The FDA provides examples of acceptable documentation for the significant difference determination, including: No Dye X, patient allergy (if the comparable drug contains the dye) Liquid form, patient cant swallow tablet (if the comparable drug is a tablet) 6 mg, patient needs higher dose (if the comparable drug is only available in 5 mg dose) For providers offering weight management services, remember that the prescription documentation needs to establish why combining the GLP-1 with an additive results in a significant difference compared to administering them separately
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GLP-1 receptors are found in parts of the brain linked to appetite, reward, and even stress responses
In glycemic control clinical trials, the risk of hypoglycemia was increased when semaglutide injection was used concomitantly with insulin or an insulin secretagogue (e.g., sulfonylurea)
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