From the Guidelines
Bydureon (exenatide) is not recommended for use in patients with a GFR < 30 mL/min/1.73 m2 due to reduced clearance and potential for adverse effects. The dosing of Bydureon for patients with Chronic Kidney Disease (CKD) should be approached with caution, considering the patient's kidney function and the potential risks associated with the medication.
Key Considerations
- For patients with mild to moderate CKD (eGFR 30-89 mL/min/1.73m²), the standard dose of 2 mg once weekly can be used without adjustment, but with careful monitoring of kidney function and potential side effects 1.
- The clearance of exenatide is reduced by 36% with a GFR of 45 mL/min/1.73 m2 and by 64% with a GFR of 30 mL/min/1.73 m2, indicating a need for caution in patients with impaired kidney function 1.
- Exenatide has been associated with acute kidney injury or acceleration of CKD progression in case reports, further emphasizing the need for careful consideration and monitoring in CKD patients 1.
Monitoring and Education
- Before initiating Bydureon in CKD patients, kidney function should be assessed, and regular monitoring is necessary during treatment to promptly identify any adverse effects on kidney function 1.
- Patients should be educated about potential side effects including nausea, vomiting, and diarrhea, which may be more pronounced in those with kidney impairment 1.
From the FDA Drug Label
In patients with end-stage renal disease receiving dialysis, single doses of exenatide 5 mcg were not well-tolerated due to gastrointestinal side effects No dosage adjustment of exenatide is required in patients with mild renal impairment (creatinine clearance 50 to 80 mL/min). Caution should be applied when initiating or escalating doses of exenatide from 5 mcg to 10 mcg in patients with moderate renal impairment (creatinine clearance 30 to 50 mL/min) Exenatide is not recommended for use in patients with end-stage renal disease or severe renal impairment (creatinine clearance < 30 mL/min) and should be used with caution in patients with renal transplantation.
The dosing of Bydureon (exenatide) for patients with Chronic Kidney Disease (CKD) is as follows:
- No dosage adjustment is required in patients with mild renal impairment (creatinine clearance 50 to 80 mL/min).
- Caution should be applied when initiating or escalating doses of exenatide from 5 mcg to 10 mcg in patients with moderate renal impairment (creatinine clearance 30 to 50 mL/min).
- Exenatide is not recommended for use in patients with severe renal impairment (creatinine clearance < 30 mL/min) or end-stage renal disease. 2 2
From the Research
Dosing of Bydureon (Exenatide) in Patients with Chronic Kidney Disease (CKD)
- The dosing of Bydureon (exenatide) for patients with CKD is not explicitly stated in the provided studies.
- However, the studies suggest that dose reduction and/or frequency of administration may be necessary for glucose-lowering agents, including exenatide, in patients with impaired renal function to maintain a satisfactory efficacy/safety profile 3.
- The estimated glomerular filtration rate (eGFR) can be used to guide dose adjustment in patients with stable kidney function, but other approaches may be required in certain patient subsets 4.
- Drug dosage adjustment for patients with CKD is an accepted standard of practice, and the Kidney Disease: Improving Global Outcomes (KDIGO) conference generated recommendations for clinical practice, research, and regulatory agencies to improve the quality of pharmacokinetic and pharmacodynamic information available to clinicians 5.
- While the studies provide general guidance on dose adjustment for patients with CKD, they do not provide specific recommendations for Bydureon (exenatide) dosing in this population.
- Other studies discuss the importance of adjusting medication dosing in patients with CKD, including antidiabetic medications, but do not provide specific information on Bydureon (exenatide) dosing 6, 7.