Dosage of Ecansya in details
Standard
Dosage: Monotherapy: Colon, Colorectal and Breast Cancer:The recommended monotherapy starting dose of Ecansya is 1250 mg/m2 administered twice daily (morning and evening; equivalent to 2500 mg/m2 total daily dose) for 2 weeks followed by a 7-day rest period.
Combination Therapy: Breast Cancer:In combination with docetaxel, the recommended starting dose of Ecansya is 1250 mg/m2 twice daily for 2 weeks followed by a 7-day rest period, combined with docetaxel at 75 mg/m2 as a 1 hour intravenous infusion every 3 weeks. Premedication, according to the docetaxel labeling, should be started prior to docetaxel administration for patients receiving the Ecansya plus docetaxel combination.
Colon, Colorectal, Gastric and Oesophagogastric Cancer:In combination treatment (except with irinotecan), the recommended starting dose of Ecansya is 800 to 1000 mg/m2 administered twice daily for 2 weeks followed by a 7-day rest period, or 625 mg/m2 twice daily when administered continuously. For combination with irinotecan (XELIRI), the recommended starting dose of Ecansya is 800 mg/m2 administered twice daily for 2 weeks followed by a 7-day rest period in combination with irinotecan 200 mg/m2 on day 1 of each three week cycle.
The inclusion of bevacizumab in a combination regimen has no effect on the starting dose of Ecansya. Adjuvant treatment in patients with stage III colon cancer is recommended for a total of 6 months.
Premedication to maintain adequate hydration and anti-emesis according to the cisplatin and oxaliplatin product information should be started prior to cisplatin administration for patients receiving the Ecansya plus cisplatin or oxaliplatin combination.
Ecansya dose is calculated according to body surface area. The following tables show examples of the standard and reduced dose calculations for a starting dose of Ecansya of either 1250 mg/m2 or 1000 mg/m2.
Dosage Adjustments During Treatment: General: Toxicity due to Ecansya administration may be managed by symptomatic treatment and/or modification of the Ecansya dose (treatment interruption or dose reduction). Once the dose has been reduced it should not be increased at a later time.
For those toxicities considered by the treating physician to be unlikely to become serious or life-threatening treatment can be continued at the same dose without reduction or interruption.
Dosage modifications are not recommended for Grade 1 events. Therapy with Ecansya should be interrupted if a Grade 2 or 3 adverse experience occurs. Once the adverse event has resolved or decreased in intensity to Grade 1, Ecansya therapy may be restarted at full dose or as adjusted according to Table 7. If a Grade 4 experience occurs, therapy should be discontinued or interrupted until the experience has resolved or decreased to Grade 1, and therapy can then be restarted at 50% of the original dose. Patients taking Ecansya should be informed of the need to interrupt treatment immediately if moderate or severe toxicity occurs. Doses of Ecansya omitted for toxicity are not replaced.
Haematology: Patients with baseline neutrophil counts of <1.5 x 109/L and/or thrombocyte counts of <100 x 109/L should not be treated with Ecansya. If unscheduled laboratory assessments during a treatment cycle show grade 3 or 4 haematologic toxicity, treatment with Ecansya should be interrupted.
Table 7 shows the recommended dose modifications following toxicity related to Ecansya:
General Combination Therapy: Dose modifications for toxicity when Ecansya is used in combination with other therapies should be made according to Table 7 above for Ecansya and according to the appropriate Prescribing Information for the other agent(s).
At the beginning of a treatment cycle, if a treatment delay is indicated for either Ecansya or the other agent(s), then administration of all agents should be delayed until the requirements for restarting all drugs are met.
During a treatment cycle for those toxicities considered by the treating physician not to be related to Ecansya, Ecansya should be continued and the dose of the other agent adjusted according to the appropriate Prescribing Information.
If the other agent(s) have to be discontinued permanently, Ecansya treatment can be resumed when the requirements for restarting Ecansya are met.
This advice is applicable to all indications and to all special populations.
Special Dosage Instructions: Patients with Hepatic Impairment Due to Liver Metastases: In patients with mild to moderate hepatic impairment due to liver metastases, no starting dose adjustment is necessary. However, such patients should be carefully monitored. Patients with severe hepatic impairment have not been studied.
Patients with Renal Impairment:In patients with moderate renal impairment [creatinine clearance 30-50 mL/min (Cockroft and Gault)] at baseline, a dose reduction to 75% for a starting dose of 1250 mg/m2 is recommended. In patients with mild renal impairment (creatinine clearance 51-80 mL/min), no adjustment in starting dose is recommended.
Careful monitoring and prompt treatment interruption is recommended if the patient develops a Grade 2, 3, or 4 adverse event with subsequent dose adjustment as outlined in Table 7 previously. If the calculated creatinine clearance decreases during treatment to a value below 30 mL/min, Ecansya should be discontinued. The dose adjustment recommendations for patients with moderate renal impairment apply both to monotherapy and combination use. For dosage calculations, see Tables 5 and 6.
