Posted on May 11, 2016
There are no adequate and well controlled studies of capecitabine in pregnant women. If this drug is used during pregnancy or if a patient becomespregnant while receiving capecitabine, the patient should be apprised of the potential hazard to the fetus. Women should be advised to avoid becomingpregnant while receiving treatment with capecitabine [see Warnings and Precautions (5.6)]. 5-fu warfarin.
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The manifestations of acute overdose would include nausea, vomiting, diarrhea, gastrointestinal irritation and bleeding and bone marrow depression.Medical management of overdose should include customary supportive medical interventions aimed at correcting the presenting clinical manifestations.Although no clinical experience using dialysis as a treatment for capecitabine overdose has been reported, dialysis may be of benefit in reducingcirculating concentrations of 5’-DFUR, a low–molecular-weight metabolite of the parent compound.
The antitumor activity of capecitabine as a monotherapy was evaluated in an open-label single-arm trial conducted in 24 centers in the US and Canada.A total of 162 patients with stage IV breast cancer were enrolled. The primary endpoint was tumor response rate in patients with measurable disease,with response defined as a ≥ 50% decrease in sum of the products of the perpendicular diameters of bidimensionally measurable disease for at least onemonth. Capecitabine was administered at a dose of 1255 mg/m2 twice daily for 2 weeks followed by a 1 week rest period and given as 3 week cycles. Thebaseline demographics and clinical characteristics for all patients (n = 162) and those with measurable disease (n = 135) are shown in Table 18.Resistance was defined as progressive disease while on treatment, with or without an initial response or relapse within 6 months of completingtreatment with an anthracycline-containing adjuvant chemotherapy regimen. 5-fu warfarin user .
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In 875 patients with either metastatic breast or colorectal cancer who received at least one dose of capecitabine 1250 mg/m2 twice daily asmonotherapy for 2 weeks followed by a 1 week rest period, grade 3 (1.5 to 3 x ULN) hyperbilirubinemia occurred in 15.2% (n = 133) of patients andgrade 4 (> 3 x ULN) hyperbilirubinemia occurred in 3.9% (n = 34) of patients. Of 566 patients who had hepatic metastases at baseline and 309patients without hepatic metastases at baseline, grade 3 or 4 hyperbilirubinemia occurred in 22.8% and 12.3%, respectively. Of the 167 patients withgrade 3 or 4 hyperbilirubinemia, 18.6% (n = 31) also had post-baseline elevations (grades 1 to 4, without elevations at baseline) in alkalinephosphatase and 27.5% (n = 46) had post-baseline elevations in transaminases at any time (not necessarily concurrent). The majority of these patients,64.5% (n = 20) and 71.7% (n = 33), had liver metastases at baseline. In addition, 57.5% (n = 96) and 35.3% (n = 59) of the 167 patients had elevations(grades 1 to 4) at both pre-baseline and post-baseline in alkaline phosphatase or transaminases, respectively. Only 7.8% (n = 13) and 3% (n = 5) hadgrade 3 or 4 elevations in alkaline phosphatase or transaminases.
The dose of phenytoin and the dose of coumarin-derivative anticoagulants may need to be reduced when either drug is administered concomitantly withcapecitabine tablets [see Drug Interactions (7.1)]. 5-fu warfarin.
Patients with mild to moderate hepatic dysfunction due to liver metastases should be carefully monitored when capecitabine is administered. The effectof severe hepatic dysfunction on the disposition of capecitabine is not known [see Use in Specific Populations (8.6) and Clinical Pharmacology(12.3)].
5-fu warfarin The dose of capecitabine used in the phase 3 clinical trial in combination with docetaxel was based on the results of a phase 1 study, where a rangeof doses of docetaxel administered in 3 week cycles in combination with an intermittent regimen of capecitabine (14 days of treatment, followed by a 7day rest period) were evaluated. The combination dose regimen was selected based on the tolerability profile of the 75 mg/m2 administered in 3 weekcycles of docetaxel in combination with 1250 mg/m2 twice daily for 14 days of capecitabine administered in 3 week cycles. The approved dose of 100mg/m2 of docetaxel administered in 3 week cycles was the control arm of the phase 3 study. .
