Can a patient with Impaired renal function on hemodialysis (HD) taking Ozempic (semaglutide) 1mg be increased to 2mg, while also receiving intravitreal Eylea (aflibercept) injections?

From the Guidelines

I would not recommend increasing the Ozempic (semaglutide) dose from 1mg to 2mg for your hemodialysis patient at this time. According to the most recent and highest quality study 1, the maximum FDA-approved dose for type 2 diabetes is 1mg weekly, and there is limited clinical experience with semaglutide in patients with end-stage renal disease on hemodialysis. Renal impairment can potentially lead to increased drug exposure and side effects.

Key Considerations

• The patient's current glycemic control should be assessed before considering any dose increase
• Evaluate for any GI side effects from the current Ozempic dose
• Consult with nephrology to determine the best course of action
• Alternative approaches might include optimizing the current GLP-1 RA dose, adjusting other diabetes medications, or considering insulin therapy which can be more easily titrated in the dialysis population

Medication Interactions

• There is no known direct interaction between Ozempic and Eylea (aflibercept) injections that would preclude using both medications 1
• However, caution is still warranted when using multiple medications in patients with complex medical conditions

Clinical Implications

• Patients with end-stage renal disease on hemodialysis require careful management of their diabetes medications to minimize the risk of adverse effects
• The use of GLP-1 RAs, such as semaglutide, should be carefully considered in this population, and alternative approaches may be necessary to achieve optimal glycemic control 1

From the FDA Drug Label

8.6 Renal Impairment No dose adjustment of OZEMPIC is recommended for patients with renal impairment. 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)].

The patient is on hemodialysis (HD), which is a form of renal impairment. According to the drug label, no dose adjustment of OZEMPIC is recommended for patients with renal impairment, including those with end-stage renal disease (ESRD).

Regarding the dose increase from 1mg to 2mg, the label does not provide information on dose titration or increases beyond the recommended dose of 1mg per week for glycemic control. However, it does mention that semaglutide exposure increases in a dose-proportional manner for once-weekly doses of 0.5 mg and 1 mg 2.

There is no direct information on the interaction between Ozempic and Eylea injections in the eye.

In summary, based on the provided information, no dose adjustment is needed for the patient's renal impairment, but the decision to increase the dose to 2mg should be made with caution and consideration of the patient's individual response to the medication, as the label does not provide guidance on doses beyond 1mg per week.

From the Research

Increasing Ozempic Dosage

• The study 3 describes the efficacy and safety of semaglutide (Ozempic) in patients with advanced diabetes kidney disease in maintenance incremental hemodialysis, but it does not provide information on increasing the dosage from 1mg to 2mg.
• However, the study 4 mentions that the maximum prescribed dose of injectable semaglutide was 1mg in 45.2% of patients, but it does not provide information on the safety and efficacy of increasing the dosage to 2mg.

Eylea Injections and Ozempic

• None of the provided studies 3, 5, 6, 7, 4 mention the interaction between Eylea injections and Ozempic.
• The study 3 focuses on the efficacy and safety of semaglutide in patients with advanced diabetes kidney disease in maintenance incremental hemodialysis, while the study 4 assesses the safety and efficacy of semaglutide in patients with advanced chronic kidney disease, but neither study mentions Eylea injections.

Renal Impairment and Ozempic

• The study 7 investigates the pharmacokinetics, safety, and tolerability of oral semaglutide in subjects with renal impairment, including those with end-stage renal disease requiring hemodialysis, and finds that renal impairment does not affect the pharmacokinetics of oral semaglutide.
• The study 4 also assesses the safety and efficacy of semaglutide in patients with advanced chronic kidney disease, including those on dialysis, and finds that semaglutide appears to be tolerated by most individuals with CKD 4 or greater, despite associated gastrointestinal side effects.