From the Guidelines
Ozempic (semaglutide) can be used in patients with end-stage renal disease (ESRD) and impaired renal function, with no dose adjustment required, as evidenced by the most recent study 1. When using Ozempic in patients with severe renal impairment, it is essential to monitor their condition closely due to potential side effects.
- The medication is primarily metabolized through protein degradation and not eliminated by the kidneys, which supports its use in patients with renal impairment 1.
- However, close monitoring is necessary to manage potential side effects like nausea, vomiting, and diarrhea, which could worsen fluid and electrolyte imbalances in patients with kidney failure.
- Additionally, monitoring for hypoglycemia is crucial if the patient is on other diabetes medications.
- Ensuring adequate hydration and considering scheduling the injection after dialysis sessions can help maintain consistency in the treatment regimen.
- Patients should be advised to report severe abdominal pain, persistent vomiting, or signs of pancreatitis immediately, as these complications may be more serious in the setting of kidney failure. The most recent study 1 provides guidance on the use of Ozempic in patients with renal impairment, and its findings support the safe use of the medication in this population, with appropriate monitoring and precautions.
From the FDA Drug Label
In subjects with renal impairment including end-stage renal disease (ESRD), no clinically relevant change in semaglutide pharmacokinetics (PK) was observed [see Clinical Pharmacology (12.3)]. Patients with Renal impairment - Renal impairment does not impact the pharmacokinetics of semaglutide in a clinically relevant manner. No dose adjustment of OZEMPIC is recommended for patients with renal impairment.
Ozempic (semaglutide) can be used in patients with end-stage renal disease (ESRD) and impaired renal function, as no dose adjustment is recommended for patients with renal impairment, and renal impairment does not impact the pharmacokinetics of semaglutide in a clinically relevant manner 2 2.
From the Research
Safety of Ozempic (Semaglutide) in Patients with End-Stage Renal Disease (ESRD) and Impaired Renal Function
- The use of semaglutide in patients with chronic kidney disease (CKD) has been studied in several trials 3, 4, 5, 6.
- A study published in 2022 found that subcutaneous semaglutide was effective and safe in patients with type 2 diabetes and moderate renal impairment, with a significant reduction in HbA1c and body weight 5.
- Another study published in 2022 found that semaglutide was effective in improving glycemic control and reducing weight in patients with type 2 diabetes and CKD, with a mean eGFR of 50.32 mL/min/1.73 m2 6.
- A multicenter real-world study published in 2023 found that the safety and efficacy of semaglutide in patients with type 2 diabetes and CKD were not notably lower than those in patients without CKD, and that CKD severity barely influenced treatment response 4.
- However, it is essential to note that the European Medicines Agency has approved the use of semaglutide up to a minimal eGFR of 15 mL/min/1.73 m2 3.
- In patients with ESRD, the use of semaglutide requires careful consideration, and dose adjustments may be necessary to avoid adverse effects 7.
Key Considerations
- Patients with CKD require regular monitoring of renal function and dose adjustments of medications as needed 7.
- The use of semaglutide in patients with ESRD and impaired renal function should be individualized, taking into account the patient's overall clinical condition and the potential benefits and risks of treatment 3, 4, 5, 6.
- Further studies are needed to fully understand the safety and efficacy of semaglutide in patients with ESRD and impaired renal function 3, 4, 5, 6.