Children:The safety and efficacy of Ecansya in children have not been established.
Elderly: For Ecansya monotherapy, no adjustment of the starting dose is needed. However, severe Grade 3 or 4 treatment-related adverse events were more frequent in patients over 80 years of age compared to younger patients.
When Ecansya was used in combination with other agents, elderly patients (≥65 years) experienced more Grade 3 and Grade 4 adverse drug reactions (ADRs) and ADRs that led to discontinuation, than younger patients. Careful monitoring of elderly patients is advisable.
In Combination with Docetaxel: An increased incidence of Grade 3 or 4 treatment-related adverse events and treatment-related serious adverse events was observed in patients 60 years of age or more. For patients 60 years of age or more treated with the combination of Ecansya plus docetaxel, a starting dose reduction of Ecansya to 75% (950 mg/m2 twice daily) is recommended. For dosage calculations, see Table 5.
What other drugs will affect Ecansya?
If you take a blood thinner (warfarin, Coumadin, Jantoven), you may need to have more frequent "INR" or prothrombin time tests. Taking a blood thinner can increase your risk of severe bleeding while you are using Ecansya, and for a short time after you stop taking Ecansya. This risk is higher in adults older than 60.
Other drugs may interact with Ecansya, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.
Ecansya interactions
Coumarin Anticoagulants: Altered coagulation parameters and/or bleeding have been reported in patients taking Ecansya concomitantly with coumarin-derivative anticoagulants eg, warfarin and phenprocoumon. These events occurred within several days and up to several months after initiating Ecansya therapy and in a few cases, within 1 month after stopping Ecansya. In a clinical interaction study, after a single 20-mg dose of warfarin, Ecansya treatment increased the AUC of S-warfarin by 57% with a 91% increase in INR value. Patients taking coumarin-derivative anticoagulants concomitantly with Ecansya should be monitored regularly for alterations in their coagulation parameters (PT or INR) and the anticoagulant dose adjusted accordingly.
Cytochrome P450 (CYP450) 2C9 Substrates: No formal drug-drug interaction studies with Ecansya and other drugs known to be metabolized by the CYP450 2C9 isoenzyme have been conducted. Care should be exercised when Ecansya is co-administered with these drugs.
Phenytoin: Increased phenytoin plasma concentrations have been reported during concomitant use of Ecansya with phenytoin. Formal drug-drug interaction studies with phenytoin have not been conducted, but the mechanism of interaction is presumed to be inhibition of the CYP2C9 isoenzyme system by Ecansya. Patients taking phenytoin concomitantly with Ecansya should be regularly monitored for increased phenytoin plasma concentrations.
Drug-Food Interaction: In all clinical trials, patients were instructed to take Ecansya within 30 min after a meal. Since current safety and efficacy data are based upon administration with food, it is recommended that Ecansya be administered with food.
Antacid: The effect of an aluminium hydroxide and magnesium hydroxide-containing antacid on the pharmacokinetics of Ecansya was investigated in cancer patients. There was a small increase in plasma concentrations of Ecansya and 1 metabolite (5'DFCR); there was no effect on the 3 major metabolites (5'DFUR, 5-FU and FBAL).
Leucovorin Folinic Acid: The effect of leucovorin on the pharmacokinetics of Ecansya was investigated in cancer patients. Leucovorin has no effect on the pharmacokinetics of Ecansya and its metabolites. However, leucovorin has an effect on the pharmacodynamics of Ecansya and its toxicity may be enhanced by leucovorin.
Sorivudine and Analogues: A clinically significant drug-drug interaction between sorivudine and 5-FU, resulting from the inhibition of dihydropyrimidine dehydrogenase by sorivudine, has been described in the literature. This interaction, which leads to increased fluoropyrimidine toxicity, is potentially fatal. Therefore, Ecansya should not be administered with sorivudine or its chemically related analogues eg, brivudine. There must be at least a 4-week waiting period between the end of treatment with sorivudine or its chemically related analogues eg, brivudine and start of Ecansya therapy.
Oxaliplatin: No clinically significant differences in exposure to Ecansya or its metabolites, free platinum or total platinum occured when Ecansya or oxaliplatin were administered in combination with or without bevacizumab.
Bevacizumab: There was no clinically significant effect of bevacizumab on the pharmacokinetic parameters of Ecansya or its metabolites.
References
- DailyMed. "CAPECITABINE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- FDA/SPL Indexing Data. "6804DJ8Z9U: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Data... (accessed September 17, 2018).
- MeSH. "Antimetabolites, Antineoplastic". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Ecansya are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Ecansya. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
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Information checked by Dr. Sachin Kumar, MD Pharmacology
