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. 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 intended for patient selfadministration. 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. 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.
In kidney malfunction, or even renal failure, the dose of sitagliptin must be reduced to onehalf or one fourth. The recommended dose of bydureon is 2 mg subcutaneously once every 7 days weekly. Byetta exenatide dosing, indications, interactions, adverse. Research design and methods in this randomized, placebocontrolled phase 2 study, exenatide lar 0. Health, general acute kidney failure care and treatment case studies complications and side effects diagnosis risk factors acute renal failure diabetes diabetes mellitus. Patients taking byetta 10 mcg achieved an a1c reduction of 1. 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. Exenatide is not recommended for use in patients with endstage renal disease or severe renal impairment creatinine clearance dosing is needed. 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. Bydureon is contraindicated in patients with a personal or family history of medullary. Patients with previous arf, endstage renal disease, or dialysis were excluded. Use with caution in patients with renal transplantationor moderate renal impairment 5. There are a number of case reports associating exenatide with the development of acute kidney injury3739. Learn more about bydureon bcise, an enhanced formulation in a simplified device.
Exenatide extendedrelease causes an increased incidence in thyroid ccell tumors at clinically relevant exposures in rats compared to controls. Once weekly dosing is available for albiglutide, exenatide er and dulaglutide. Exenatide has a short plasma halflife and a high molecular weight. Alternatively, may give before the two main meals of the day provided dosing is 6 hours or more apart. Drug dosing adjustments in patients with chronic kidney disease myrna y. See instructions for use and full prescribing information for complete instructions. Byetta exenatide dosing, indications, interactions, adverse effects.
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. This book is distributed under the terms of the creative commons. Exenatide was approved for medical use in the united states in 2005. Case report olgu sunumu, case study by turkish journal of endocrinology and metabolism. Exenatide is excreted only by the kidneys and undergoes fragmentation in the renal tubule. If last enoxaparin was given 812 hr before balloon inflation, an iv bolus of 0. Drug dosage in renal insufficiency has become an toxication. In this study we investigated the effects of continuous exenatide administration from a longacting release lar formulation.
Effects of glucagonlike peptide1 receptor agonists on renal. It works by increasing insulin release from the pancreas and decreases excessive glucagon release. Effect of renal impairment on the pharmacokinetics of. 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. Bydureon bcise exenatide dose, indications, adverse effects. In kidney malfunction, or even renal failure, the dose of sitagliptin must be reduced to onehalf or onefourth.
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. Prior to initiation, train patients on proper mixing and injection technique to ensure the product is adequately mixed and a full dose is delivered. Pancreatitis, allergic reactions and altered kidney function have been reported rarely with exenatide. 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. If exenatide is used in patients with renal impairment or a kidney transplant, closely monitor for adverse reactions that may lead to hypovolemia. 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.
Bydureon exenatide dose, indications, adverse effects. Compared to glp1, exenatide has a longer halflife of 2. 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. Medscape type 2 diabetesspecific dosing for byetta exenatide. 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 an injectable treatment for type 2 diabetes. Bydureon is 2 mg exenatide extendedrelease for injectable suspension for subcutaneous administration once every seven days weekly. Each presentation of bydureon requires constitution prior to use to obtain a final concentration of 2 mg of exenatide per 0. Bydureon bcise exenatide extendedrelease injectable.
The mean antixa level in the moderate renal impairment group after a dose adjustment was 0. Usual dose q24h esrd crcl exenatide extendedrelease causes an increased incidence in thyroid ccell tumors at clinically relevant exposures in rats compared to controls. 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. After 1 month, may increase dose to 10 mcg subcutaneously twice a day based on clinical response. Exenatide is administered subcutaneously and mimics human glucagon like peptide1 glp1. The dosage should then be titrated to achieve clinical goals. Adjunct to diet and exercise to improve glycemic control with dm type 2. Recovery of renal function was incomplete in three of four patients upon cessation or dose reduction of the medication. Pharmacokinetics and pharmacodynamics of exenatide extended. 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. Exenatide is fdaindicated to improve glycemic control in adult patients with type 2.
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. Dec 11, 2014 exenatide is not recommended for use in patients with endstage renal disease or severe renal impairment creatinine clearance exenatide. 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. Use of exenatide in patients with type 2 diabetes diabetes. Renal dosing, risk of hypoglycemia, and fuid balance must be considered when choosing an appropriate antihyperglycemic agent in the presence of renal impairment,14. The objectives of these studies were to assess the. In ckd stage 4 and 5 clearance dosage adjustment required. Effect of renal impairment on the pharmacokinetics of exenatide. Drug dosing adjustments in patients with chronic kidney disease.
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. 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. Objective in patients with type 2 diabetes, exenatide reduces a1c, postprandial and fasting glucose, and weight. Analgesics antihypertensive and cardiovascular agents antimicrobial agents miscellaneous agents sedatives, hypnotics, and other drugs used in psychiatry. The renal drug handbook the st georges hospital, adult critical. A 2year carcinogenicity study was conducted with exenatide extendedrelease, the active component of bydureon, in male and female rats at doses of 0. Caution should be applied when initiating byetta or escalating the dose of byetta in patients with moderate renal failure 5.
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. Dosing guidelines book school of medicine university of. The information on dosage adjustments in renal impairment given in this book is. Munar, pharmd, bcps, and harleen singh, pharmd oregon state university college of pharmacy, portland, oregon. Average wholesale cost, based on red book, montvale, n. Exenatide associated renal failure article in practical diabetes international 276. Exenatideassociated ischemic renal failure diabetes care. 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. Exenatide is not associated with increased acute renal failure.
Glucotrol xl glipizide dose, indications, adverse effects. The authors make no claims of the accuracy of the information contained herein. Lilly camp care packages, supplying children at diabetes camps with book. 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. Exenatide and kidney function nephrology jama jama network. Vice versa, switching from sitagliptin to exenatide produced a decrease of 73 mgdl in 2h ppg level. Exenatide pharmacokinetics in patients with mild to moderate. A prefilled pen with 60 doses of exenatide one month supply costs.
746 1097 1041 520 1157 1362 1151 850 92 1323 968 587 1247 1377 58 1502 722 526 980 1278 514 974 200 460 1386 1308 393 360 935