package [500/mm:pretx ) Delay dose until resolved to baseline, then give same dose Maintain dose level 2 (4 6 stools/day > pretx) Omit dose until resolved to baseline, then 1 dose level Maintain dose level 3 (7 9 stools/day > pretx) Omit dose until resolved to baseline, then 1 dose level 1 dose level 4 ( 10 stools/day > pretx) Omit dose until resolved to baseline, then 2 dose levels 2 dose levels Other nonhematologic toxicities 1 Maintain dose level Maintain dose level 2 Omit dose until resolved to grade 1, then 1 dose level Maintain dose level 3 Omit dose until resolved to grade 2, then 1 dose level 1 dose level 4 Omit dose until resolved to grade 2, then 2 dose levels 2 dose levels For mucositis/stomatitis decrease only 5-FU, not Camptosar For mucositis/stomatitis decrease only 5-FU, not Camptosar. Colorectal Single Agent Regimens 1 and 2 Administer Camptosar as a 90-minute intravenous infusion. The currently recommended regimens are shown in Table 3. A reduction in the starting dose by one dose level of Camptosar may be considered for patients with any of the following conditions: prior pelvic/abdominal radiotherapy, performance status of 2, or increased bilirubin levels. Dosing for patients with bilirubin >2 mg/dL cannot be recommended because there is insufficient information to recommend a dose in these patients. Table 3. Single-Agent Regimens of Camptosar and Dose Modifications * Subsequent doses may be adjusted as high as 150 mg/m 2 or to as low as 50 mg/m 2 in 25 to 50 mg/m 2 decrements depending upon individual patient tolerance. Provided intolerable toxicity does not develop, treatment with additional cycles may be continued indefinitely as long as patients continue to experience clinical benefit. Subsequent doses may be adjusted as low as 200 mg/m 2 in 50 mg/m 2 decrements depending upon individual patient tolerance. Regimen 1 (weekly) * 125 mg/m 2 intravenous infusion over 90 minutes, days 1,8,15,22 then 2-week rest Starting Dose and Modified Dose Levels (mg/m 2 ) Starting Dose Dose Level -1 Dose Level -2 125 100 75 Regimen 2 (every 3 weeks) 350 mg/m 2 intravenous infusion over 90 minutes, once every 3 weeks Starting Dose and Modified Dose Levels (mg/m 2 ) Starting Dose Dose Level -1 Dose Level -2 350 300 250 Dose Modifications Based on recommended dose-levels described in Table 3, Single-Agent Regimens of Camptosar and Dose Modifications, subsequent doses should be adjusted as suggested in Table 4, Recommended Dose Modifications for Single-Agent Schedules. All dose modifications should be based on the worst preceding toxicity. Table 4: Recommended Dose Modifications For Single-Agent Schedules * * All dose modifications should be based on the worst preceding toxicity National Cancer Institute Common Toxicity Criteria (version 1.0) Pretreatment Excludes alopecia, anorexia, asthenia A new cycle of therapy should not begin until the granulocyte count has recovered to 1500/mm 3 , and the platelet count has recovered to 100,000/mm 3 , and treatment-related diarrhea is fully resolved. Treatment should be delayed 1 to 2 weeks to allow for recovery from treatment-related toxicities. If the patient has not recovered after a 2-week delay, consideration should be given to discontinuing Camptosar. Worst Toxicity NCI Grade (Value) During a Cycle of Therapy At the Start of the Next Cycles of Therapy (After Adequate Recovery), Compared with the Starting Dose in the Previous Cycle * Weekly Weekly Once Every 3 Weeks No toxicity Maintain dose level 25 mg/m 2 up to a maximum dose of 150 mg/m 2 Maintain dose level Neutropenia 1 (1500 to 1999/mm 3 ) Maintain dose level Maintain dose level Maintain dose level 2 (1000 to 1499/mm 3 ) 25 mg/m 2 Maintain dose level Maintain dose level 3 (500 to 999/mm 3 ) Omit dose until resolved to grade 2, then 25 mg/m 2 25 mg/m 2 50 mg/m 2 4 (] FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only D Pregnancy Category Positive evidence of risk N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Manufacturer Pfizer Inc. Drug Class Miscellaneous antineoplastics Related Drugs miscellaneous antineoplastics tretinoin , Revlimid , Zytiga , Accutane , isotretinoin , irinotecan Colorectal Cancer Avastin , fluorouracil , Xeloda , capecitabine , Opdivo , leucovorin , Keytruda , nivolumab , oxaliplatin , bevacizumab , Erbitux , Betaseron , pembrolizumab , irinotecan , Stivarga , cetuximab , Lonsurf , Cyramza , Vectibix , regorafenib , Eloxatin , ramucirumab , levoleucovorin calcium , Fusilev , panitumumab , More... Camptosar Rating 1 User Review 5.0 /10 1 User Review 5.0 Rate it! to surround
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