Not recommended if severe renal impairment or endstage renal disease. Healthcare providers may consider the once weekly dosing as an option for type 2 diabetic patients who have had success with exenatide twice daily but would benefit from minimizing. Alternatively, may give before the two main meals of the day provided dosing is 6 hours or more apart. Exenatide is an injectable treatment for type 2 diabetes. Effect of renal impairment on the pharmacokinetics of exenatide. Byetta should not be used in patients with severe renal impairment creatinine. Bydureon is intended for patient selfadministration. In ckd stage 4 and 5 clearance dosage adjustment required. Drug dosage in renal insufficiency has become an toxication. Exenatide is excreted only by the kidneys and undergoes fragmentation in the renal tubule. A prefilled pen with 60 doses of exenatide one month supply costs.
Renal dosage adjustment guidelines for antimicrobials. The combined analysis showed that, whilst exenatide clearance decreased % in the mildri group compared with subjects with a normal renal function, tolerability of exenatide 10 g was acceptable and this reduction in clearance was not considered clinically relevant. Case report olgu sunumu, case study by turkish journal of endocrinology and metabolism. Exenatide is a glucagonlike peptide1 receptor agonist, available in an immediaterelease ir, twicedaily formulation, which improves glycaemic control through enhancement of glucosedependent insulin secretion, suppression of inappropriately elevated postprandial glucagon secretion, slowing of gastric emptying and reduction of food intake. In these animal studies, exenatide was given in doses 3 to 12 times the human dose, based on the maximum recommended dose of 20 mcgday determined from auc. Lilly camp care packages, supplying children at diabetes camps with book. Byetta exenatide dosing, indications, interactions, adverse. Health, general acute kidney failure care and treatment case studies complications and side effects diagnosis risk factors acute renal failure diabetes diabetes mellitus. Byetta exenatide dosing, indications, interactions, adverse effects. Bydureon bcise exenatide extendedrelease injectable. The mean antixa level in the severe renal impairment group after a dose adjustment was 0.
Exenatide and kidney function nephrology jama jama network. Apr 14, 2020 a 2year carcinogenicity study was conducted with exenatide extendedrelease, the active component of bydureon, in male and female rats at doses of 0. Bydureon exenatide dose, indications, adverse effects. Renal dosing, risk of hypoglycemia, and fuid balance must be considered when choosing an appropriate antihyperglycemic agent in the presence of renal impairment,14. Objective in patients with type 2 diabetes, exenatide reduces a1c, postprandial and fasting glucose, and weight.
Exenatide associated renal failure article in practical diabetes international 276. Munar, pharmd, bcps, and harleen singh, pharmd oregon state university college of pharmacy, portland, oregon. Renal dosage adjustment guidelines for antimicrobials the pharmacists will automatically adjust the doses of any of the antimicrobials included in the protocol according to the estimated creatinine clearance generally using the cockroftgault equation for patients. Compared to glp1, exenatide has a longer halflife of 2. It is unknown whether this drug causes thyroid ccell tumors, including medullary thyroid carcinoma mtc, in humans, as the human relevance of exenatideextendedreleaseinduced rodent thyroid ccell.
Exenatide pharmacokinetics in patients with mild to moderate. The scottish medicines consortium has advised july 2007 that standardrelease exenatide byetta is accepted for restricted use within nhs scotland for the treatment of type 2 diabetes in combination with metformin or sulfonylurea or both, as an alternative to treatment with insulin in patients where treatment with metformin or sulfonylurea or both at maximally tolerated doses has. The fda has issued a warning about exenatide the same day the agency approved its firstline use along with diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus. Use with caution in patients with renal transplantationor moderate renal impairment 5. Effect of renal impairment on the pharmacokinetics of. Exenatide is fdaindicated to improve glycemic control in adult patients with type 2.
Dosing guidelines book school of medicine university of. In 1975, his poison index was pub important facet of nephrology, a subspeciality of lished, first in german, and two years later in internal medicine which is only 30 years young but english, with supplements in 1979 and 1983. The mean antixa level in the moderate renal impairment group after a dose adjustment was 0. In kidney malfunction, or even renal failure, the dose of sitagliptin must be reduced to onehalf or onefourth.
The authors make no claims of the accuracy of the information contained herein. In kidney malfunction, or even renal failure, the dose of sitagliptin must be reduced to onehalf or one fourth. Medscape type 2 diabetesspecific dosing for byetta exenatide. Prior to initiation, train patients on proper mixing and injection technique to ensure the product is adequately mixed and a full dose is delivered. The day of weekly administration can be changed if necessary as long as the last dose was administered 3 or more days before the new day of administration.
A 2year carcinogenicity study was conducted with exenatide extendedrelease, the active component of bydureon, in male and female rats at doses of 0. Drug dosing adjustments in patients with chronic kidney disease myrna y. After 1 month, may increase dose to 10 mcg subcutaneously twice a day based on clinical response. Drug dosing adjustments in patients with chronic kidney disease. Pancreatitis, allergic reactions and altered kidney function have been reported rarely with exenatide. The information on dosage adjustments in renal impairment given in this book is. Exenatide was approved for medical use in the united states in 2005. Bydureon bcise exenatide dose, indications, adverse effects. Apr 10, 2007 exenatide 5 or 10 g was injected subcutaneously in 31 subjects one with type 2 diabetes stratified by renal function cockcroftgault creatinine clearance crcl, number of subjects.
