Proposed indication and dosing regimen indication sutent is indicated for the adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma rcc following. If dose is increased, the patient should be monitored carefully for toxicity. Read the medication guide provided by your pharmacist before you start taking sunitinib and each time you get a refill. The investigators tested the alternative schedule as a way to reduce the ratio of severe adverse events. The renal adverse effects raes of sunitinib have not been investigated. Fda approves sunitinib malate for adjuvant treatment of. Sutent sunitinib malate dose, indications, adverse.
Dosing sunitinib and pazopanib in renal cell carcinoma. Sunitinib in combination with gemcitabine for advanced. Sutent is approved to treat the portion of patients whose cancer is advanced. Fda advisory committee split on opinion of adjuvant sutent. The objective of this study was to investigate the significance of an alternative dosing schedule for sunitinib in metastatic renal cell carcinoma mrcc patients. The recommended dose is 50 mg once daily for 4 weeks followed by a 2 weeks break. Pdf alternative dosing schedules for sunitinib as a. However, some studies have suggested that an alternate dosing and scheduling for sunitinib. The approval was based on results from the strac trial that.
Alternate dose schedules for sunitinib were explored in clinical studies with the goal of improving drug tolerance and dose intensity table 1. Md, elaborate on the dosing of tyrosine kinase inhibitors, sunitinib, and pazopanib, in renal cell carcinoma rcc. Sunitinib is an oral, smallmolecule, multitargeted receptor tyrosine kinase rtk inhibitor that was approved by the fda for the treatment of renal cell carcinoma rcc and imatinibresistant. If dose is increased, the patient should be monitored carefully for toxicity see drug interactions 7. We observed one partial response and two patients had stable disease for 24 and 4 months, respectively. Dose reduction below 50 mg has been reported in more than one third of. Up to 30% of patients with renal cell carcinoma present with metastatic disease 2, 3 and recurrence develops in. The recommended dosages for each type of cancer are below. A dose reduction occurred in 50% of patients in the sunitinib group and 27% of patients in the ifn group. Multiple dosage strengths may enable patients to take 1 capsule per day. Manufacturer advises if concurrent use of potent inducers of cyp3a4 is unavoidable, dose may need to be increased in steps of 12. For gist and metastatic renal cell carcinoma, sutent is given in sixweek cycles, at a dose of 50 mg once a day for four weeks, followed by a twoweek rest period. The initial sunitinib dose was 50 mg for 33 patients 56.
For the treatment of advanced renal cell carcinoma rcc for the treatment of gastrointestinal stromal tumor gist after disease progression on or intolerance to imatinib. August 2015 prescribing information can be found at the end of the document. Sunitinib was developed by sugen, a south san francisco biotechnology company that later merged with. Significance of introduction of alternative dosing. Subsequent dose adjustments should be based on individual safety and tolerability. Three patients tolerated treatment well with no renal toxicity. In large clinical trials of sunitinib, elevations in serum aminotransferase. Sutent sunitinib malate is indicated for the treatment of gastrointestinal stromal tumor gist after disease progression on or intolerance to imatinib mesylate. Sunitinib dose escalation in metastatic renal cell carcinoma. Renal adverse effects of sunitinib and its clinical. Pediatric drugs analgesics antihypertensive and cardiovascular agents antimicrobial agents miscellaneous agents sedatives, hypnotics, and other drugs used in psychiatry. About 60,000 people in the united states are diagnosed with kidney cancer renal cell carcinoma or rcc each year. The results suggest that the superior efficacy of nivolumab plus ipilimumab over sunitinib was maintained in intermediaterisk or poorrisk and intentiontotreat patients with extended followup, and show the longterm benefits of nivolumab plus ipilimumab in patients with previously untreated advanced renal cell carcinoma across all risk categories. Alternate sunitinib schedules in patients with metastatic.
Sunitinib rechallenge in metastatic renal cell carcinoma. No dose adjustment necessary with any degree of renal impairment in patients. Sunitinib has been a standard treatment for patients with metastatic renal cell carcinoma mrcc since 2006. Most oral agents for renal cell carcinoma rcc are currently given in a continuous schedule. Its important to remember to take sutent as directed by your healthcare team. Sunitinib versus interferon alfa in metastatic renalcell. Sunitinib sutent is is an oral, smallmolecule, multitargeted receptor tyrosine kinase inhibitor that was approved by the fda for the treatment of renal cell carcinoma and imatinibresistant gastrointestinal stromal tumor. However, in clinical practice, only few patients have been able to tolerate more than 50 mg. The tyrosine kinase inhibitor sunitinib has been a standard of care in the 1stline treatment of mrcc for more than a decade. Dose adjustments are recommended when sutent is administered with cyp3a4 inhibitors or inducers. The optimal dosing schedule to maintain the effectiveness of sunitinib for metastatic renal cell carcinoma while reducing toxicity remains an. If concomitant use is unavoidable, consider increasing the dose of sunitinib to a maximum of 87. Optimising care for patients on sutent sunitinib malate.
