributed to lymphocytopenia.

Camptosar® (Irinotecan) – GlobalRPH

In Indert 1, 49 7. Deaths potentially related to treatment occurred in 2 0. Deaths from any cause within 60 days of first study treatment were reported for 15 6. Discontinuations due to adverse events were reported for 17 7.

In Study 2, 10 3. Deaths from any cause within 60 days of first study treatment were reported for 3 2. Discontinuations due to adverse events were reported for 9 6. The most clinically significant adverse events for patients receiving irinotecan-based therapy were diarrhea, nausea, vomiting, neutropenia, and alopecia.

Tables 5 and 6 list the clinically relevant adverse events reported camptoosar Studies 1 and 2, respectively. 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. One of the patients died of neutropenic sepsis without fever.

Neutropenic fever occurred in nine 3. One hundred nineteen The most common reasons for dose reduction were late diarrhea, neutropenia, and leukopenia.

HIGHLIGHTS OF PRESCRIBING INFORMATION

The adverse events in Table 7 are based on the experience of the patients enrolled in the three studies described in Clinical Studies 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: 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 The incidence of akathisia in clinical trials of the weekly dosage schedule was greater 8.

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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. Symptomatic pancreatitis, asymptomatic pancreatic enzyme elevation have been reported. Increases in serum levels of transaminases i.

Transient dysarthria has been reported in patients treated with CAMPTOSAR; in some cases, the event was attributed to the cholinergic syndrome observed during or shortly after infusion of irinotecan.

Irinotecan has anticholinesterase activity, which may prolong the neuromuscular blocking effects of suxamethonium and the neuromuscular blockade of non-depolarizing drugs may be antagonized.

In a phase 1 clinical study involving irinotecan, 5-fluorouracil 5-FUand leucovorin LV in 26 patients with solid tumors, the disposition of irinotecan was not substantially altered when the drugs were co-administered. Formal in vivo or in vitro drug interaction studies to evaluate the influence of irinotecan on the disposition of 5-FU and LV have not been conducted.

Exposure to irinotecan or its active metabolite SN is substantially reduced in adult and pediatric patients concomitantly receiving the CYP3A4 enzyme-inducing anticonvulsants phenytoin, phenobarbital, carbamazepine, or St. The appropriate starting dose for patients taking these or other strong inducers such as rifampin and rifabutin has not been defined.

Pregnancy Category D [see Warnings and Precautions 5. In separate studies in rats, this dose produced an irinotecan C max and AUC of about 2 and 0. Irinotecan was teratogenic in rats at doses greater than 1. Teratogenic effects included a variety of external, visceral, and skeletal abnormalities. Radioactivity appeared in rat milk within 5 minutes of intravenous administration of radiolabeled irinotecan and was concentrated up to fold at 4 hours after administration relative to plasma concentrations.

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from CAMPTOSAR, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

The effectiveness of irinotecan in pediatric patients has not been established. Results from two open-label, single arm studies were evaluated. Grade 3—4 neutropenia was experienced by 54 Neutropenia was complicated by fever in 15 8. Grade 3—4 diarrhea was observed packagf 35 This adverse event profile was comparable to that observed in adults. This single agent therapy was followed by multimodal therapy.

Accrual to the single agent irinotecan phase was halted due to the high rate The adverse event profile was different in this study from that observed in adults; the most significant grade ijsert or 4 adverse events were dehydration experienced by 6 patients Patients greater than 65 years of age should lnsert closely monitored because of a greater risk of early and late diarrhea in this population [see Clinical Pharmacology The influence of renal impairment on the pharmacokinetics of irinotecan has not been evaluated.

Therefore, use caution in patients with impaired renal function. Irinotecan clearance is diminished in patients with hepatic impairment while exposure insret the active metabolite SN is increased relative to that in patients with normal hepatic function.

The magnitude of these effects is proportional to the degree of liver impairment as measured by elevations in total bilirubin and transaminase concentrations.