The information on dosage adjustments in renal impairment given in this book is based on. Optimising the dose of capecitabine in metastatic breast cancer. The renal drug handbook the st georges hospital, adult critical. Xeloda capecitabine is a fluoropyrimidine carbamate with antineoplastic activity. Phase 2 trial of a novel capecitabine dosing schedule in. Follow your doctors dosing instructions very carefully. Renal impairment has no effect on the pharmacokinetics of capecitabine or 5fu, but leads to an. A phase i study in rectal cancer defined the recommended dose of capecitabine to be 825 mgm2 b. Xeloda capecitabine dosing, indications, interactions, adverse. Trivalent forms of arsenic are methylated in humans and mostly excreted in urine. Capecitabine is a prodrug of 5fu selective tumor activation by thymidine phosphorylase used for the. Capecitabine in the treatment of metastatic renal cell. If your institution subscribes to this resource, and you dont have a myaccess profile, please contact your librarys reference desk for information on how to gain access to this resource. Guidelines for chemotherapy dosage adjustment hematology.
Abstract optimizing chemotherapeutic doseschedule cds by nortonsimon modeling. Additional phase 2 trials currently are testing the capecitabine 77 dosing schedule in combination with other targeted therapies. Reduce the starting dose of capecitabine by 25% from 1,250 mgm2 to 950 mgm2 when used either as monotherapy or in combination with docetaxel. Renal dose adjustmentsmild renal impairment crcl 51 to 80 mlmin.
It is an orally administered systemic prodrug of 5deoxy5fluorouridine 5dfur which is. Capecitabine tablets usp are indicated as a single agent for adjuvant treatment in patients with dukes c colon cancer who have undergone complete resection. Low dose capecitabine xeloda for treatment for gastrointestinal cancer. No adjustment to the starting dose of xeloda is recommended in patients with mild renal impairment creatinine clearance 51 to 80 mlmin cockroft and gault, as shown below. Xeloda capecitabine dosing, indications, interactions. The recommended dosage of ixempra is 40 mgm 2 administered intravenously over 3 hours every 3 weeks 2doses for patients with body surface area greater than 2. Impaired renal function estimated creatinine clearance capecitabine dosage information for adults.
Capecitabine, an oral fluoropyrimidine that mimics continuous infusion 5fluorouracil 5fu, is now recognized as a standard treatment after failure of anthracycline and taxane therapy in. Dihydropyrimidine dehydrogenase dpd, an enzyme encoded by the dpyd gene, is the ratelimiting step in pyrimidine catabolism and deactivates 80% of 5fu standard doses and the 5fu prodrug capecitabine. This medicine is used to treat breast cancer, and also colon or rectal cancer. Patients with moderate renal impairment crcl 30 to 50. For example, the medication is likely to cause harm to an unborn fetus when the. Capecitabine xeloda is an orally administered precursor of 5deoxy5fluorouridine, which is a preferentially activated to 5fluorouracil in tumors. The primary objective of this study was to investigate the influence of renal impairment on the pharmacokinetics of capecitabine and its metabolites in cancer patients. Includes dosages for breast cancer and colorectal cancer. Capecitabine is supplied as biconvex, oblong filmcoated tablets for oral administration. Clinical experience with capecitabine has shown that the agent is a valuable substitute for bolus or infusional 5fu, either as monotherapy or in combination with other cytotoxic drugs. Following oral administration of 1250 mgm 2 capecitabine twice a day to cancer patients with varying degrees of renal impairment, patients with moderate creatinine clearance 30 to 50. By contrast, renal impairment may lead to decreased exposure to 5dfcr.
Optimizing chemotherapeutic doseschedule cds by norton. Capecitabine, sold under the brand name xeloda among others, is a chemotherapy medication used to treat breast cancer, gastric cancer and colorectal cancer. Capecitabine xeloda and radiation for patients with. Capecitabine is only part of a treatment program that may also include other medications taken on different schedules. To help prevent this, protect your hands and feet from heat or increased pressure. Pdf safety of capecitabine use in patients with liver. There was no evidence for an effect of renal impairment on systemic exposure to 5fu or capecitabine. Should your health care professional modify your dose, indicate the new dosage in the a. No adjustment recommendedmoderate renal impairment crcl 30 to 50 mlmin. Xeloda capecitabine dose, indications, adverse effects.
In the united states, poor patient tolerability of the standard capecitabine dosing regimen 1250 mgm 2 twice daily on days 114 administered every 21 days limits the established benefit of the agent. Results from such a study will fill a huge knowledge gap benefitting the emerging elderly population with crc. The recommended dosing schedule is oral capecitabine mgm2 twice daily. Capecitabine in metastatic breast and gi cancers full. The table has already been completed for you under the rest period. An awareness of the precautions and warnings with capecitabine can help ensure a safe, successful treatment process. Dosage adjustment for cytotoxics in renal impairment. Xeloda dosage may need to be individualized to optimize patient management 2. Ixempra ixabepilone dosing and administration guide. Uclh dosage adjustment for cytotoxics in renal impairment version 3 updated january2009 page 3 of 24 drug pharmacokinetics available information recommendation arsenic trioxide arsenic is stored mainly in liver, kidney, heart, lung, hair and nails. Safety and efficacy of two different doses of capecitabine in the. Pediatric drugs analgesics antihypertensive and cardiovascular agents antimicrobial agents miscellaneous agents sedatives, hypnotics, and other drugs used in psychiatry. Capecitabine in the treatment of metastatic renal cell carcinoma article in british journal of cancer 835. Interrupt capecitabine treatment until dehydration is corrected.
Systemic exposure to 5dfur was 42% and 71% greater in moderately and severely renal impaired patients, respectively, than in normal patients. The pharmacokinetic data translate into a clear recommendation that physicians should tailor capecitabine dose on the basis of renal function 2025% reduction in standard dose for a. Capecitabine may make you develop a skin problem called handfoot syndrome. Dosage and administration take xeloda with water within 30 min after a meal 2 monotherapy. Capecitabine in metastatic breast and gi cancers x77 the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. It is used in the treatment of colorectal, gastric, and. Xeloda capecitabine is a drug used to treat breast cancer that has metastasized to other tissues, as well as colon and colorectal cancers that have spread to lymph nodes and other parts of the body. Capecitabine is contraindicated in patients with severe renal impairment or renal failure creatinine clearance crcl less than 30 mlmin. At that time, it was not already known that a lower dose of capecitabine is actually recommended for patients with moderate renal impairment at.