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The recommended dose of capecitabine was determined in an open-label, randomized clinical study, exploring the efficacy and safety of continuoustherapy with capecitabine (1331 mg/m2/day in two divided doses, n = 39), intermittent therapy with capecitabine (2510 mg/m2/day in two divided doses,n = 34) and intermittent therapy with capecitabine in combination with oral leucovorin (LV) (capecitabine 1657 mg/m2/day in two divided doses, n = 35;leucovorin 60 mg/day) in patients with advanced and/or metastatic colorectal carcinoma in the first-line metastatic setting. There was no apparentadvantage in response rate to adding leucovorin to capecitabine; however, toxicity was increased. Capecitabine, 1250 mg/m2 twice daily for 14 daysfollowed by a 1 week rest, was selected for further clinical development based on the overall safety and efficacy profile of the three schedulesstudied.5-fu warfarin.
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Care should be exercised in the handling of capecitabine. Capecitabine tablets should not be cut or crushed. The use of gloves and safety glasses isrecommended to avoid exposure in case of breakage of tablets. If powder from broken capecitabine tablets contacts the skin, wash the skin immediatelyand thoroughly with soap and water. If capecitabine contacts the mucous membranes, flush thoroughly with water. 5-fu warfarin.
Oxazaphosphorines such as cyclophosphamide and ifosfamide; taxanes such as paclitaxel and docetaxel; and lapatinib, sorafenib, nilotinib, dasatinib,imatinib, sunitinib, and erlotinib are all partly metabolized by CYP3A4. Combining these drugs with other CYP3A4 substrates, inducers, or inhibitorswill affect their action. Cyclophosphamide is a reversible inhibitor of CYP3A4, so caution should be exercised when this drug is used with otherCYP3A4 substrates, such as those listed in TABLE 2.15,20
5-fu warfarin The safety and effectiveness of capecitabine in pediatric patients have not been established. .
5-fu warfarin.There are many reasons why a cookie could not be set correctly. Below are the most common reasons:
Additionally, since most antineoplastic agents affect the gastrointestinal mucosa, they have the potential to interfere with the absorption of otherorally administered drugs.18
ABSTRACT: Precise data are not available, but the occurrence of drug-drug interactions in oncology is theorized to be higher than in most otherconditions. The three primary types of drug interactions are pharmaceutical, pharmacodynamic, and pharmacokinetic. Metabolic interactions are the mostcommon, but other types of interactions can occur in patients undergoing chemotherapy. It is important for pharmacists to competently advise patientsabout what to expect and to make appropriate recommendations to other health care professionals. 5-fu warfarin.
Capecitabine has been evaluated in clinical trials in combination with docetaxel (Taxotere®) and as monotherapy. 5-fu warfarin user
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What should I avoid while taking capecitabine tablets?
In studies of fertility and general reproductive performance in female mice, oral capecitabine doses of 760 mg/kg/day (about 2300 mg/m2/day) disturbedestrus and consequently caused a decrease in fertility. In mice that became pregnant, no fetuses survived this dose. The disturbance in estrus wasreversible. In males, this dose caused degenerative changes in the testes, including decreases in the number of spermatocytes and spermatids. Inseparate pharmacokinetic studies, this dose in mice produced 5’-DFUR AUC values about 0.7 times the corresponding values in patients administered therecommended daily dose. 5-fu warfarin user .
General: Patients receiving therapy with capecitabine should be monitored by a physician experienced in the use of cancer chemotherapeutic agents.Most adverse reactions are reversible and do not need to result in discontinuation, although doses may need to be withheld or reduced [see Dosage andAdministration (2.2)].
Access and take the CME test online and receive 1 hour of AMA PRA category 1 credit at CME.TheOncologist.com 5-fu warfarin user .
Doxorubicin and vinblastine are also metabolized by CYP2D6 enzymes. The abovementioned drugs, therefore, will have a similar effect on doxorubicin andvinblastine.
Contact your health care provider immediately, day or night, if you should experience any of the following symptoms: , , .