Exenatide pharmacokinetics in patients with mild to moderate renal dysfunction and end stage renal disease exenatide, an incretin mimetic exenatide, an incretin mimetic with antihyperglycemic actions, is under clinical investigation to treat type 2 diabetes. Exenatide is a 39 amino acid peptide and synthetic version of exendin4, a hormone found in the saliva of the venomous lizard gila monster, with insulin secretagogue and antihyperglycemic activity. Use of exenatide in patients with type 2 diabetes diabetes. If last enoxaparin was given 812 hr before balloon inflation, an iv bolus of 0. We evaluated 6,510 patients started on exenatide, 16,155 patients started on a sulfonylurea, metformin or thiazolidinedione dm control, and 745,844 nondiabetic patients nondm control. Recovery of renal function was incomplete in three of four patients upon cessation or dose reduction of the medication. Exenatide is not recommended for use in patients with endstage renal disease or severe renal impairment creatinine clearance dosing is needed. The united states food and drug administration fda reported that between april 2005 and october 2008 there were 78 cases of altered kidney function 62 cases of acute renal failure and 16 cases of renal insufficiency with exenatide. Bydureon is 2 mg exenatide extendedrelease for injectable suspension for subcutaneous administration once every seven days weekly. Postmarketing reports of altered renal function have been documented, including increased serum creatinine, renal impairment, worsened chronic renal failure and acute renal failure, sometimes. Exenatide is not associated with increased acute renal failure. In this study we investigated the effects of continuous exenatide administration from a longacting release lar formulation.
Exenatideassociated ischemic renal failure diabetes care. Exenatide extendedrelease causes an increased incidence in thyroid ccell tumors at clinically relevant exposures in rats compared to controls. Analgesics antihypertensive and cardiovascular agents antimicrobial agents miscellaneous agents sedatives, hypnotics, and other drugs used in psychiatry. Exenatide is administered subcutaneously and mimics human glucagon like peptide1 glp1. Vice versa, switching from sitagliptin to exenatide produced a decrease of 73 mgdl in 2h ppg level. Patients with previous arf, endstage renal disease, or dialysis were excluded. Postmarketing reports with exenatide, sometimes requiring hemodialysis and kidney transplantation.
It is unknown whether this drug causes thyroid ccell tumors, including medullary thyroid carcinoma mtc, in humans, as the human relevance of exenatide extendedreleaseinduced rodent thyroid ccell. Effects of glucagonlike peptide1 receptor agonists on renal. Precautions and warnings for exenatide there are several precautions and warnings for exenatide to be aware of, including potential drug interactions, the risk of low blood sugar when taken with certain other diabetes medications, and the possible danger of taking the drug when pregnant. This book is distributed under the terms of the creative commons. The objectives of these studies were to assess the. Each presentation of bydureon requires constitution prior to use to obtain a final concentration of 2 mg of exenatide per 0. Pediatric drugs analgesics antihypertensive and cardiovascular agents antimicrobial agents miscellaneous agents sedatives, hypnotics, and other drugs used in psychiatry. Research design and methods in this randomized, placebocontrolled phase 2 study, exenatide lar 0. Diabetes is the leading cause of endstage renal disease, and clinicians are often faced with treating diabetes in patients with varying degrees of renal insufficiency.
The renal drug handbook the st georges hospital, adult critical. Byetta should not be used in patients with severe renal impairment or endstage renal disease and should be used with caution in patients with moderate renal impairment or renal transplantation gastrointestinal disease because exenatide is commonly associated with gastrointestinal adverse reactions, not recommended in patients with severe. Glucotrol xl glipizide dose, indications, adverse effects. There are a number of case reports associating exenatide with the development of acute kidney injury3739. Dec 11, 2014 exenatide is not recommended for use in patients with endstage renal disease or severe renal impairment creatinine clearance exenatide. From april 2005 through october 2008, the agency received 62 reports of acute renal failure and 16 reports of renal insufficiency in individuals taking the drug. Average wholesale cost, based on red book, montvale, n. If exenatide is used in patients with renal impairment or a kidney transplant, closely monitor for adverse reactions that may lead to hypovolemia. The pharmacists will automatically adjust the doses of any of the antimicrobials included in the protocol according to the estimated creatinine clearance generally using the cockroftgault equation for patients. Bydureon is contraindicated in patients with a personal or family history of medullary. Usual dose q24h esrd crcl exenatide extendedrelease causes an increased incidence in thyroid ccell tumors at clinically relevant exposures in rats compared to controls. The dosage should then be titrated to achieve clinical goals.
See instructions for use and full prescribing information for complete instructions. It does not metabolized by dpp4 nor the neutral endopeptidase nep. Learn more about bydureon bcise, an enhanced formulation in a simplified device. Patients taking byetta 10 mcg achieved an a1c reduction of 1. Caution should be applied when initiating byetta or escalating the dose of byetta in patients with moderate renal failure 5. Exenatide has a short plasma halflife and a high molecular weight. It works by increasing insulin release from the pancreas and decreases excessive glucagon release. The dose can be administered at any time of day, with or without meals. The recommended dose of bydureon is 2 mg subcutaneously once every 7 days weekly.
1100 685 39 752 253 620 1505 863 158 1255 1228 913 197 119 630 1015 900 43 1452 1466 1346 449 587 622 1008 941 668 1039 1314 692 69 1230 580 96 683 960 600 825