Click here for a specialized list of other renal medication dosing not listed in the alphabetical main section simple renal dosing guidelines. Sunitinib dose escalation in metastatic renal cell carcinoma ios. Sutent dosage for renal cell carcinoma rcc the standard dose of sutent for the treatment of advanced rcc kidney cancer is 50 mg once a day for four weeks, followed by. No adjustment to starting dose quired wheis ren administering sutent to patients with mild or moderate hepatic impairment or with renal impairment see section 5. Sunitinib was the first cancer drug simultaneously approved for two different. Sunitinib remains effective with shorter dosing schedule in renal cell. A 2 weeks on and 1 week off schedule of sunitinib is associated with. If you have any questions, ask your doctor or pharmacist. Longterm dialysis is a risk factor since prevalence in hemodialysis and renal transplant patients is 40100 times higher than in the general. Most people, now, who still use sunitinib at firstline therapy for patients with clear cell renal cell carcinoma rcc, use the ultimate scheduling of two weeks on, one week off, instead of the. Sunitinib treatment in patients with severe renal function.
Dosing information sutent sunitinib malate capsules. Sunitinib is primarily eliminated with the feces 61%, with renal elimination accounting for only 16% of the administered dose. Safety and effectiveness of classical and alternative sunitinib dosing. Chicago sunitinib administered for 2 weeks followed by 1 week off induced strong response rates in patients with metastatic renal cell. The dose reduction rate in the phase iii pazopanib versus sunitinib in the treatment of locally advanced andor metastatic renal cell. The recommended dose of sutent for gastrointestinal stromal tumor gist and advanced renal cell carcinoma rcc is one 50mg oral dose taken once daily, on a. Sutent sunitinib malate dose, indications, adverse effects. Sutent sunitinib dosing, indications, interactions. Uncommon side effects include heart failure, pancreatitis and renal failure. The starting dose of sunitinib for rechallenge was 50 mg for 12 patients 52%, 37.
Phase ii study of two weeks on, one week off sunitinib scheduling. Treatment of metastatic renal cell carcinoma mrcc with sunitinib is often associated with toxicity necessitating dose reduction. Dose interruptions may be required based on individual safety and tolerability. The level of renal function below which the dose of a drug must be reduced depends largely on the extent of renal metabolism and elimination, and on the drugs.
What is the most important information i should know about sutent. Alternate sunitinib schedules may benefit some with. The authors make no claims of the accuracy of the information contained herein. Sunitinib marketed as sutent by pfizer, and previously known as su11248 is an oral, smallmolecule, multitargeted receptor tyrosine kinase rtk inhibitor that was approved by the fda for the treatment of renal cell carcinoma rcc and imatinibresistant gastrointestinal stromal tumor gist on january 26, 2006. This phase i, dose finding study determined the maximum tolerated dose mtd, safety, and pharmacokinetics of sunitinib plus gemcitabine in patients with advanced solid tumours.
Your dose is taken by mouth once daily, with or without food. Alternative sunitinib regimen for advanced rcc proposed. Pembrolizumab plus axitinib versus sunitinib for advanced. Clearcell renal carcinoma is the most common cancer of the kidney. A companion to braunwalds heart disease second edition, 2011. Sutent sunitinib malate is indicated for the treatment of advanced renal cell carcinoma rcc, gastrointestinal stromal tumor gist after disease progression on or intolerance to imatinib mesylate, and progressive, wellindifferentiated pancreatic neuroendocrine tumors pnet in. The recommended dose of sutent for gastrointestinal stromal tumor gist and advanced renal cell carcinoma rcc is one 50 mg oral dose taken once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off schedule 42. Median followup defined as the time from randomization to death or the date of data cutoff for. Adult drugs analgesics antihypertensive and cardiovascular agents antimicrobial agents miscellaneous agents sedatives, hypnotics, and other drugs used in. For the adjuvant treatment of renal cell cancer rcc in patients at high risk of recurrence following nephrectomy. Patients assigned sunitinib received 50mg doses for 4 weeks following by 2 weeks off, and the dose could be reduced to 37. Sunitinib marketed as sutent, previously known as su11248 is a smallmolecule receptor tyrosine kinase inhibitor that is approved for the treatment of gist and renal cell carcinoma goodman et al.
Pharmacokinetics of sunitinib in hemodialysis annals of. Sunitinib is an oral multitargeted tyrosine kinase inhibitor used mainly for the treatment of metastatic renal cell carcinoma. The dose can be adjusted according to the patients response to the treatment, but should be kept within the range of 25 to 75 mg. Dose reductions were required in 50% of the patients studied in rcc in order to manage the significant toxicities of this agent. This study included 154 patients treated with sunitinib as firstline systemic therapy for mrcc, consisting of 62, 47, and 45 receiving sunitinib based on a traditional schedule ts, 4 weeks on and 2 weeks off alone ts group. Sutent sunitinib dosing, indications, interactions, adverse effects. Nivolumab plus ipilimumab versus sunitinib in firstline. Individualized treatment with sunitinib versus standard dosing with. Individualized treatment with sunitinib versus standard dosing with sunitinib or pazopanib in patients with metastatic renal cell carcinoma.
439 1248 1579 565 1250 216 214 556 771 1575 1268 365 57 679 142 315 1124 1442 469 1222 122 1476 1060 877 763 145 1242 169 1327 745 1383 1109 343 4 1182